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    VA's Office of Research Oversight conducted an investigation into animal welfare concerns in April 2017.

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    VA's Office of Research Oversight conducted an investigation into animal welfare concerns in April 2017.

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    © All Rights Reserved
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    499 views42 pages

    VA Office of Research Oversight Report

    Uploaded by

    Daily Caller News Foundation
    VA's Office of Research Oversight conducted an investigation into animal welfare concerns in April 2017.

    Copyright:

    © All Rights Reserved
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    OFFICE OF RESEARCH OVERSIGHT FOR-CAUSE REVIEW: CANINE RESEARCH STUDIES AND ASSOCIATED FACILITY OVERSIGHT Hunter Holmes McGuire VA Medical Center Richmond, Virginia May 30, 2017 Veterans Health Administration CONTENTS Pope EXECUTIVE SUMMARY soc Enea Sonatiiebcl assim |. INTRODUCTION AND METHOD OF REVIEW ne Il, PROGRAM AND RESEARCH OVERVIEW .. 5 x Il, ASSESSMENT OF ALLEGATIONS REFERRED TO ORO BY THE VA INSPECTOR GENERAL sso: IV, ADDITONAL FINDINGS AND KEUUMED ACHIONS, aw V. SUGGESTIONS Vi CONCLUSIONS ss APPENDIX A: Facility Representatives and ORO Review Team. at APPENDIX: Documents Reviewed nse sn . Ba APPENDIX C: VMU Fincings ca Rap [ATTACHMENT I; Requlted Action Plan. ‘Supporting Documents HV for Section Mh. -Avalable Upon Request ‘sean myn ifornaton wh site the ses Py F394 (USC 2 heme eth Inara Frtly nd Necuy ht ERA 6 Pat Tie 38 USC. sate SO whch prone aac eco he aero dann yt 3 a fh Has ed oe Any oa ni ee ae estas hw ay ie he sao os as. Ay frie Ae USS. Hretop 055000 Shtan oey de SCF, Pate Ban - eet azole mane ter {a0uSc sor mel wesc ecstatic an wo sa100 seta see fee {RUSE sn mat qteso\ theater eth tes ot om ene ete Inanten he std sets et ove Vem Wo anne kl ee se te my ho eo ‘Seine day aes er ‘neta ere eran At eft opt cnpeerter ell sete ihe eit ea te van sou omer) pe 4556 Executive Summary - ORO For-Cause Review: CANINE RESEARCH May 30,2017, Hunter Holmes McGuire VA Medical Center EXECUTIVE SUMMARY (On March 30, 2017, the VA Office of inspector General (OIG) referred a complaint regarcing canine studies conducted atthe Hunter Holmes McGuire VA Macical Center (HHRVAMIC) in Richmond, VA, tothe Office of Research Oversight (ORO) for investigation. The OIG referral ‘outlined eight alegations seven of which pertained to alleged animal welfare concerns, recordkeeping and reporting violations, anda fallure to make appropriate public disclosure of the studies. An eighth allegation that pertained tothe clinical privileges af sn HHMVAMC study ‘team member was determined, in consultation with 01, ofall outside the scope of ORO's purview. “To address the allegations, ORO: conducted interviews with HHMVAMC personnel responsible for providing local oversight af animal research and study team personnel conducting research Involving dogs; reviewed various faclity documents pertaining to the oversight and conduct of the studies referenced inthe complaint, and conducted an on-site inspection atthe fcity on ‘April 18-21, 2017. ‘With regard tothe specifi allegations referred by O16 ‘+ ORO was able to substantiate some but not all aspect ofthe allegations constituting animal welfare concerns. ORO substantiate the inappropriate administration of a sedative, failure to provide appropriate postoperative care, and the occurrence of unanticipated surgical complications. However, ORO could not conclusively determine thatthe surgical ‘complications referenced inthe allegations were evidence of “negligence” or “incompetence” onthe part of the Principal Investigator (PI) as alleged. ORO also ‘ascertained that after each ofthese incidents, which had been previously sel-identiied and ‘appropriately reported by HHMVAMC personnel, the local Instittionel Animal Care and Use Committee IACUC) appropriately implemented progressive corrective actions to address the concerns, including ultimately suspending the privileges ofthe Principal Investigator to conduct animal research, + ORO did not substantiate the allegation that HHMVANIC falled to report tothe US. Department of Agriculture (USDA) that any dogs were used in research at the fcilty in fiscal year (FY) 2016, USDA provided ORO with a copy of HHMVAMC's annual report for 12016 and ths report did infact indicate that HHMIVAMC reported doge were used in research at the faclity during FY2026. However, ORO di identify that there were ‘inaccuracies in reporting the precise numbers of dogs used in research, @ Bie YA en me Executive Summary - ORO For-Cause Review: CANINE RESEARCH May 30,2037 Hunter Holmes McGuire VA Medical Center ‘+ ORO did not substantiate that there was.a regulatory failure to adhere to “requirements” to publicly cisclose the dog experimentsin federal reporting database used to capture Information regarding federally supported grants. Further, ORO did not substantiate that there were any violations ofthe Animal Welfare Act with regard to the reporting ofthe adverse events referenced in the complaint + ORO did not substantiate the allegation pertaining to HHMVAMC lacking tracking records of ‘oversight and experimental failures, Specifically the faciity was able to provide records of ‘adverse events and other incidents thet were reported tothe IACUC. In addition to the findings made with regard tothe allegations referred by O16, ORO made a numberof additional findings related to the canine research studies and associated oversight by HHMIVAME, including: ‘+ Lackof documentation to establish whether animals wore appropriately evaluated and received supportive care; + Non-adherence to provisions ofthe witten Program of Veterinary Care; *+ Deviations from approved study procedures and implementation of changes to studies without prior IACUC approval; + Protocols that lacked necessary information to inform the IACUC's review and approval process; and ‘+ Deficient reporting and recordkeeping practices with regard to animal usage and disposition, \Within 30 days of receipt of thisreport, HHMVAM willbe required to develop2 remedial