The Honorable Henry J. Kerner Special Counsel U.S. Office of Special Counsel 1730 M Street, NW, Suite 300 Washington, DC 20036 August 14, 2018. RE: OSC File No. DI-16-1945/DI-17-1294. Special Counsel Henry J. Kerner: I am responding to the Department of Veterans Affairs, former Chief of Staff’s letter, dated July 20, 2017, and to the letter of the Department of Veterans Affairs, Executive in Charge, dated January 4, 2018. In her letter, the Executive in Charge stated that the report from the Office of the Medical Inspector (OMI) partially substantiated allegation # 3 but not allegations # 1 and # 2. This statement is clearly incorrect and the reason for the Executive in Charge’s letter should be investigated since the Report corroborated all the allegations, despite the misleading summary of the OMI Report. In my opinion, contrary to the conclusion of the OMI’s Report, and Department of Veterans Affairs, former Chief of Staff’s and Executive in Charge’s letters, the violations of VHA policy are a substantial danger to Veterans and public health at the Veterans Affairs San Diego Healthcare System (VASDHS). I would like to emphasize that: 1] The VASDHS’ medical and non-medical personnel provides excellent care to Veterans, and it is an honor and a pleasure to work with them. 2] My colleagues in Gastroenterology, Medicine, Radiology, Surgery, and Pathology are highly qualified professionals . Many of these individuals are national experts in their medical fields. 3] The VASDHS’ medical and non-medical personnel have high ethical standards. • Introduction: In the first interview by phone, the OMI asked me how qualified I was in clinical research in a scale from 0 to 10. Only a biased group needs to ask that question. In contrast, a competent Auditor will find out what are the facts without preconceived opinions. In the same interview, the OMI told me that if I did not provide all the specifics of the Chief of Gastroenterology, Dr. Clinical Research study (number, title, patients involved, etc), they would not be able to analyze the complaints. I told the OMI that I did not have access to this information. Some ethics experts would call the OMI’s demand a ‘deliberate indifference’. I did not ask the OMI group about their qualifications since it was obvious from their questions that they were quite unexperienced in Standards of Care (SOC) and Clinical Research in general, and particularly, in liver diseases. Subsequently, I found that they were biased in almost all aspects of their Report. I had not submitted any complaint to the VASDHS, the VA Central Office or the US Of?ce of Special Counsel (OSC) before. However, the potential unethical, and illegal clinical activities affecting Veterans? safety, and the reprisals against Whistleblowers, prompted me to issue disclosures in June 2013 to the Director, Division of Gastroenterology, at the University of California, San Diego (UCSD) (the affiliate academic Institution), who appropriately forwarded my allegations to the Chief of Medicine - .D.- and to the Chairman of Medicine at UCSD and a VASDHS Physician- -- From: Date: Fri, Jun 7, 2013 at 5:34 PM Subject: RE: - To3-- Cc: Dear Thank you for your letter. Given the nature of the allegations that you have raised, and the fact that they involve VA personnel, patients, policies, etc. Having received your letter, I am now must move forward with having the issues that you have raised addressed. With this in mind, I have copied my supervisor and Dr- VA supervisor on the letter. We will discuss how to proceed, and someone will be back in touch with you in due course. Best regards and in August, November, and December 2016 to the Chief of Medicine the Chief of Staff -) (in person), and the Medical Director I as well as to the OSC. Frow-? Sent: Tuesday, August 02, 2016 4:55 PM Subject: Violation of Whistleblower Act and Inappropriate Professional Conduct Dr.__.nd Dr--l- Please find attached a letter expressing my concerns about inappropriate professional conduct regarding patients, staff and IT. Sincerely, None of the allegations were investigated in 2013 by_ --D. or by the Chairman of Medicine at UCSD and a VASDHS However, proceeded with harassing Dr. - (Whistleblower of Allegation 1), and me by postponing for several months the transfer of NIH Subawards expelled by the VASDHS (see Reprisals below). In violation of the UCSD Policy, Dr. denied my rights as a Professor of Medicine to submit grant proposals outside UCSD (within UCSD guidelines) by not responding to 20 emails in 6 months. In addition, Dr. - - found it his duty to call Dr. - - and yell at her (after hours and on her cell-phone), about my ?potential? Con?ict of Commitment at UCSD (even though had just submitted a letter for my promotion at UCSD stating that my commitment to UCSD had been outstanding). We believe, that the expulsion of Dr. - - and my NIH grants at the VASDHS, and Dr. Dillmann?s holding-off of the Whistleblowers? NIH grants, and the yelling at Dr. - - were part of a retaliatory ?program? between the leadership (see below) and some individuals at UCSD. The pertinent UCSD Committees found Dr. and my research activities to be ethical and in compliance with UCSD policy. The Whistleblowers? allegations of civil and criminal violations at the VASDHS were either superficially analyzed or not investigated in 2016 by the leadership and in 2017 by the OMI. This overt disregard of the potential significance of these allegations can only be the result of ineptitude and/or corruption among the leadership and the OMI. Obviously, this reporting has no ulterior benefits to me since it is time-consuming, and has already exposed me to retaliatory actions by Dr. - - the leadership, and the Chairman of Medicine, UCSD, in violation of the Federal Whistleblower Protection Act. Other Whistleblowers at the VASDHS have also been retaliated against by and/or the leadership (see below). 0 Background for the Public Health Violations and Abuse of Power at the VASDHS. Dr. - - and others among the leadership have created a hostile working environment for the Physicians, Nurses, and Administrative Staff at the VASDHS for several years. The following are a few representative examples of the hostile work environment, which contributes to the abuses to Veterans, and in turn, increases the hostile work environment for those who have witnessed those abuses to Veterans: A few years ago, the GI Section Administrative Assistant, - (a Veteran and a patient at the VASDHS) collapsed, and a ?Code Blue? was called. She was taken to the Emergency Department for assessment and treatment. She returned several hours later to the GI Section looking exhausted, and confused. She said that she could not go home because Dr. - had prevented her from leaving due to ?critical deadlines?. This action appears to be an illegal and inhumane practice and re?ects the insensitivity of Dr. - towards his staff and Veterans. Ms - was abused and forced to work often 2-4 additional hours per day for more than 1 year (without compensation and at times without authorization for annual leave -which is unethical and unlawful) by Dr. and by the Medicine Service Administrator, Ms. Finally, due to the significant emotional stress she suffered, Ms. - stopped working and she was forced to resign by the Director, - - II, who threatened, otherwise, to terminate her position despite her excellent performance history for a decade, and the clear emotional abuse that she had been subjected at the VASDHS. This seems to be a violation of the Federal Whistleblower Protection Act or Abuse of Power since Ms. - testi?ed against Dr. - Ms. and the leadership to the OMI and the OSC. Ms. physician request that she be transferred to another VASDHS area to enable a better control of her disability (away from the co-abusers, Dr. - and Ms. was rejected by the leadership. Where is the sensitivity of the VASDHS towards Ms. a disabled Veteran and a patient at the VASDHS at the time that Dr. - - forced her to resign? When Ms. - told Dr. - - that the OSC was analyzing the VASDHS Whistleblowers? complaints, Dr. - - said I don?t care about the This is a major problem with the VA system; the OSC and OMI investigations have no signi?cant and timely consequences for those responsible for the abuses. The VA system continues to abuse the Whistleblowers, and has created ?a culture of fear and retaliation?. The Chief of Medicine, -, the Chief of Staff, - . In 2013-14, Dr. - proposed to expose pregnant Veterans and their fetuses to abdominal Director, -- --. are responsible for these violations. X-rays in his Clinical Research, in violation of Code of Federal Regulations, Title 45, Part 46 since the study does not provide any benefit to the mothers or the fetuses. This type of proposed research is barbaric and reminiscent of those described in the Nuremberg Trials after the Second World War. This violation (although not executed due to the strong opposition of Whistleblower Dr. - during the review of the protocol) was covered-up by the Associate Chief of Staff, Research Development, - and the Compliance Officer, Dr. (see Allegation 1). Indeed, the VHA Handbook 1201.1; 8 (2) states that Studies disapproved for ethical considerations may not be carried out in VA space, or with VA resources, even if the project is funded by another agency.? Drs. and - have violated for many years the VHA Handbook 1201.1; 8 (2). This is a gross disregard of Federal ethical principles at the VASDHS Research Service. This violation of Federal ethical principles has been reported to the leadership and the OMI on several occasions from 2013 to 2017. In addition, there were many civil and criminal violations of human rights in the conduct of this Clinical Research study (see Allegation 1), as described in my letter of June 2013 to the Chief of GI, UCSD, in my letters to the leadership in August, November, and December 2016, and to the OMI in 2017 (see above). The leadership and the OMI have neither acknowledged nor reported these gross violations in human research. Therefore, the Associate Chief of Staff, Research Development, -., the Compliance Officer, Dr. the Chief of Medicine, the Chief of Staff, - and the Director, - I - .