action plan specifying the actions to address the flings Inthe report and timely completion dates. HHIAVAMC has notified ORO that a number of corrective actions have already been Initiated that will address the findings contained inthis report FOR-CAUSE REVIEI CANINE RESEARCH AND ASSOCIATED FACILITY OVERSIGHT Hunter Holmes McGuire VA Medical Center flchmond, Virginia Onsite Review Dates: April 18.21, 2017 Date of Report: May 30,2017 |. INTRODUCTION AND METHOD OF REVIEW ‘The Office of Research Oversight {ORO} serves as the primary Veterans Health Administration (VAR) office for advising the Under Secretary for Heath (USH), and conducting compliance ‘oversight, relative to the protection af human research subjects, laboratory animal welfare, ‘esearch safety, research laboratory security, research information protection, and research ‘misconduct. ORO also oversees Governmentwide debarments for research impropriety and conducts education programs for facility Research Compliance Officers (RCOS). The ORO Research Safety nd Animal Welfare (RSAVY) group conducted an On-Site For-Cause Review (FCR) of facility oversight of canine esearch atthe Hunter Holmes McGuire VA Medical Center (HHMIVAMC) on April 18-22, 2027. ‘This review was intlated in response toa VA Office of Inspector Genoral (O16) referral that included allegations of animal abuse and recordkeeping violations associated with canine research performed at HHMVAMC, The scape of ORO's review included: (1} conducting a post-incident investigation to determine the merit of allegations presented inthe O1G complaint; (2) determining ifthe Principal Investigators) (PIs) conducting canine research at the HHMVAMC followed adequate protocol procedures while performing surgeries and administering postoperative care; nd (3) evaluating local oversight mechanisms, including the HHMIVAMC Institutional animal Care and Use Committee (ACUC], and animal care procedures for active canine studies, to determine the level and adequacy of oversight provided for canine research. Specific responses regarding the "sot tine teal cae No, 201-0762. (2017 6882 VAMCRron, VAR. 12 dated Nard 30,2017 Page 1 of 38, Hunter Holmes MeGulre VA Medical Genter May 30,2017, ‘merit ofeach allegation listed in the O16 request are provided in Section Il ofthis report. ‘Additional findings from ORO's review are provided in Section IV of this report. ‘The ORO review team conducted group and incvidual interviews with faclity leadership, research service leadership, the Veterinary Medical Consultant (VMC), Pl, animal research personnel, and members ofthe IACUG, including the Chair (ee Appendix A). The ORO review team conducted a review of selected Animal Care and Use Prosram {ACUP) documents focusing inthe canine research program, including: policies, plans, ACUC minutes, standard operating, procedures (SOPs), scope of practice records, training materials and documentation, canine ‘Animal Component of Research Protocole (ACORP, canine acquisiton/dispostion records, and Surgical and medical records (see Appendix B). The ORO team also conducted a physical Inspection ofthe Veterinary Medical Unit (VMLU} (see AppendixC). PROGRAM AND RESEARCH OVERVIEW (Oversight ofthe HHMVAMC research program was provided through the HHMVAMC Research ‘and Development Committee (REDC] and corresponding subcommitiees with delegated authority for specific program areas. Primary oversight ofthe ACUP was provided by the HHIMVAMC IACUC. The ACUP maintained » curcent Public Health Service (PHS) Arieval Welfore ‘Assurance (No. A 4369-01) with the National Institutes of Health - Office of Laboratory Animal ‘Welfare (NIH-OLAW) and ful accreditation with the Assocation for the Assessment and ‘Accreditation of Laboratory Animal Care, International (AAALAC; Unit No, VA-O61), and was registered withthe US, Department of Agriculture - Animal and Plant Health Inspection Service (USDA-APHIS; Registration No.52-V-0008). The HHMVAMC was affliated withthe Virginia. Commonwealth University (VCU), Richmond, VA; however, at the time of ORO’s review, no VA canine research was conducted at this or other offsite locations). “The HHMVAMC research program was supported by a VMC, contracted through the nonprofit corporation, the MeGulre Research Institute. The VMC provided coverage of the entre animal research program, not solely the canine research, and during onsite Interviews state that he was present at the facility Between 20 to 6D minutes per week to provide program oversight {and animal care. The facility had aful-time VM supervisor and two full-time animal husbandry staff, supporting the entire ACUP. Two full-time research technicians supported the four Principal Investigators (Ps) who conducted canine research, providing support during surgeries and other experimental interventions as well as intra/postoperative monitoring ofthe dogs; addtionaly, one of these technicians had part-time animal care dues. Some of these Page 20138 Hunter Holmes McGuire VA Medical Center ‘May 20,2017 staff also had rodent care responsibilities and participated In ther research-related activities and committees. “The HHMIVAMC had sit approved research protocols invelving the use ofa canine animal ‘model. See Appendix, tem 36. A seventh protocol was pending IACUC approval at the time ‘of ORO'S site vst. The canine research portfolio focused primarily on cardiac physiology and function, and reflected a range of scientific aims and potential applications, Four Ps were Involved inthe research. Three ofthe sx studies were investigating the underlying physiology ‘and consequences of premature ventricular contractionsby: (a) comparing the effects of premature contractions of the upper and lower heart chambers the atria and ventricles, respectively; (b) assessing the impact of premature contractions (arhythmias) on the development of cardiomyopathy (disease ofthe heatt muscle often leading to heart failure); (e) Investigating the relationship between the nerves that innervate the heart an¢ kidney and the development of arrhythmia and carélomyopathy; (d) determining if injection of nanoparticles containing diferent compounds can prevent arshythmias; and (e) assessing how the time Interval between the premature ventricular contractions and normal contractions affects the development of ventricular dysfunction, A fourth study sought to determine ifthe incidence ‘and inducibility of atrial flbrlation (upper chamber arshythmia) could be inhibited by exposing ‘cardiac nerves to pharmacologic agents such as botulinum toxin or ealkium chloride. A fith study aimed to assess and deine te effects of two techniques used te destroy cells in specific regions ofthe heer, to treat rhythmic abnormalities in humans. The sixth study examined the physiology of left ventricular remodeling after a heart attac, and to asses the relationship ‘between arrhythmia and left ventricular remodeling, with and without & premature ventricular contraction challenge. ‘The procedures approved forthe studies included: surgery Ithoracotomy, survival surgery, ‘multiple survival surgeries, and terminal surgery with tissue harvest); implantation of pacemakers; insertion of eatheters into heart chambers fr blood sampling: induction of cardiac contractions and arrhythmias; cardiac biopsies; implantation of subcutaneous raciotelemetry devices with channel connections to permit recording of cardia and renal nerve activities; Injections of ative substances (eg, nanoparticles releasing botulinum toxin); cardiac tissue ablation (destruction) using catheters to apply radiofrequency energy (heating) or cycles of freezing and thawing erycablation); the injection of iqud latex into the coronary artery to ‘cause a myocardial infarction (heart attack); echocardiograms; intravenous administration of short ating vasoactive drugs; and treadmill exercise ‘The stated goal ofthe research was to galn a better understanding ofthe underlying ‘mechanisms behind the development of cardiac abnormalities and cardiac physiology, with the Page 3 of 28 Hunter Holmes McGuire VA Medical Center May 30,2017 Llimate goa of developing treatments for these conditions in humans. The Ps justified the se of canine subjects (in leu of alternate animal models} based upon: (2) the similarities between canine and human cardiac physiology, including the cardiac electrical conduction systems; (b) the sie of canine hearts (permitting pacemaker implantation, the induction of sustained arrhythmia, and the insertion of ablation catheters); and (e the adaptabilty of canines to instrument implantation compared to other lage animals. Funding forthe dog projects conducted at HHMVAMC was provided by various sources including the US Public Health Service (Nil), the American Heart Association, the McGuire Research Institute (the VA's nonprofit research foundation) and other non-profit entities. Between December 2015 and November 2016, several neidents Involving canine research were reported tothe ORO RSAW team and to the National Institutes of Health Olie of Laboratory ‘Animal Welfare (NIH-OLAW). These ceports, involving ane Principal Investigator (P), detailed series of adverse events, including animal deaths that occurred asa result of the research conducted under an IACUC-2pproved protocol at HHMVAMC. In response to these adverse ‘events, the HHMVAMIC IACUC Implemented a series of progressive resrictons and conditions onthe Fland the research. After discussions with the Medical Center Director and the Associate Chief of Staff for Research (ACOS/R), the IACUC suspended the privileges and mandated that another investigator assume primary responsibilty forall animal work, although the orignal Pl was permitted to be involved in aspect ofthe research that did not include handling animals. These incidents were specifically referenced in the allegations referred by O16 to ORO. ‘animal research IL, ASSESSMENT OF ALLEGATIONS REFERRED TO ORO BY THE VA OFFICE OF INSPECTOR. GENERAL (On March 30,2027, the VA OIG referred several allegations to ORO that pertained to dog research conducted at HHMIVAMEC (VAGIG Hotline Referral Case No. 2017-02763-Hl-0912; (2017-16882). These allegations stemmed from a complaint dated March 21, 2017, that was received by VA O16. The allegations, which are repreduced verbatim frm the VAIG referal, and ORO’s assessment ofthe allegations, ere presented below. 1. Allegations ‘2. Animal welfare abuse concerning dog experimental laboratories between December 2015 and Novernber 2016. Spectcal Cfuoce y Page 4 of 38 Hunter Holmes McGule VA Medical Center ‘May 30,2017 (1) December 2015, the Principal investigator negligently gave a dog a sedative ‘overdose during an experimentol surgery and feild to provide adequate post procedural veterinary core that neorl killed the dog. (2) Anal 2016, following a surgery by the Principal investigator to sever a dog's cardige nerves, the dog drastically deteriorated in health and ultimately dled of @ hear attack during an experiment. Additionally, another dog that underwent the _zame surgery by the Investigator experienced rapid heath decline and was kiled. The report determined sloppy and incompetent surgeries killed the animols. (3) Wovember 2016, the Principal investigator killed another dog by cutting into the dog's chest to expose the heart ond incompetenty sliced into the dog's hung. 1 Record Keeping violations: (2) VAM submitted a report to U.S. Department of Agriculture, indicated that no dogs were held or use in experiments in FY 2016; however, the sel reported dog abuse violations listed are incontrovertible evidence that dogs were subjected to painful end distressful experiments in FYI6. (2) VAMC filed to publicly disclose dog experimentol projects inthe Federal Reporter System, (2) These incidents have not been reported to the Secretory ofthe VA as requited by Jaw, (4) VAMC lacs tracking records of oversight and mismanagement of experimental fallres. The Principal Investigator whose repeated botched surgeries an dogs led to revocation of their experimentation privileges s stil ted as an active physician treating veterans at McGuire VAMC. 2. Assessment of Allegations a. Allegation 1a(1). “December 2015, the Principal Investigator negligently gave a dog ‘a sedative overdose during on experimental surgery and filed to provide adequate ‘poet procedural veterinary care that nearly led the dog.” (1) Method(s) used by ORO to review the allegation. (a)Review