- are complicit in the civil and criminal violations 0 uman rights. A few years ago, the GI Section Case Manager told Dr. - that a newly recruited physician had an abusive behavior towards patients and nursing staff at another San Diego Hospital, Dr. replied in an angry tone don?t give a if he abuses patients or nurses, I just care that the job is done.? Because of Dr. - behavior, the Case Manager requested to be moved to the Nursing Service and subsequently to the VASDHS at another location. In 2017, a Clinical Research Coordinator mentioned to Dr. - (in his of?ce) that she had problems with the compliance of some Veterans enrolled in a Clinical Study. replied that ?all Veterans are This was overheard by Ms. - (a Veteran) from the adjacent Administrative Assistant?s Of?ce. Ms. - provided this information to me and Dr. - - the same day. A GI Staff Physician, - I. (not a Veteran) was coerced by Dr. - and the Chief of Medicine, I to have a testing at the VASDHS. This appears to be in violation of the VHA Handbook 5019/1, Part II (2) (August 3, 2017) Policies. ?If the employee?s position does not have properly established medical standards or physical requirements or there is no basis to order the examination based on a ?job related? or ?business necessity? then there is no regulatory authority to order a fitness-for-duty, examination, or assessment. In addition, and in violation of HIPAA (Public Law 104-191), Drs. - and without a written consent, accessed the Report of Dr. - (see representative email below). According to the training that we receive at the VASDHS employee that knowingly violates the Privacy Act HIPAA (42 U. S. C. ?1320d-6) can be ?ned not more than $50,000, imprisoned not more than 1 year, or From --I Sent: Monday, April 16, 2012 3:34 PM -- Subject: RE: - As I mentioned to you earlier, the report of your tests did not identify any problem. Drs. - and - - are not entitled to engage in activities that violate VHA Policy to achieve their goal of terminating a Physican?s position. Dr. substantiated this violation in writing to Ms. Siobhan Smith Bradley, OSC . The Chief of Medicine, II the Chief of Staff, - - and the Director, -- --I. are responsible for these violations. 0 In November 2017, during a lecture at the VASDHS by a Nutritionist about the difficulties in treating overweight Veterans with diets, Dr. - stated that to control their caloric intake we should place these [overweight] Veterans in a Concentration Camp?. This statement was witnessed by the GI Nurse Practitioner, the Hepatitis Pharmacist, and three physicians. This hate speech creates a hostile work environment in violation of VHA Rules and Regulations. . As I mentioned to the OMI and the leadership (but apparently, the OMI and the leadership believed that it was irrelevant), the neglect of Veterans? rights and safety by Dr. - is itomized by his ?order? to Dr. a GI UCSDNASDHS Physican, suffering from an- and having to ?get his here, and perform GI oscopies on severa erans. con ras ASDHS, the UCSD Division allowed Dr. -- to take sick leave at the affiliate UCSD Hospital. Dr. - action added an unacceptable, excessive risk to the Veterans undergoing the procedures. This complaint has been substantiated by Ms. - and can be substantiated by the Chief, GI Endoscopy (who discussed this issue with me the same dayThis example alone illustrates the extremely low respect for the Veterans by some individuals at the VASDHS. However, neither the Chief of Medicine, Chief of Staff, and Director, nor the OMI investigated this grossly unprofessional episode. This was unequivocal medical malpractice and an abuse of power. The Chief of Medicine, the Chief of Staff, - - and the Director, -- a are responsible for these violations. . Although no caregiver at the VA System ?can perform any invasive procedures [like Endoscopies] without an approved and current ACLS certi?cate?, Dr. - - has allowed GI Physicians to perform Endoscopies without a current ACLS certificate in violation of the VHA policy. (witnesses: Ms. - and the two former Clinical Nurse Managers, Outpatient Procedures). These Physicians just followed Dr. - - directives, and they are not responsible for the violations of VHA Rules and Regulations. The Chief of Medicine, .D., the Chief of Staff, - - and the Director, -- --D. are responsible for these violations. . Although, no caregiver at the VA System ?can perform any clinical activities without an approved IT access?, Dr. - has allowed violations of this VHA policy in many cases over many years. Further, Dr. - - has facilitated violations of this VHA policy (and a violation of medical practice in the State of California) by providing his own log-in use/password to the Endoscopy Computers (against the VHA Rule Regulations) to Per-Diem (Fee Basis) Physicians who performed the procedures without having their own access (witnesses: Ms. and the two former Clinical Nurse Managers, Outpatient Procedures). These Physicians just followed Dr. - directives, and they are not responsible for the violations of VHA Rules and Regulations (see emails below). From:- B. Sent: Monday, April 10, 2017 9:04 AM To: - Subject: RE: Case log - please credit Dr with one EGD with no biopsy for payment on Fee basis, to be paid next time cards are due, thanks Original From: Sent: Sunday, April 09, 2017 10:13 AM Subject: RE: Case log Hi- just performed the following case today while on call with Unfortunately, my Provation log-in no longer works (we tried to log in today, but no luck) so the case will be listed under Dr. 0 Dr. - - ?coerced? a former GI Physician to perform Per-Diem (Fee Basis) Endoscopies on Saturdays, although this physician was not approved for Per-Diem work and couldn?t be paid for her Per-Diem work. Thus, Dr. - and Ms. falsi?ed this physician?s timecard adding ?research? hours to cover clinical for the Per-Diem payments (witness: Ms. This Physician just followed Dr. - directives, and she is not responsible for the violations of VHA Rules and Regulations. Complaints by many VASDHS employees about the hostile work environment created by Dr. - - and others in the leadership have been provided in writing and in depositions to Dr. Dr. and the OMI- However, on February 14, 2016, the Director, Dr. -- stated in a memorandum to me that ?Based on the evidence presented, were unaple to substantiate any behavior that was suf?ciently severe and pervasive to create a hostile work environment. As such. this matter is considered administratively closed.? I wonder what would be suf?ciently severe and pervasive for the Director, Dr.- - Apparently, it is not sufficiently severe and pervasive to create a hostile work environment to 1] have thousands of HIPAA and IT violations; 2] propose exposinq pregnant Veterans and their fetuses to abdominal Lravs in Clinical Resear?; 3] force a physician with an acute eve iniurv, and having severe pain and limited vision, to perform GI Endoscopies 4] falsify CPRS and Endoscopy records 5] propose poor and dangerous clinical practices; 5] have non-clinical personnel closinq clinical consults; 6] selectively apply and enforced rules aqainst Whistleblowers; 7] selectively apply CPRS auditing and retaliation aqainst a Whistleblower; 8] selectively force testing of a ?dissident? physician and 9] perform il?gal Clinical Research with manv violations of human riqhts. Compared to this memorandum, one email containing the already disclosed allegations from Dr. was sufficiently ?severe and pervasive? to cause a verbal complaint of ?general stress? by Dr. the W, leading to a fact-finding inquiry that resulted in Whistleblower Dr. - - termina Ion 8? leadership on June 2018. This doesn?t appear to be an equal application of any policy. What it appears to be is Whistleblower retaliation (see below). At the VASDHS the original transgressions and the cover-up are both remarkable. The Chief of Medicine II the Chief of Staff, and the Director, - I - i are responsible for these violations. • Allegation # 3. Violation of VHA Privacy and HIPAA Rules of Behavior Policies & Inappropriate Closing of Medical Consults Without a Clinical Review. The OMI substantiated “that the Chief, GI, directed the Program Specialist and some research assistants to close consults while being logged on the computer under the Chief, GI’s, network access, thereby violating VHA information security policy.” The OMI’s Comments to the Medical Center include the following: “…the seriousness and inappropriateness of sharing VA staff members’ passwords to gain access to VA computers. The VA Table of Penalties list punishments ranging from admonishment to removal, depending on the stated offense.” “…the Chief, GI’s, persistent violation of VHA Privacy and HIPAA Rules of Behavior Policies by allowing staff members to use his password to gain access to VA computer systems.” “The Chief, GI, admitted that he would log on to the network ….. for his GI fellows and research asssistants, because it would take months for the Medical Center to provide them with computer access.” My Comments : Dr. violations have