of documents related to thisincident, including: surgical and ‘medical records for this dog, IACUC meeting minutes felliy reports to (ORO, OLAW, and AAALAC, and ORO case fils. @ te oe Hunter Holmes McGuire VA Medical Center May 30,2017, (b} interviews with IACUC members, the Pl study staf, the VIC, and VU staff (2) Determination by ORO regarding the substance ofthe allegation. (2) This allegation is substantiated, {(b) Review of documents and interviews with facity personnel indicated that a dog on protocol 02002 received an averse of pentobarital during a surgical procedure conducted on December 1, 2015, and that the PI falled to provide adequate postoperative care. The overdose was «result of the infitration ofan intravenous catheter, failure of staff to detect the infitration, and fallur to consider that the extravasated drug would be absorbed slowly overtime and could result in an overdose. At the conclusion ofthe procedure, the Pl monitored the animal for several hours but left the facity before the animal had fully recovered without arranging for another individual to monitor the dog. The situation was ‘compounded when a technician arrived the next morning and administered a narcotic for pain relief, as specified in the approved protocol, without realizing thatthe dog had already recelved an ‘overdose of pentobarbital or fully assessing the dog's condition. The IACUC reviewed these events ata convened meating and determined the Principal Investigator “alld to provide adequste veterinary care by faling to monitor the IV line during surgery, giving an overdose of pentobarbital during surgery, fling to provide adecuate postoperative supportin the way ofV fluids and proper warming, falled to monitor the dog uni it was completely recovered and left the dog na state that could have led to death.” ORO concurs with the IACUC’s determination and finds that collectively these falures constituted negligence’ on the part ofthe Pl (2) Summary of corrective actions taken and/or required to address an resolve the Issues and to prevent a recurrence {a)intial responses. The moming after the anima’ surgleal procedwe, ‘the VMU Supervisor was notified ofthe dog's coneition upon arrival, and Immediately contacted both the Pl and VMC. Under the direction ofthe "tare terete caret enon pre gron woul rere theca va @% Page 6 0f 38, Hunter Holmes McGuire VA Medical Center May 30,2017 YMC, emergency supportive treatments were initiated. The dog's condition slowly improved and by the folowing day the animal had recovered. (b)Adeitional responses. The IACUC reviewed the event on December 2, 2015, and initiated the following corrective actions: (1) addtional survival surgeries were placed on veterinary hold (2] the Pl was required {w revise the protorol tv address intrauperative anesthesia, Include procedures for monitoring animals during surgery, and update postoperative monitoring procedures; (3) the PI was required to submit 2 letter to the IACUC detaling the incident and provide plan to prevent a recurrence, including descriptions of titration methods for anesthetics, ‘and emergency procedures tobe used in case of adverse events; (4) the Pl was required to maintain detale intra/postoperative records for each animal; (5) the Pl and technician were required to complete adcitional training, including training on controlled substances and anesthesia agents, their side effects and contraindication, and procedures to deal with postoperative distress; (6 all investigators were required to certify (with signature) that they understood the requirement for postoperative ‘monitoring until the animals ae sternal and responsive and to have access and contact information for 24-hour emergency procedures (7) revision ofthe Animal Handler competency form to add sections on controlled substance safety and postoperative care; (8) all research staff Using barbiturates or opiates were required to receive specialized training (9) the next survival surgery was required tobe observed by the YMC; and (10) the incident was determined to be reportable to ORO, (OLAW, and AAALAC. (8) Timeframe for corrective actos (Le, completed and/or required). {a)0n February 3, 2016, the IACUC determined that all requted actions had been completed and rescinded restrictions it had placed on the research, {(6}ORO was initially notified ofthe event on December 3, 2015, an after ‘receiving an update notifying that all corrective actions had been completed, closed the case on February 23, 2016. Note: ORO tracked this incident as Case No. 652-0017-A. (5) Summary of documentation supporting the determination Valea Male Page 7 of 38 Hunter Holmes McGuire VA Medica Center ‘May 30,2017 (a) Facility report to ORO (Supporting Document I) (b) Relevant portions of ACUC Minutes (a acucyResearch Service Protocol Fle (6) The value of recovery or savings: N/A (7) Name and position ofthe reviewer: ORO RSAW (AppendixA Sil) b.Allegtion 1a(2). “April 2016, following a surgery by the Principal Investigator to sever ‘dog's cardiac nerves, the dog drastcaly deteriorated in health ond ultimately died of a ‘heart attock during an experiment. Additionally, another dog that underwent the some surgery bythe Investigator experienced rapld health decline and was killed. The report determined sloppy and incompetent surgeries killed the animals.” (1) Method(s) used by ORO to review the allegation. (a) Review of documents related to this incident, including: surgical and Imedleal records for these dogs, JACUC meeting minutes, and Facility reports to ORO, OLAW, and ARALAC, and ORO case fies, (b) Interviews withthe IACUC, Pl and study staff, the VME, and VMU staff. {2) Determination by ORO regarding the substance ofthe allegation. {o) Thisallegationis partially substantiated. {(b} Review of documents and interviews with facility personnel confirm that in March 2016, two dogs on protocol (2002 underwent surgery t0 Isolate and ablate certain cardiac nerves and subsequently developed severe gastrointestinal complications and were provided supportive care. ‘The surgical procedure required isolating eardine nerves from the rain ‘unk of the vagal nerve; this main trunk lso contains fibers innervating, ‘other organs in adltion tothe heart. The IACUC determined that although the other fibers were not intentionally disturbed, manipulation ofboth the left and right vagal nerves ina single procedure likely Aisrupted nervous contro of digestive function, resulting in signiicant rnguses etary, snr, ad wright loss. Neier ofthe Joys ha heart attack or myocardial infarction. One of these dege developed ventricular fibrillation and dled while undergoing a subsequent IACUC approved procedure; the second dog was euthanized during an ]ACUC- approved terminal procedure. Neither the |ACUC report provided by the facility nor interviews wit facility personnel suggested that "sloppy and Page 8 of 38, Hunter Holmes McGuire VA Medical Center May 30,2017, Incompetent surgeries” resulted inthe deaths, as stated inthe allegation. In sum, ORO concludes that unanticipated surgical complications did joceur and that one dog subsequently died while undergoing an approved research procedure, and the second dog was euthanized; however, ORO ‘ould not conclusively determine that the surgical complications were ‘evidence of “incompetence” on the part of the Plas alleged. (9) Summary of corectve actions taken and/or required to address and resolve the issues and to prevent a recurrence. (a) Initia responses. Both animals were provided with veterinary supportive care. (0) Adlional responses, With the veterinarian and IACUC’s approval, one adelitional dog underwent surgery to perform a unilateral (ane sided) manipulation ofthe vagal nerve and ablation of the cardiac nerves utilizing extremely careful tissue handling techniques. This ‘animal recovered without any adverse events. The IACUC reviewed the ‘events and devised a corrective action plan including: 1} close veterinary supervision; (2) modification ofthe protocol o include unitateral surgery on four additional dogs with ongoing IACUC ‘monitoring; (3) oversight of surgeries by an experlenced co-investigator; and (4) review/observation by the VMU supervisor. Once completed, the Pl submitted a report to the IACUC. Because these four additional animals experienced only mild, manageable clinical signs following the unilateral denervation, the IACUC permitted the Pl to submit an amendment, for sequential denervation surgeries one side at atime, with a recovery period in between), which was subsequently approved. Remaining surgeries were completed without adverse events. (4) Timeframe for corrective actions (.e, completed and/or required). {2}0n September 28, 2016, the JACUC determined that all approved ‘daltional surgeries (beyond the inital two problematic surgeries) had ‘been completed with only minor complications. (6)0RO was initily notified ofthe events involving the fist two problemati surgeries, on Api 7, 2016, and allowed the Implementation of corrective actions. ORO was updated by the faclity ‘on September 30,2016, and closed the case on October 4, 2016. Note: ‘ORO tracked this incident as Cases No, 652-0021-A, Page 9 of 38, Hunter Holmes McGuire VA Medical Center ‘May 30,2017 [5) Summary of documentation supporting the determination {a} Faciity report to ORO (Supporting Document I) {(b) Relevant portions of ACUC Minutes {c) IACUC/Research Service Protocol Files (6) The value of recovery or savings: N/A (7) Name and postion of the reviewer: UKU KSAW (appEnaiX SI) & Allegation 1a(3). “November 2016, the Principal investigator killed another dog by utting into the dog's chest to expose the heart and incompetent sliced into the dog's lung.” (1) Methods} used by ORO to review the allegation. {a}Review of documents related to this incident, including: surgical and medical records for this dog, ACUC meeting minutes, fality reports to (ORO, OLAW, and AAALAC, and ORO case fs (b)interviews with the IACUC, Pl and study staff, the VA, and VMU staff. (2) Determination by ORO regarding the substance of the allegation. (a)This allegation is partially substantiated. (b)The Pt was performing a surival surgery on a dog on protocol 02235 three weeks after a previous surgery on the same dog. He encountered ‘numberof tissue adhesions (a known potential complication of repeated thoracotomies) with sore of the adhesions being more prominent than typically seen. As the Pl released a particulary dense ‘adhesion, it appears (In hindsight) that damage tothe lung tissue ‘occurred, but was rot detected at that time. At the conclusion of the ‘surgical procedure and upon removal ofthe tracheal tube, blood was ‘noted onthe tube. The animal quickly became hypoxic end die before ‘emergency treatment or euthanasia could be provided. On necropsy, it ‘was noted thatthe animal had a laceration and damage to the lune, “which kely contributed to the animals death. ORO notes that during 2 review ofthe incident by the IACUC, one member submitted a minority ‘opinion indicating tat "[t)he lack of foresight and preparation by the investigator prior to [the] surgery [led the IACUC member} to belove the Investigator has a general sense of unintended reckless behavior.” However, an extensive review of documents and interviews witha range liana YA age 10038 Hunter Holmes McGuire VA Medical Center May 30, 2017 of facility personnel did not produce sufficient evidence that the surgical complication was a result of the P's incompetence or that the Pl acted recklessly with regard to the removal ofthe tssue adhesions {3) Summary of corrective actions taken and/or required to address and resolve the Issues and to preventa recurrence. (aimmediate actions, The cause of death was investigated. (b)Adaltional actions. The Vic stopped all panned surgeries on animals with na prior procedures, but allowed activites to cantinue an animals already involved in the study with additional veterinary observation {those procedures were conducted without complications). The Plwas required to meet with the ICUC Chair. The IACUC dscussed this event ‘and determined that it was a reportable event to ORO, OLAW, and AAALAC. The IACUC required the Pl te submit an amended ACORP to adda description ofthe risk of pleural adhesions and to re-characterize this study as a pilot protocol that could lead to unexpected outcomes. ‘Additionally, the ICUC require the following corrective actions: (1) Updating ofthe postoperative monitoring section of the protocol to provide additional safeguards and monitoring; (2) Imiting surgical procedures to once a week: (3) requiring the Pl to contact other cardiac researchers conducting similar procedures to gain information on ‘potential procedural complications; and (4) requiring a second surgeon tobe present forall urpcal procedures. The IACUC acknowledged the previous counseling and veterinary monitoring [At subsequent convened IACUC meeting, the Institutional Official (10) (the Facility Director inthe VA system} and the Associate Chet of Staff {for Research (ACOS/R&D} were In attendance to discuss an unrelated matter. With input from the IO, the VACUC determined thatthe current study Pl should be replaced with a more experienced surgeon (an individual who had previously participated as a sub-investigator on ‘rotocol 02235). The IACUC also determined thatthe more experienced surgeon would replace the current Pl on another protocol (02002, the study related tothe fst two allegations above), and tht the current PL could remain on both protocols in a non Pl capacity, but would not be Permitted to participate in any animal work (Le, limited to observation oni). Page 11 0f 38 Hunter Holmes McGuire VA Medical Center May 30,2017 [A special IACUC meeting was convened on December 12,2016, to approve modifications tothe protocol, At the next convened IACUC ‘meeting in January, the IACUC approved an action plan forall protocols involving the former P(e, the Pl who was replaced asa result of these incidents). The action plan noted that: the investigator was removed as irom protocols 02002 and 02235, and is not permitted to participate in any animal procedures related to these protarak. The new lead, wha replaced the investigator, will perform all animal surgeries and procedures. The former Plis permitted to continue with selentiic evelopment and data anaiysis. The former I may remain asa sub- Investigator on two adaltional protocols (01549 and 01946), but may only ‘observe animal procedures on those protocols. As ofthe date ofthis, report, the IACUC continues to monitor the situation and has not restored any animal procedure privileges tothe former Pl. Additionally, the IACUC requested that a cardiothoracic surgeon observe and consult ‘withthe new lead surgeon regarding lung lssue hemostasis techniques. (4) Timeframe for corrective actions ji {2)Asof the writing ofthis report, all eorectve actions have been implemented and/or completed. The IACUC has not restored any of the former P's animal procedure privileges. completed and/or required. (6}0RO was initially notified ofthis event on November 14,2016, and was continuing to monitor progress at te time the O1G referral was received. Future follow-up ofthis matter willbe combined into this for-cause review case, Note: ORO continues to trock this incident as Case No, 652. 0030-4. (5) Summary of documentation supporting the determination {a}Factity report to ORO (Supporting Document Il) {b)Portions of ACUC Minutes (e)1ACUC/Researeh Service protacal (6) The value of recovery or savings: N/A (7) Name and positon of the reviewer: ORO RSAW (Appendix Ail) 4. Allegation 1b(1). “VAMC submitted a report toUS. Department of Agriculture, Indicated thot no dogs were held or used in experiments in FY 2016; however, the Page 12 of 38, Hunter Holmes McGuire VA Medical Center May 30,2017 selfreported dog abuse violations listed are incontrovertible evidence that dogs were subjected to polful and distressful experiments in FYI6.” {2} Method(s) used by ORO to review the allegation, (a) Review of the report provided by the complainant, (b)Review of a copy ofthe HHMIVAMC annual ceport for FY 2016 obtained recy from USDA, Animal Plant Health Inspection Service, Animal Care (USDA-APHIS-AC). (c)interviews with key personnel incuding the VMU Supervisor. {2) Determination by ORO regarding the substance ofthe allegation. (2) The allegation isnot substantiate. (b)A document accompanying the complaint that was provided to O1G was purported to represent HHMIVAMC's FYI fling to USDA on the number of regulated species used in research atthe facility. Ths purported fling Indicated that “0° dogs were reported as being used atthe facity. This document, however, does not reflect what USDA has on file as being submitted by HHMVAMC for FYI6. Specifically, the HHMVAMC's “Annual Report of Research Facility” on fle with the USDA (a copy of ‘which was provided to ORO by USDA-APHIS-Animel Care), signed by the MCD October 12, 2016", indicates thata total of29 dogs were reported as being used for research or held under the control ofthe HHMVAMC in FY2016. Thus, the information submitted in support of the ‘complainants allegation (that no dogs were report! for 16) does not ‘match that which s contained in USDA's official records While thi allegation that the facity did not report any dog use in FY2016 [snot substantiated, ORO did determine thatthe reported number of gs used at HHIMVAMC in fiscal years 2014-2016 was not accurate (See Section IV ofthis report, Finding 4). This discrepancy appears to be the result of a misunderstanding ofthe appropriate reporting practices rather than an intentional misrepresentation of animal numbers (eg. if ‘dog was present in multiple years it appears the dog was only reported ‘once rather than in each year it was present) Year 205" bats ened 20 Wat te oy opiate ors ware and io epan F0i8 at YA iia Suan Page 10138 Hunter Holmes McGuire VA Medical Center May 30,2017 {3) Summary of corrective actions taken and/or required to adress and resolve the issues and to preventa recurrence. {a}When ORO questioned facity staf regarding the animal numbers reported, the facility acknowledged they had recently recognized the (6) ORO will request submission of amended annual reports to USDA to correct the under-eporting of animal use. (4) Timeframe for corrective actions (ue, completed and/or required}. [a)ORO wil track remediation ofthis noncompliance via @ Remedial Action Plan tobe initiated after issuance ofthis report. (5) Summary of documentation supporting the determination {a)A copy ofthe HHMVAMC USDA Annual Report of Research Faclity for Y16, obtained