been pervasive for several years. They have occurred regularly, involving numerous VASDHS’ employees, who lacked access to VA computers and/or VA-CPRS (electronic medical records). This was acknowledged by Dr. the Administrative Assistant, Ms. the Program Specialist and five research assistants. The former GI Nurse Practitioner, my two Clinical Research Coordinators, and I have also witnessed multiple IT and HIPAA violations by Dr. These witnesses substantiated that Dr. ordered them “to close consults under his name [Dr. and in same cases, this occurred simultaneously on several computers, with all employees using Dr. Ho’s, login information”. Violations of VHA Privacy and HIPAA Rules of Behavior by Dr. were routine. Apparently, the VASDHS’ leadership and the OMI’s Report accepts that Dr. is above the VHA Rules and Regulations. They seem to believe that VHA IT and Privacy Act HIPAA (42 U.S.C. §1320d-6) violations could be tolerated if there is a ‘justification’ or if it is VASDHS’ leadership perpetrating the violations. This type of computer access by a group has been practiced whenever Dr. felt that violating VHA Rules and Regulations was needed to achieve a ‘good rate’ of consult closing, or to facilitate his ‘work preferences’. Thus, although our motto is Veterans First, the Veterans come ‘last’ and Dr. and the VASDHS’ leadership comes ‘first’. Also, forcing employees to perform activities that violate VHA Rules and Regulations, is an additional violation of VHA Rules of Behavior Policies since it establishes a hostile work enviroment at the VASDHS for those employees, and for other employees that witnessed or learned about those violations. As a ‘justification’ to the the inappropriate closing of Consults by the Administrative Assistants, the OMI’s Report states that “…on July 2, 2015, [Ms. received a certificate of completion for the training “What Every VA Clinician & Resident Needs to Know About Consults”. This is not a justification but rather an enablement of actions by the VASDHS’ leadership that undermine any semblance of medical care that could have been received by these patients. This is in effect the OMI supporting the strategic VA policy violations and illegal medical practices of the VASDHS’ leadership. These violations occurred because the VASDHS’ leadership ‘needs’ to achieve sufficient ‘numbers’ that are not always measurements of care received by patients. This strategic VASDHS’ leadership policy violations are an inappropriate response to the multiple Government Accountability Office (GAO) reports faulting the VA for inadequate management of Consults (see below). If this wasn’t such a serious issue, this ‘loophole’ created by the VASDHS’ leadership and the OMI , including the title of the clinical training for Aministrative Assistants would be laughable. Examples of the systematic efforts to involve many Administrative Assistants (with a ?sham? clinical training) to Close Consults at the VASDHS are shown below. From: -- Sent: Tuesday, April 1 017 1:05 PM To: [several Administrative Assistants]; Importance: High From: Sent: Tuesday, April 18, 2017 9:Subject: ay 5 INPATIENT Open Consults Importance: High Good Day, You have been identified the responsible person on a consult in the attachment or as either a Service Chief or Administrative Of?cer with oversite over consults. Should any consults fall under your responsibility please take appropriate action. Please review today?s attached "Inpatient Open consult report?. Currently there are 30D AND 600 (16) Inpatient Consults for review that are 27 days, and (28) Inpatient Consults >2 days and 7 daysTotals 44 R/s, Management and Program Analyst From: Sent: Thursday, March 26, 2015 4:38 AM MD (Portland) Subject: Consult Closure Training -- VISN 22 (Additional Session) When: Tuesday, March 31, 2015 5:00 PM (UTC-05200) Eastern Time (US Canada). Where: dial 1-855-767-1051 83317462 Clinic Consult Closure Mandate and Training Good Afternoon, There have been multiple GAO reports faulting the VA for inadequate mmgement of Consults. Some of the recurring Consult challenges include (1) Failure to triage Consults in a timely manner, (2) Failure to link Consult Notes to the appropriate Consult, (3) Failure to follow up on No-Shows, (4) Lack of a standardized process for discontinuing Consults, and (5) Lack of a standardized process for Future Care. The VA has been instructed to standardize Consult Management processes and to train staff in accordance with these improvements. (Portland) will be conducting customized training for the appropriate representatives of your VISN and associated Sites. Since this training is specifically developed for your VISN and Sites, please make plans to attend personally. If you cannot attend, provide VISN/Site representatives who can attend in your absence. The number of customized trainings makes the rescheduling of sessions challenging. Thanks so much for your attention to this invitation and for your cooperation in this training campaign. You can contact me with questions and requests for clarification. Training Slides and Leadership Slides can be accessed in the Consult Closure Campaign folder on the Consult Management SharePoint site. The Consult Switchboard has real-time Consult Management data. Dr. The MITRE Corporation --------------------------------------------------------------------------------------------------- ------------------------------------------------------ The Director, Dr. has endorsed the ‘sham’ clinical training for Administrative Assistants. On February 22, 2017, Dr. sent an email to many Administrative Assistants urging them to close Consults (see below). I have reported to Dr. the abuses in closing Consults in August 2016 but I did not know that he was directing this massive closing of Charts by non-medical personnel. Indeed, Dr. gave a presentation to many Administrative Assistants on how to close Consults. --------------------------------------------------------------------------------------------------------------------------------------------From: VHASDC Sent: Wednesday, February 22, 2017 4:56 PM To: …[several Administrative Assistants];…………………………………………………. Subject: RE: San Diego Consults Backlog Update 2/13/2017 Attachments: Older than 180 Days from approp date.xsx I mentioned at morning report that we have a significant number of consults more than 180 days old from the clinically indicated date. Please pay particular attention to the review of these particular consult requests (a redacted list is attached) and closing them or assuring that there is action taken. It is clear from a cursory review that many (most?) are obsolete and should be discontinued. …………………………………………………………………………………………………………………………. How is training an Administrative Assistant as a ‘VA Clinician’ in just a few hours possible and appropriate for closing consults at the VASDHS ? Ms. has stated to the OMI that in may instances Veterans with serious medical issues were lost to follow-up and that she was unable to decide what course of action was appropriate ethically and medically. Indeed, Ms. Siobhan Smith Bradley, Attorney, Disclosure Unit, US Office of Special Counsel, has stated that “….the VHA Directive 1232 (1) 5.g.(6) requires the facility Medical Director to ensure that consults are not discontinued without a clinical review.” The OSC position is legally incompatible with the position of the OMI, former Chief of Staff, and Executive in Charge, Department of Veterans Affairs; Dr. Dr. Dr. and Dr. VASDHS, since Ms. claims that many of the consults lacked a clinical review before she closes them (see an example below). -------------------------------------------------------------------------------------------------------------------------------------------From: To: Fri 4/28/2017, 6:39 PM Dr. told me the evening of 4/27/17 to admin close the consults he marked. I checked off each one he directed me to close. There were two, I had no clue what to do with – one was a liver patient of Dr. and the other, there was no note or anything attached to the consult. I informed Dr. that once I admin close these, the primary care physician who is caring for these patients will not be flagged or notified of the patient not having a procedure completed – he stated that he had no clue about that. I informed him that a lot of these should be discontinued so that they are returned to the PCP for follow-up care. The claim by Ms. that she (and many other Adminstrative Assistants) was ordered directly or indirectly by Dr. Dr. and Dr. to close consults without a clinical review, has not been investigated by the OMI. It is remarkable that the OMI have neglected to investigate this issue that may have negatively impacted the care of thousands of Veterans at the VASDHS. Further, by using Administrative Assistants with ‘sham’ or no clinical training to close Consults, the VASDHS may have violated the contracts it has had with patients and Medical Insurance Companies (including Medicare). If this correct, the VASDHS may have committed fraud. The VASDHS’ ‘leadership’ and the OMI are responsible and complicit, respectively, for these violations. The unethical, and probably criminal, closing of consults by non-medical personnel at the VASDHS, may be a bigger scandal that the scheduling fiasco at the Phoenix VA. The OMI asked me if I knew that any Veteran has died as a consequence of the (illegal) closing of Consults by non-medical personnel. I answered that it was likely but that this sytematic violation of Veterans rights should be investigated by the FBI as it happened in the Phoenix VA. The OMI’s position is, apparently, that the training of non-medical personnel as a ‘VA Clinician’ for just a few hours is adequate to make an Administrative Assistant able to perform a clinical review, and protect the safety of the Veterans. In my opinion , the position of the OMI, Dr. Dr. Dr. and Dr. regarding the ability of the Administrative Assistants to perform a clinical review (needed for closing the consults), after training for just a few hours on “What Every VA Clinician & Resident Needs to Know About Consults” is unethical and probably criminal. This is evidence of both a gross bias and ineptitute by the OMI. Even if they were correct in their position, then the OMI , and Drs. and have neglected to acknowledge that a lack of certificate of completion for the training “What Every VA Clinician & Resident Needs to Know About Consults” of several other non-medical personnel closing consults (according to the OMI …” the Program Specialist and some research assistants”…) under the log-in of Dr. was a severe violation of VHA Privacy and HIPAA Rules of Behavior Policies. The OMI recommended additional training of Dr. This seems to be a trivial and illogical diversion since all the Physicians at the VASDHS, including Drs. and have had yearly training in VHA Privacy and HIPAA Rules of Behavior Policies (VA Handbook 6500, Information Security Program). Obviously, after 35 years of practicing academic medicine, and receiving training on these issues at the VA Medical Centers in San Francisco, Minneapolis, and San Diego, additional training for Dr. seems surperfluous. The same applies for the training of Drs. and Violations of Federal Acts are not solved by ‘more of the same’ training and they need to be investigated by an independent group. The OMI and the VASDHS’ leadership appear to be complicit in their actions and inactions. Why did the OMI’s Report minimize these violations, and why has the Compliance Officer, Dr. the Chief, Medicine, the Chief of Staff, and the Medical Director , VASDHS, ignored these allegations ? What is the significance of these violations ? Physicians at the VASDHS confirm their training by signing “ 2. Specific Rules of Behavior; e] I understand that such unauthorized attempts or acts [Violation of VHA Privacy and HIPAA Rules of Behavior Policies] may result in disciplinary or other adverse action, as well as criminal or civil penalties.” Implementation of the Health Insurance Portability and Accountability Act (HIPAA) (Public Law 104-191) raises numerous questions in how business will be performed within the various parts of the Department of Veterans Affairs. The Office of General Counsel provides advice to all organizations within the VA about their legal obligations. One of the Administrative Assistants commented that Dr. told them “…you are going to help your Section Chiefs get everything clean out, number low, and nothing old left pending… The rule then became, any Consult remaining open after 90 days was to be closed…” Ms. commented that “… [there was] no [clinical] review by anyone. I along with [non-clinical] research staff closed over 300 [Consults] at the beginning… weekly or bi-weekly there were 25-50 [Consults]. But no one checked after me or any other Administrative closer… They emailed the list to me [Dr. and [Ms.] [ I would check for appointments, completed procedures. [Dr. would tell me to just close them anyway.” Thus, at the VASDHS just one Administrative Assistant had been closing Consults without a clinical review at a rate of ~ 1,000 per year. These are all likely violations of VHA Rules & Regulations, HIPPA, fraud, and medical malpractice. Given that a similar rate of closing Consults is expected for many Medical Sections, it is likely that many VASDHS’ Administrative Assistants had been closing each year dozens of thousands of Consults without a clinical review. This (mal)practice has been in effect at the VASDHS for at least a few years. It is remarkable that the Compliance Officer, Dr. the VASDHS’ leadership, the OMI investigators, and the former Chief of Staff and the Executive in Charge, Department of Veterans Affairs, found that thousands of HIPAA violations (a Federal Act) are not serious enough to substantiate the complaints. Many non-clinically trained research assistants, and administrators at the VASDHS have had illegal access to thousands of Protected Health Information by entering CPRS Veterans information. [“…If a hospital employee is allowed to have …., unimpeded access to patients’ medical records, where such access is not necessary for the hospital employee to do his job, the hospital is not applying the minimum necessary standard. Therefore, any incidental use … that results from this practice … would be an unlawful use or … under the Privacy Rule]. 45 CFR 164.502(a)(1)(iii). In summary, the closing of Consults without a clinical review by non-medical personnel appears to be ‘endemic’ at the VASDHS given that many Administrative Assistants received the training “What Every VA Clinician & Resident Needs to Know About Consults” , and were directly or indirectly encouraged to close Consults by Dr. , Director, VASDHS. Thus, Dr. appears to have violated the VHA Directive 1232 (1) 5.g.(6) that requires the facility Medical Director to ensure that consults are not discontinued without a clinical review. Protected Health Information. The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information (PHI)”. “Individually identifiable health information” is information, including demographic data, that relates to: • the individual’s past, present or future physical or mental health or condition, • the provision of health care to the individual, or • the past, present, or future payment for the provision of health care to the individual, and that identifies the individual, or for which there is a reasonable basis to believe it can be used to identify the individual, individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number). In this context, the US Department of Health & Human Services (December 3, 2002) has established that: “A breach is … an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of the protected health information. An incidental use or disclosure is a secondary use or disclosure that cannot reasonably be prevented, is limited in nature, and that occurs as a result of another use … that is permitted by the Rule. However, an incidental use … is not permitted if it is a by-product of an underlying use … which violates the Privacy Rule. 45 CFR 164.502(a)(1)(iii)” [‘The fruit of the poisonous tree’]. “The minimum necessary standard requires that a covered entity limits who within the entity has access to protected health information, based on who needs access to perform their job duties. If a hospital employee is allowed to have …., unimpeded access to patients’ medical records, where such access is not necessary for the hospital employee to do his job, the hospital is not applying the minimum necessary standard. Therefore, any incidental use that results from this practice would be an unlawful use or under the Privacy Rule. 45 CFR [?The fruit of the poisonous tree?]. Thus, it seems clear that the violations of HIPAA by Dr. - and the complicit actions/inactions by Drs. - - and (Medical Investigator, OMI) are also violations of VHA Rules and Regulations. Further, these violations may be considered as falsifying the medical records of thousands of Veterans, as Dr. - - through his non-medical personnel, whom do not have authorized access to CPRS, terminated unresolved consults. This issue was not addressed by the OMI (except, and in error, for the GI Endoscopy Consults), despite the recent VA-OIG Investigation of an employee at the VA Medical Center in Augusta, who was sentenced to federal prison for violations, by the United States District Court Judge, in Augusta, Georgia. According to the training that we receive at the VASDHS an employee that knowingly violates the Privacy Act HIPAA (42 U. S. C. ?1320d?6) can be ?ned not more than $50,000, imprisoned not more than 1 year, or The OMI, and Chief of Staff, Department of Veterans Affairs, and the leadership are responsible for disregarding violations of the Federal Act 42 U.S.C. ?1320d?6. Dr. ?laims that ?he had to violate? VHA Privacy and HIPAA Rules of Behavior Policies since he had ?a nee cose the consults? keeping open several computers (under his log-in) ?for coworkers [without authorized acces to VASDHS to close Consults? . As a legal precedent for Dr. - HIPAA violations, a physician at another US Hospital, who had illegally accessed patient records over 300 times (most likely fewer than Dr. - cumulative violations), was found guilty after having been prosecuted for just four of the 300 cases. The physician stated: didn?t do anything wrong?; I never sold the information or told anyone about it?; didn?t know that was a crime?. On appeal, in 2017 the Ninth Circuit Court held that the plain text of the statute does not limit its application to people who knew their actions were illegal. Rather, the court stated, ?the misdemeanor applies to defendants who knowingly obtained individually identi?able health information relating to an individual, and obtained that information in violation of HIPAA. The Court went on to say that legislative history indicates that Congress intended broadly to apply this misdemeanor criminal penalty, and that ?our conclusion is supported by Congress' decision not to require willfulness as an element of the crime.? The court refused to dismiss the case, and the Physician?s conviction stood. The health system ended up paying over $800,000 in civil ?nes related to this