by ORO from USDA-APHIS and ema correspondence with USDA-APHIS. (Supporting Document IV) (b)"Canine admissions” forms, the “Dog Log" and animal records obtained from HHVAMC. (6) The value of recovery or savings: N/A (7) Name and position of the reviewer: ORO RSAW (Appendix AS) Allegation 1b(2). “VAMC filed to publicly disclose og experimental projects in the Federal Reporter System.” (2) Method{s) used by ORO to review the allegation. (o)Access to and queries ofthe Federal RePORTER website at hitps//federalreporter.sih.gou (accessed on May 3, 2017). Federal RePORTER database search [search criteria included Funding Agency; Principal investigator (P}) Name; Organization; State/City; Fiscal Year (FY), and access to the STAR METRICS® website at bntps/vuwrstarmetrics nih pov/Star/About (accessed on May 3, 2017) (b)Email query to Federal RePORTER contact listed on the website {)Review of HHMMVAMC protocol sts, ACORPs, and other related documentation in protocol files Page 14 of 38 Hunter Holmes McGuire VA Medical Center May 30,2017 (<)interviews with key personnel including the Research Service, IACUC, and Ps. {2} Determination by ORO regarding the substance ofthe allegation. {a} the allegation i not substantiated with regard to any regulatory noncompliance (biFederal RePORTER is a federally funded searchable database, managed by STAR METRICS®, that utilizes exstng administrative data from federal ‘funding agencies to enable public access and assessment ofthe impact ‘of faderally funded research and dovelopment investments. ORO Identified the funding sources for all ACUC-approved canine research at HHMVAMC. The VA was not lsted as a funding source on any of these. projects. Of the six dog studles, one funded entirely by PHS was ‘retrieved from Federal RePORTER. The remaining five canine studies at HHIMVAMC were supported by funds from non-Federal sources, and per the FAQ section of the STAR METRICS® website, projects sponsored by non-federal sources shoulé not be included inthe Federal RePORTER database, Moreover, an NIH contact Isted on the Federal RePORTER. ‘website indicated to ORO that providing information tothe database is voluntary. Thus, tothe extent that HHMVAMC did nat disclose some or all ofits dog studies inthe Federal RePORTER system, such declosure i ‘not required norin many cases relevant (for studies funded by non- Federal sources). {3) Summary of corrective actions taken and/or required to adress and resolve the issues and to prevent a recurrence, [a)No corrective ations are requited. (4) Timeframe for corrective actions (i.e, completed andor require). (@)N/A (6) Summary of documentation supporting the determination (a)Access to and review ofthe Federal RePORTER and STAR METRICS* websites, (b)lnformation provided by emi from NIM. (Supporting Document V) {Funding sources as identified in the approved ACORPS for each ofthe six urrent canine research studles approved by the HHNIVAMCIACUC. Page 15 of 38 Hunter Holmes McGuire VA Mecical Center May 30, 2017 (6) The value of recovery or savings: N/A [7) Name and postion ofthe reviewer: ORO RSAW (Appendix AS) {Allegation 2b(3), “These incidents have not been reported tothe Secretary of the VA ‘5 required by law.” (1) Methods) used by ORO to review the allegation. (2) Review of reporting requirements under the Animal Welfare Act 35 ‘written in 9 CFR, Chapter I, Subchapter A, Part 2, Subpart C§§ 2.31 and 237 {]Review of ORO case records and HHMVAMC semi-annual reviews of rogram for humane care and use of animals and semi-annual reviews of animal faites and study areas. {2) Determination by ORO regarding the substance ofthe allegation. (2) The allegation is not substantiated. (b)Based on reporting requirements under the law as found in the Animal Welfare Act (AWA), a8 written in 9 CFR, Chapter, Subchapter A Part 2, Subpart ¢§§ 2.31" and 2.37%, no events occurred that were reportable to the Secretary of VA(SECVA). The above cited sections ofthe AWA {demonstrate that nly uncorrected significant deficiencies and IACUC suspensions of animal athties must be reported to APHIS (or, inthe «ase of federal research facilities, to the Head of the Agency sponsoring the research based on §2.37) neither ofthese events occurred at HHMMVAMC.® ORO notes tat although none ofthe incidents set forth in the allegations were reportable to the SECYA under the AWA, ORO ‘oversight cases incluing the above incidents are summarized ina ‘monthly report that is provided to VHA leadership. Furthermore, “acan 238) ate np, tha fate nitreto thle sheet sends asin feng raraing core aloe reported ting ihn 35 buses yb the NUE, hgh heer Oa o ‘sandy esr spony ting at sta an 2 ah tte CUE ng scene trina he nstnl Oia meorsdaton mth he ACG Sak eee Sse ae ape ae {lect stn a repr hn thu emlanton to APS nd ny eer ogee nr tha acy ‘Sezeen 257) stash Cotes salrepet deen tothe hes of eer apr conctg he ser rahe tha to AMI; on (The ao te oer apne cnn he sere sal beeper ol cei tooo bean ttefskty ante thpatng tl crt eecion rate” "tp wan Fl pad verona th vr God ude Agta) a3] wre ak pens ‘poset te ACU and href wert abe othe peter 9231 5237, @ Biter ume cpubae Hunter Holmes McGuire VA Mecical Center May 30,2017 summaries ofthese cases are captured in 2 quarterly and/or annual report sent by the SECVA tothe US. Congrass. (3) summary of corrective actions taken and/or required to address and resolve the issues and to prevent a recurrence. (a)No corrective ations are required, (4) Timeframe for corrective actions (i.e, completed and/or required), (ana (6) Summary of documentation supporting the determination (a) ORO case records 652-0017-A, 652-0020-A, and 652-0021-4; HHMVANIC semiannual program reviews and facility inspections; and the Animal Welfare Act (9 CFR, Chapter |, Subchapter A, Part 2, Subpart oO. (6) The value of recovery or savings: N/A (7) Name and positon of the reviewer: ORO RSAW (Appendix ASI) & Allegation 1b(4). "VAMC lacks racking records of oversight and mismanagement of ‘experimental failures” (1) Method(s) used by ORO to review the allegation (a)Review of facility reports to ORO and OLAW/AAALAG, IACUC minutes, research seve protocol files, and surgical and medical records. (b)Interviews with selected staff