case. Dr. - persistent (for several years), extensive (thousands of Veterans? CPRS [electronic medical records]), and widespread violations of VHA Privacy and HIPAA Rules of Behavior Policies, and the irregulaties in the closing of consults (involving dozens of VA employees without authorized access) are a substantial danger to Veterans? safety and public health at the VASDHS. The leadership and the OMI have neither acknowledged nor reported these civil and criminal violations. Although the OMI and the VASDHS leadership found that the closing of GI Endoscopy Consults by non- medical personnel were performed according to the VA Rules and Regulations this is not the opinion of the OSC . Ms. Siobhan Smith Bradley, Attorney, Disclosure Unit, US Of?ce of Special Counsel, has stated that VHA Directive 1232 (1) requires the facility Medical Director to ensure that consults are not discontinued without a clinical review.? Because many of these GI Endoscopy Consults were closed by Mr. a former GI Administrator, he was unable to perform the indispensable ?clinical review? according to the OSC, in violation of the VHA Directive 1232 (1) The Compliance Of?cer, - - the Chief of Staff, and the Director, -- --I are responsible for these violations. • Allegation # 2. Poor Clinical Practices Proposed by Dr. VASDHS’ Leadership. and Accepted by the a ] Liver Transplantation: The OMI substantiated the complaints. “The Chief, GI, told us that ‘active alcoholics are not approved for transplants” . However, he went to say “I prefer that we refer patients and let the VACO make the decision [of whether they’re eligible or not]; they are the experts, not me.” “ the GI NP …. [said] that the referral packet for approval by VACO, [is] a process that can take 2 to 3 months.” My Comments: On April 4, 2017, I submitted to the OMI evidences that Dr. was coercing the GI NP and GI Fellows to submit referral packets for liver transplantation that had unequivocal and overt exclusionary criteria. The GI NP substantiated that Dr asked her to submit requests for patients who “ clearly did not meet transplant criteria” , and she commented that “it’s a waste of resources and time knowing they won’t qualify”. For Dr. a Board Certified Gastroenterologist with 35 years of academic clinical practice to argue that he doesn’t know the exclusionary criteria for liver transplantation is not believeable. This is clearly, another maneuver to make numbers ‘look good’ for the VASDHS’ leadership, at the expense of the Veterans, their relatives and friends, the GI NP, the GI Fellows, and for the VACO Reviewers. In addition, Dr. is coercing the Liver Group under my direction to do ‘busy work’ , abusing the Veterans by requesting several, unnecesary, and potentially risky invasive procedures (needed for the transplantation assessment process) , creating false expectations among Veterans (an emotional abuse), and losing credibility among the VACO Reviewers. This is a poor and wasteful clinical practice and an abuse of power. What is the point for the OMI to interview under oath the current GI NP and then not accept her substantiation of the inappropriate referal for liver transplantation. In addition, I have submitted documentation substantiating the ‘order’ by Dr. to submit inappropriate packets to the VACO for liver transplantation. It is not relevant that the former GI NP did not want to be interviewed by the OMI [she was afraid of the ‘expected’ reprisals by Dr. and leadership at the VASDHS]. The former GI NP has also substantiated these issues telephonically to Ms. Siobhan Smith Bradley, OSC. Dr. violations of SOC are a substantial danger to Veterans and public health at the VASDHS and an abuse of power. The VASDHS’ leadership and the OMI have neither acknowledged nor reported these violations of medical practice. The Chief of Medicine, ., the Chief of Staff, . are responsible for these violations. , and the Director, b] Endoscopy: The OMI substantiated the complaints. “The GI NP stated that when she questioned the Chief, GI, about EGDs (‘Upper Endoscopy’) for ChildPugh A patients, he became upset and sent an email in December 2015 to providers in primary care and HCV clinic that reads “if a patient has [Child-Pugh class] A cirrhosis [is] asymptomatic and has been cured from [HCV], I would not recommend [esophageal varices] screening…….” My Comments : The GI NP asked my opinion about Dr. - - statement, and I told her that it was clearly a dangerous departure from SOC for cirrhotic patients and that he was putting Veterans at risk. Both the GI NP and the Nurse Manager substantiated my complaints about Dr. - departure from SOC EGDs for Child-Pugh A (compensated) cirrhotic Veterans, and from all the US guidelines, including those from the VACO and the American Association for the Study of Liver Diseases. This is clearly a dangerous departure from SOC and an abuse of power. knows very well the guidelines, but he may like ?to save? his resources by not doing all the SOC EGDs that the cirrhotic Veterans need. Dr. - cannot establish a dangerous clinical care for Veterans, to obtain some personal benefits. Otherwise, if he has no ulterior motives, his behavior is erratic for recommending a dangerous departure from SOC. It is irrelevant whether Dr. - - had asked other members of the GI Section to restrict EGDs for Child- Pugh class A cirrhotic patients. The complaint was substantiated by own email of December 2015, to the GI NP, the Hepatitis RNs the Hepatitis NP, Hepatitis Physicians, and the Hepatitis Pharmacists . Sent: Tuesday, December 01, 2015 10:48 AM L- If a patient has CHILD A cirrhosis and and has been cured from Hep I do not recommend EV screening Dr. - - departure from SOC is a substantial danger to Veterans and public health at the VASDHS and an abuse of power. The leadership and the OMI have neither acknowledged nor reported these violations in medical practice. The Chief of Medicine, II. the Chief of Staff, - -, and the Director, - I - I. are responsible for these violations. c] Surveilance for Liver Tumors: On May 5, 2017, I informed the OMI via email that This week, the Chief, GI, ordered verbally the GI NP to stop the surveillance for HCC (hepatocellular carcinoma, a prevalent liver cancer) in Veterans with decompensated cirrhosis (Child class C). This was done in the presence of the Case Manager for GI procedures scheduling?. Both the GI NP and the Case Manager for GI procedures/scheduling are Veterans. Dr. - - has coercibly asked the former and current GI NP not to order liver Ultrasound (CT scan or MRI) in Child-Pugh Class (very ill) cirrhotic patients since as stated by Dr.- to the current GI NP and to the Case Manager for GI procedures the reason to stop was because these patients are going to die in a year anyway?. Dr. - - has also stated the same to me and the former GI NP on several occasions. Certainly, this is a significant departure from the VACO guidelines (see below). Dr. - - also requested to stop doing surveillance for cirrhotic Veterans cured of Hepatitis see email below) . This ?order? is also against the VACO guidelines and a dangerous departure from SOC. From: Sent: Monday, February 29, 2016 5:35 PM To: ; Subject: guidance for stopping surveillance in cured cirrhotics Here are some rule[s] for helping us stop doing surveillance on a cured cirrhotic – please incorporate this into our SOP for doing the recalls on patients for the ultrasounds, thanks ----------------------------------------------------------------------------------------------------------------------------------------------The former GI NP has also stated that Dr. has ‘ordered’ her to stop the SOC imaging for surveillance of liver tumors, resulting at least on one ocassion in the late diagnosis of a liver tumor in a Veteran. This Veteran required liver transplantation since the tumor was not amenable to other treatments at the time of diagnosis (performed by the former GI NP months later, against the ‘order’ of Dr. My Comments: The guidelines of the VACO (https://www.hepatitis.va.gov/provider/guidelines/2009cirrhosis.asp#S5X) and the American Association for the Study of Liver diseases indicate the need for cirrhotic patients to undergo liver Ultrasound every 6 months (“Surveillance for HCC is indicated for all patients with a diagnosis of cirrhosis, …”). A study in US Veterans showed that screened patients were 10 times more likely to have received potentially curative treatment, which in turn led to an improvement in survival. HCC surveillance is the SOC in the US and the VA System. This disregard for Veterans’ medical care is part of a pervasive pattern of unprofessional behavior displayed at the VASDHS for many years with the complicit ‘deliberate indifference’ of the Chief of Medicine (informed in June 2013, and in August, November and December 2016), the Chief of Staff (informed in August, November and December 2016), and the Director (informed in August, November and December 2016), VASDHS. These violations of SOC are a substantial danger to Veterans and public health at the VASDHS and an abuse of power. The VASDHS’ leadership and the OMI have neither acknowledged nor reported these violations in medical practice. The Chief of Medicine, ., the Chief of Staff, are responsible for these violations. , and the Director, d] Treatment of Liver Tumors: On April 4, 2017, I informed the OMI that there has been a “significant neglect of Veterans referred for liver cancer treatment not available at the VASDHS”. The OMI elected not to analyze this issue (apparently, the OMI believed that it was irrelevant). The Director, Liver Tumor Board (LTB), has stated that “…. I have made numerous referrals for Y-90 radioembolization [for the treatment of liver tumors] to UCSD and Palo Alto, and the appropriate medical information has never been sent for any of my patients except by me” ; “As a physician, it is extremely disturbing to hear that you do not process them [the consults] and instead discontinue them”; and “Their lack of response [from the Non- VA Care at the VASDHS] has resulted in several cases of marked delay of care”. The Director, LTB, has tried to bring Y-90 radioembolization for the treatment of liver tumors to the VASDHS and “…placed a comprehensive proposal 2 years ago, but it languished on the current Medical Director’s desk and was forgotten despite repeated follow-ups”. As stated by the Director, LTB, “It is truly a matter of life and death, a last hope for these Veterans [with liver cancer].” Substantiating, at least in part, the complaint about the irregular closing of consults at the VASDHS, the Director, LTB, stated that “sometimes the staff closes the consult and gets it WRONG (this has happened on numerous occasions - sending patients to radiation oncology when my consult clearly states interventional radiology).” The VASDHS’ violations of SOC and irregulaties in the closing of consults are a substantial danger to Veterans and public health at the VASDHS . The VASDHS’ leadership and the OMI have neither acknowledged nor reported these violations in medical practice. The Chief of Staff, these violations. • , and the Director, are responsible for Reprisals to Withleblowers at the VASDHS (Some Representative Examples). a] Selective Application and Enforcement of Government Ethics Laws & Rules for Whistleblowers. It is a remarkable coincidence that in 2014, after Dr. and I had reported, as Whistleblowers, the violations in Clinical Research and antagonized the VASDHS’ Research leadership on their complicit handling of violations of human rights , the Associate Chief of Staff, Research & Development, Ph.D., the Compliance Officer, , and the CEO , Veterans Medical Research Foundation, Ms. have selectively implemented the 18 U.S.C. § 208 (a) Rule against and myself for the first time at the VASDHS Research Service. “Federal Government employees are prohibited from participating personally and substantially as part of official duties in a particular matter that has a direct and predictable effect on their financial interests or the financial interest of their spouse, minor child, outside employer, or certain others.” (18 U.S.C. § 208 (a)). Dr. and I disputed both the applicability of the Rule and its rather highly discriminatory application. Indeed, on April 5th, 2018 in a Seminar presentation at the VASDHS, , Technology Transfer Specialist, Office of Research & Development, VA Central Office, agreed with Dr. that the rejection of her NIH grant Subcontracts, and the refusal to allow her to even apply for a waiver, was a violation of VHA Rules and Regulations. Dr. Dr. Ms. Dr. and I are aware of several VASDHS Investigators that have had highly significant ethical conflicts of interest (including four distinguished Investigators that are founders of Companies and perform research at the VASDHS that “has a direct and predictable effect on their financial interests”), but they have not been subjected to the 18 U.S.C. § 208 (a) Rule by Dr. Dr. and Ms. Dr. Dr. and Ms. have violated the Federal Whistleblower Protection Act and/or engaged in another type of discrimination against the VHA Rules and Regulations, and the Veterans Medical Research Foundation’s Rules and Regulations, as described at the time in its website. The VMRF website description, allowing for this type of grant application (NIH R-41, Phase1 STTR grants), was ‘conveniently’ disappeared later by Ms. Dr. and I believe that our Research colleagues should not be subjected to 18 U.S.C. § 208 (a) Rule, but that the selective, targeted, and incorrect application of the 18 U.S.C. § 208 (a) Rule against us was a retaliatory and illegal action. The targeted, discriminatory action of Dr. Dr. and Ms. resulted in considerable damages to Dr. and my academic carriers since we had to transfer two contractually approved NIH grants to UCSD with a marked delay in completing the research goals of the grants and in obtaining renewal grants. b] Termination of Wisthleblower Dr. Position at the VASDHS. Remakably, a sabotage occurred in Drs. and laboratory space on the evening of April 5, 2018 (after Dr. agreed with Dr. , in the presence of the Associate Chief of Staff for Research , Dr. that the rejection of her NIH grant Subcontracts, and the refusal to allow her to even apply for a waiver, was a violation of VHA Rules and Regulations). Someone with access to the master key came, and turned off one of the -70 0 C freezers. However, investigation of fingerprints, or who had the master key was not pursued since “…Chief [of Police] conducted follow-up character reference interviews, and found a long history of false claims made against Dr. by Dr. and [Dr.] This is another evidence of character assassination against the Whistleblowers by Dr. and/or Dr. Immediately after the sabotage, Dr. sent an email to the Associate Chief of Staff for Research, Dr. and Cc to VASDHS/VMRF/UCSC leadership, who were already informed of the previous Whistleblowers’ allegations (Dr. VASDHS Director; Ms. CEO, Veterans Research Foundation; and Dr. , UCSD Vice Chancellor and Dean, School of Medicine), to include this most recent retaliation. The Whistleblowers would like to remind the readers that these retaliations have been occurring since 2013. ----------------------------------------------------------------------------------------------------------------------------------------------Fri 4/6/2018 9:25 AM [EXTERNAL] -70 freezer sabotage Gery, Someone came into Dr. lab space [ that I now share as I have none of my own here at the VA anymore], and turned off one of the -70s. The power button had to be turned off by a person possibly as long as several hours ago, for me to find it like this at 8AM this morning. The freezer had warmed up to-36 C. I will go into the engineering protocols and calculate the range of time involved and get back to you with a solid estimate of time when this probably happened. It is interesting to note that this occurred just a few minutes to hours after I went to the presentation by Dr. [yesterday afternoon] where it was confirmed as "wrong", that my NIH grant was expelled from the VMRF in 2014. This expulsion led to all my myriad professional and financial problems here and at UCSD. When I presented the scenario to Dr. as I had presented it to you, and Ms with Dr. as a witness and only unbiased account, at the time, Dr. without any prompting from me asked if that action was supported by Ms. When I affirmed it had been, he stated that he had a history of these kinds of problems with her. However, my expulsion was not initiated by Ms. It was initiated here locally and was strenuously spearheaded at the time by you, Ms. and Dr. Obviously, that may not be the order of the hierarchy. Indeed, using Dr. these actions were carried over to UCSD and caused delays of at least three grant cycles in which time, as I mentioned yesterday a VA co-owned patent rights were dropped and went public. My other damages are too numerous to describe here now. That VMRF expulsion occurred after Dr. and I brought our whistle-blower complaints to all of you. The expulsion was cited as 208 mandated. Ms. suggested in an email that was sent to me by mistake at the time of the expulsion, that the 208 might be a way to get me out. I strenuously argued all the points that I gave to Dr. at that time to all of you to no avail. Indeed, that same week, you told Dr. and I that you were unfamiliar and were just learning the 208 yourself! But apparently you still felt confident to apply it to us. Had or has it ever been applied to anyone else? While we were not eligible for a waiver, contrary to Dr. opinions yesterday, apparently Dr. is by these same standards? Or as I have been arguing for years now are different standards being applied to me? Would this be because I'm a whistleblower? ? Because I am female or because I am Native American? Whatever, the reason it cannot be a good one. This sabotage goes well beyond whistle blower retaliation which we have been subjected to for all this time. Since these labs are in a secure space, and the claim is that they are controlled at all times, that argues that it can be established beyond any doubt who did this. I want to know. It is a felony. These are federally protected reagents, and patient samples. Unlike in the past where 'special' people have been allowed to intentionally promote the exposure of pregnant women to X-rays for research purposes without any repercussions because as Dr. stated, "I believe he has learned his lesson", I'm not going to let this one go unpunished. There is documentation of this research protocol and intentional violation of the policies of human research practices and principles by the OHRP, in the SRS Minutes and Dr. interview notes with me at that time. There is no doubt that this occurred and there has never been any local investigation or comment on it. Allowing this protocol to continue without repercussions to the PI has been what has generated the present violations. These present violations [still under OSC investigation] will now involve the research samples, publications, and practices of multiple UCSD faculty that were not initially impacted or even involved and would not have been if the investigation had been properly conducted here at the VA and the IRB protocol properly punitively managed and monitored. But as usual instead of facing the problem and cleaning it up, the VA leadership went after the whistleblowers. We are becoming lawless in the VAs across the whole Nation, and this one is no exception. Whistleblowers are being attacked, and I for one am going to start fighting back now with every resource at my disposal. This has now gone too far. What is going to happen next? I have already been harassed by Dr. after hours on my personal cell phone. I had my VA and UCSD space taken away, with my UCSD space moved to Hillcrest as an additional hardship. I have been repeatedly told by you that I cannot get paid any longer on my collaborator's grants . But when I am the PI on any applications, he can and should get paid as a collaborator on mine. Regardless that I was paid on his grants well before . Indeed, the reviewers at NIH requested my paid effort be added to his grant application. I have been told by the UCSD Office of Discrimination and Harassment [or whatever they are called now], that this isn't a protected status [regarding Dr. activities against me and Dr. He had a 'secret' investigation going against Dr. that only Mr. and he were to be privy to. This is against UCSD faculty rights and policies, and occurred while Dr. refused to answer dozens of professional administrative emails.] only straightforward harassment so not under their purview. I have taken it to the HR for the Medical School and they told me that yes it was harassment, but this is the Medical School, and these are important people, what can we do? Apparently, nothing. I'm pretty sure that it is a State mandate that all state institutions including the UCSD School of Medicine have functional HR Departments. I want an immediate VA and VMRF investigation into the sabotage of this freezer. I want to know who the guilty party is and I want to know what the punishment will be. This lab was locked at the time and there are a limited number of people who have access. Everyone that came down the West wing hallway during those hours can be known as it should all be recorded the computer system. If the computer system has been altered there are a very limited number of people that can do that too. I understand that exits [due to the use of the emergency button or certain stairwells] cannot always be documented but entries can be. I am aware that leadership blames all these problems on us, the whistleblowers. But we did not do any of these things. Indeed, leadership at the VA and at UCSD has been looking everywhere that they can to try and find any way possible to damage us. They have damaged us tremendously. So, if that is the intention, they should be proud. But they have also protected an individual who wanted to expose pregnant women to X-ray for research purposes calling it standard of care. This alone makes it a toxic work environment to me and it should have that impact any every living decent human being. This protection has generated human research that is in violation of OHRP policies and laws. These violations have spread to UCSD and will impact negatively several faculty there. Of course, leadership can argue that these violations should never come to light. That they should not be reported. I am unable to stand by and let these atrocities happen. These are not a simple 'sloppy record keeping' issues. Where data that is questioned as having been performed or not, is lost, has no documentation so cannot be clearly adjudicated. These are violations against human beings. They are human rights violations. Many of you are clinicians. Where is your basic human dignity? Is this the way that you want your family, friends, and loved ones treated? I understand that the person in question is in leadership, so he is one of your own. But there is a bigger picture here. Before you were in leadership, you are human. You were a fetus once too. Should it just be left to one person to stand up and say that we, as a society don't condone the exposure of fetuses to X-rays for any reason other to save the mother or baby's life? We do not do this for research! If it is left to one person to do that, should her professional and personal life be threatened by the leadership of both institutions, for several years? Is this really what all of you want to stand for? ------------------------------------------------------------------------------------------------------------------------------------------------The VASDHS’ leadership terminated the position of Whistleblower Dr. on , 2018 with only 30-minute warning, and because Dr. was apparently ‘creating a hostile work environment for the ACOS of Research, Dr. with her Whistleblower allegations (see email above). Thus, according to the VASDHS’ leadership, Whistleblowers are not tolerated at the VASDHS since denouncing violations of human rights and sabotage creates a hostile work environment. Of note, all the violations in clinical research (Allegation # 1); the poor clinical practices (Allegation # 2); and the closing of Consults by non-clinical personnel with violations of HIPAA, IT, patient care, and probable fraud (Allegation # 3) were considered trivial by the VASDHS’ Director, Dr. on February 14, 2017 (“…were unable to substantiate any behavior that was sufficiently severe and pervasive to create a hostile work environment. As such, this matter is considered administratively closed.”) (see above). Dr. has had an impeccable and outstanding record of service at the VASDHS for > 25 years. Once she become a Whistleblower she also become the target of reprisals from Dr. Dr. Ms. and others at the VASDHS’ leadership. These retaliatory actions against Whistleblower Dr. are illegal, and need to be investigated by an independent group. The VASDHS and Veterans Medical Research Foundation individuals responsible for these actions should be punished accordingly, and Dr. reinstated at the VASDHS. The Members of the VASDHS’ Executive Committee (the Director, .; the Associate Director, Ms. the Chief of Staff, MD, MPH; the Associate Director, Ms. ; and the Assistant Director, Ms. ) who made the decision to terminate the VASDHS’ appointment of Dr. are responsible for this retaliatory, illegal action. In addition, Dr. is also responsible for this retaliatory, illegal action against Dr. since he initiated investigations against Dr. claiming that Dr. had created a hostile work environment for him. However, nobody has challenged the veracity of the Whistleblowers’ allegations. Further, on June 15, 2018, Dr. ordered the VASDHS’ Police ‘to remove Dr. from the Research Service’ two days after her termination, while Dr. was attempting to access her former laboratory to remove personal items (after registering appropriately with the VASDHS’ Police). In addition, Dr. has ordered the VASDHS’ Police to escort Dr. through the VASDHS’ Hospital up to the Research Service every time that Dr. needs to complete an inventory of her research work product. The ACOS for Research, Dr. repressive behavior displayed against Dr. should not be tolerated in a federal institution, and it is intended to denigrate and humiliate her in front of her VASDHS and UCSD colleagues. Indeed, it could be convincingly argued that this vengeful and oppressive behavior by Dr. using the VASDHS Police to repress, silence and abuse a Whistleblower (who has already been terminated), truly demonstrates who has been the aggressor and creator of a hostile work environment all along, as Dr. and I originally claimed. This behavior is not any type of allegation or protected practice, nor is it customary for Research Service visitors. It is designed to keep Dr. from talking to colleagues, and to make her look like a ‘trespasser’ on the Research Service. The objective and the achievement is to isolate Dr. personally and professionally and irreparably damage her scientific collaborations at the VASDHS/UCSD. As it is common in all repressive situations, this ‘teaches’ the population involved that the Whistleblower is the guilty party, and that there will be consequences for any association with Whistleblowers or any actions of whistleblowing. These violent reprisals against an outstanding ‘citizen’, Whistleblower, and VASDHS’ Investigator has caused Dr. dramatic professional and emotional damages, reflecting the hatred of the VASDHS’ leadership against Whistleblowers. Without an appropriate and rapid intervention by the OSC or Congress, Whistleblowers have no protection here at the VASDHS and UCSD against these abuses of power. In addition, on August 2nd, 2018, Dr. received a Notice of Intent of Non-Reappointment from Dr. , UCSD’s Assistant Vice Chancellor, and from Dr. Chairman, UCSD Department of Medicine, indicating “… your appointment will now end on October 2, 2018… The reason for this action is a lack of funding for you to continue in your current role …” This shows a remarkable coordination between the VASDHS’ leadership and the affiliate UCSD’ leadership in retaliating against Whistleblower Dr. These individuals may have some labor laws on their side but it appears to many unbiased observers that they have committed a crime by violating the Federal Whistleblower Protection Act. Dr. was informed on 6/7/2013 (see above) but against UCSD/VASDHS policy, he did not investigate alleged criminal violations in Clinical Research by a UCSD/VASDHS Professor in his Department. In 2015, Dr. passive-aggressively postponed by > 6 months a routine transfer to UCSD of the NIH grants expelled maliciously from VASDHS/VMRF (delaying significantly the completion of those NIH grants, and consequently, in obtaining new