regarding specific incidents identified in the medical and surgical records. (2) Determination by ORO regarding the substance ofthe allegation (2) The allegation isnot substantiated. ()TIe facity maintained and was able to produce forthe review team records of adverse events that were reported to ORO and other ‘aencies/organizations. ORO found no evidence that any adverse or ‘other reportable events were recived, but net tracked, by the IACUC. (ORO did identty a numberof other adverse events and protocol Violations that had occurred but found no evidence thatthe IACUC was informed ofthese incidents so that they could be tracked. (See Section 1, Finding 2 and associated footnotes) Page 17 0f 38 Hunter Holmes McGuire VA Medical Center May 30,2017 (3) Summary of corrective actions taken and/or required to address and resolve the issuesand to prevent arecu (2)No corrective actions are required, (4) Timeframe for corrective actions (Le, completed and/or required). (ernya (6) Summary of documentation supporting the determination [a)0R0 case records (P)IACUC minutes, reports to OLAW/AAALAC, ACORPS, and canine records {e)interviews with VMU staff and IACUC members. (6) The value of recovery or savings: N/A (7) Name and position ofthe reviewer: ORO RSAW (Appendic A) h. Allegation 1e. “The Principal Investigator whose repeated botched surgerles on dogs led to revocation oftheir experimentation privieges sil sted as on active hysicion treating veterans at McGuire VAMC." ‘ORO ld not evaluate this allegation as twas determined, In consuitation with O16, ‘ofall ouside the scope of ORO’s purview and area of expertise. ORO nates, however, thatthe complaint submitted to OIG and referred to ORO didnot provide ‘any documentation to support a nexus between the adverse events that occurred In the animal research and the competency and dinical skis ofthe Pl with regard to ‘the treatment of human patients. IV, ADDITIONAL FINDINGS AND REQUIRED ACTIONS In addition to ORO's findings with regard to te allegations referred by O16, ational finings ‘of noncompliance Inleated below were made in conjunction with ORO’s review of the HHMVAMC research studies involving canines. Within 30 days after receipt of this report, HHIMVAMIC must complete the Remedial Action Plan in the Attachment and return it to the (ORO RSAW Team. The plan mus include specific remeslal actions and timely completion dates for each finding as indicated below. Reference: VHA Handbook 1058.01 §5.¢. The VA facility Director must ensure timely {implementation of remedial actions in response to identified noncompliance or as otherwise found warranted by ORO. (1) Except where remediation requires substantial renovation or @ r= Page 18 0f 38 Hunter Holmes McGuire VA Medical Centar ‘May 30,2017 {fiscal expenditure hiring, legal negotiations, or other extenuating circumstances, remedial ‘actions must be completed within 120 calendar days ofter any determination off ‘noncompliance. (2) Where remedial actions cannot be completed in 120 calendar days, the VA faelty Director must provide ORO with an acceptable written justification and an ‘acceptable timeline fr completion. 41, Provisions for Adequate Veterinary Care. Some animal medical records provided insufficient documentation to demonstrate if {dogs with health problems were consistently evaluated by a veterinarian, consistently received appropriate care, or were appropriately observed for siens of health problems. (1) ORO noted that several dogs had surgery-elated heath ssues but animal ‘medical records did not document or inconsistently documented thatthe dogs Were evaluated by a veterinarian to ensure that accurate dlagnoses and appropriate treatment plans were developed and followed. In someinstances, animal medical records didnot contain sufficient details to determine ifthe animals recelved appropriate treatment, and treatment outcomes were not consistently documented. Specific examples included: |. Dog 5945 (protocol 02235) developed subcutaneous emphysema [air Under the skin) following a protocol-related surgery on January 5, 2017, Entries in the medial ecard, which described an evaluation and a plan to menitor the condition, were made by the Principal Investigator (P), but did ‘not document whether the VMC was consulted to evaluate the animal or provide guidance regarding diagnosis or treatment. lL Dog $945 (protocol 02235) also developed poor posture, depressed attitude and an abnormal capillary rfl time (o2 seconds) postoperatively ‘on January 26, 2017. The medical record did not document adtional postoperative supportive treatments or care, and didnot Indicate if the YMC was consulted to evaluate the animal or provide guidance regarding diagnosis or treatment. Ti. Dog 5956 (protacol 02235) developed lethargy, signs of dehydration, and ‘abnormal nasal discharge postoperatively on November 1, 2016, The medial record incieated that supportive care such a¢intsuens (IM) fluids and antibiotics was provided; however, it did not document whether the VMC was consulted to evaluate the animal or provide guidance regarding clagnosis or treatment. |v, Numerous entries in dog veterinary mesical records referenced re-suturing incisions, draining seromas or other procedures related to surgical implant complications. Medica records dié not consistently document f the VMC VA @ Wikiune i sre Page 19 of 38 Hunter Holmes MeGuire VA Medical Center May 30,2017 2) \was consulted to evaluate the animals and, in some cases, the records Jacked sufficiont detail to determine who performed the procedure, what ‘nesthetics/anslgesis were provided, or how the wound closure was accomplished. Animal medical records did not document or inconsistently documented that ‘dogs received appropriate supportive cae, including preoperative medications, intraoperative monitoring/support, and observations for signs of health problems. Ww, Protocol 02002 stated thatthe analgesic buprenorphine would be given to ddogsas a preoperative medication for surgical procedures. However, this drug was not consistently recorded as preoperative medication in the intraoperative and veterinary medical records, soit was not possible to

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