NIH grants). On 3/26/2015, in violation of UCSD/VASDHS policy and the Federal Whistleblower Protection Act, Dr. called Dr. after hours and to her cell phone to harass her about baseless conjectures on his part (see above). In addition, the lack of a 2017 Government Budget until 5/5/2017 prevented Dr. to obtain NIH funding despite of an outstanding review and score of one of her grants. In November 2017, Dr. received a perfect score of 10 from the NIH on one of her grants but a technical issue (budget exceeding the limit in one category) postponed funding until resubmission on September 5, 2018. This involuntary technical error by the Whistleblowers (our first ever) was the result of the cumulative harassment that we have been subjected by the VASDHS and UCSD leadership since our Whistleblower disclosure in 2013. Why the coordinated retaliatory actions against Dr. by the VASDHS’ leadership and the UCSD School of Medicine’ leadership? It reflects the severe Conflict of Interest of many of these individuals, and hence the progressive escalation of the cover-up and the retaliation against the Whistleblowers. Representative examples of the overlapping roles of these individuals at the VASDHS and UCSD are shown below. Therefore, the coordinated inactions (to dismiss Whistleblowers’ allegations without investigation or with ‘minimalist’ investigations), as well as the coordinated retaliations can be readily understood. Dr. Chief of Medicine VASDHS, is the Medicine Supervisor at the VASDHS for the VASDHS Chief, GI, Dr. Dr. Staff Endocrinologist, VASDHS, and Chairman, UCSD Department of Medicine; Dr. , UCSD’s Assistant Vice Chancellor and Staff Cardiologist, VASDHS; and me (VASDHS Staff Gastroenterologist, and a UCSD Professor of Medicine). Dr. Associate Chief of Staff for Research, is the Research Supervisor at the VASDHS for the VASDHS Chief of GI, and VASDHS Investigator, Dr. Dr. Ross, UCSD’s Assistant Vice Chancellor, and VASDHS Investigator; Dr. VASDHS Investigator; and me (VASDHS Investigator). Dr. Director VASDHS, is the Supervisor at the VASDHS for Dr. VASDHS Chief of Medicine and UCSD Professor of Medicine; Dr. VASDHS ACOS for Research and UCSD Professor Emeritus of Anesthesiology; and Dr. VASDHS CO. Dr. Chairman, UCSD Department of Medicine, is the UCSD Department of Medicine Supervisor for the former Chief, GI and UCSD Professor of Medicine, Dr. Dr. Vice Chairman and Professor, UCSD Department of Medicine; Dr. Director VASDHS and UCSD Professor of Medicine; Dr. Ross, UCSD’s Assistant Vice Chancellor and UCSD Professor of Medicine; Dr. UCSD Associate Professor of Medicine and me ( UCSD Professor of Medicine). Dr. , UCSD Vice Chancellor, is the Supervisor at UCSD for Dr. Vice Chairman, UCSD Department of Medicine; Dr. Chairman, UCSD Department of Medicine; Dr. UCSD’s Assistant Vice Chancellor; and Dr. UCSD Professor Emeritus, Anesthesiology. All these hierarchical professional positions create a quagmire of conflict of interest and lead to obvious retaliation of Whistleblowers at the companion institution. Indeed, the violations themselves, having occurred at the VASDHS have already spread to UCSD by disputed human materials being used in publications, and potentially on grant applications. c] Selective Application of CPRS Auditing and Retaliation I received a Memorandum from Dr. dated July 20, 2016 regarding Performance Counseling-Chart audits for re-credentialing. Dr. stated that “…. based on mandatory chart audits for the privileging process some deficiencies were noted in clinical note[s]”. Dr. audit was subjective, biased, and/or inaccurate. His audit had many conceptual medical and factual errors. The timing of this audit and Dr. finding of my apparent ‘deficiencies’ are remarkable since they occurred after I had reported Dr. violations in SOC and in Clinical Research, and for the first time in my career at the VASDHS and UCSD, the NIH, the West Haven VA and Yale University. The October 15, 2012 VHA Handbook 1100.19 under j. Reappraisal and Re-privileging does not make any reference to mandatory audits. In addition, under h. Triggered Reviews, it is specified that (2) The criteria that would trigger a more in-depth review must be defined in advance, and be objective, measurable, and uniformly applied to all practitioners with similar privileges. Dr. ‘agreed’ with my position on August 3, 2016 (see email below) but he never investigated the Whistleblower retaliation against me. ----------------------------------------------------------------------------------------------------------------------------------------Dr. Thank you for bringing your concerns to my attention. Retaliation against whistleblowers is unacceptable as is creation of a hostile work environment. Additionally, you may not be held to a different standard than any other GI physician...... I will assure that your allegations are investigated. Director VA San Diego Health Care System ------------------------------------------------------------------------------------------------------------------------------------------------------ However, after many unssuccesful attempts in obtaining the required information , I wrote the following email to Drs. and on 12/23/2016. ------------------------------------------------------------------------------------------------------------------------------------------Dear Drs and I agree that the CPRS audits are valuable and necessary. However, to be successful, the audits need to accurate and fair. I believe Dr. audit of my CPRS Notes was neither accurate nor fair…. I have requested from Dr. [ several times in writing on August 5, 2016 and in person during July and August 2016] and from Dr. on August 2, 2016 and November 21, 2016 the following: 1] The Recredentialing Committee’s membership and some way to respond to the audit of my CRPRS notes; 2] the guidelines and detailed criteria upon which we are all being reviewed in the GI Section; 3] all my previous reviews. Dr has already told me that he does not have any of my previous reviews nor any guidelines of the standards of the review process. As a clinician and scientist, I believe that it is impossible to perform any audits or evaluations in an unbiased and standardized/equal fashion in the absence of any guidelines. The VA always has criteria that is well established, even if locally, prior to any evaluation procedures. In addition, the VACO is concerned about any potential appearance of COI in the evaluation process. 4] I would like to be made aware of if and how my claims that the majority if not all of Dr. audit was in error. Not that he was in error to audit my charts, but rather the content of his audit was in error. 5] the process of the audit was also irregular. I was never trained in the standards by which I would be reviewed nor was I ever given any previous reviews. How could this be a learning/improvement process without those elements? If it is not to be a learning/improvement process, then can the goals of the process also be clarified for me? I will also need you to corroborate that similar audits of other GI section physicians requesting also recredentialing (before July 2016 and ACCURATELY dated as such) were performed by Dr. ----------------------------------------------------------------------------------------------------------------------------- ------------------------------- As of today , I have not received any of the requested information, strongly suggesting a violation of the Federal Whistleblower Protection Act and/or another type of discrimination, as well as a cover-up by the VASDHS’ leadership. The Chief of Medicine, • ., the Chief of Staff, are responsible for these violations. , and the Director, Summary of my Comments for Allegations # 2 & # 3: I have suffered repression by a brutal, and unjust military government in Argentina, but I was fortunate to escape and be welcomed to my new country, the USA. Unfortunately, the ‘leadership’ at the VASDHS reminds me of the ‘leadership’ practiced by the military regimen in Buenos Aires University Medical School. They had only one objective: the progress of their personal agenda in detriment of the students, staff, faculty, and patients. The VASDHS’ ‘leadership’ is only interested that the numbers look good in detriment of the personnel and Veterans. They have used unjust retaliation as much and as often as needed to achieve their personal agenda. They have directly perpetrated violations of VHA Rules & Regulations, and/ or Federal Acts, as well as indirectly to coverup despicable violations of VHA Rules & Regulations, and/ or Federal Acts by ‘friends of the leadership’. I found it remarkable that the VASDHS’ ‘leadership’ has used brutal, and unjust retaliation against two women Whistleblowers with outstanding records of performance. A new type of Un-Equal Employment Opportunity against Whistleblowers developed by the VASDHS’ ‘leadership’? The VASDHS, UCSD, OMI, and Veterans Medical Research Foundation leadership (Drs. Ms. and Ms. VHA Rules & Regulations, and/ or Federal Acts. and have performed activities that have violated many If the Congress does not intervene rapidly to block the VASDHS’ leadership, and to protect the Whistleblowers, it will allow the persistence of gross injustices against personnel and thousands of Veterans. The VASDHS’ leadership, the OMI, and the Department of Veterans Affairs, former Chief of Staff and Executive in Charge are clearly adopting a ‘deliberate indifference’ approach by using tangential issues, while trying not to substantiate the Whistleblowers’ complaints. I believe that the conduct of the OMI needs to be analyzed since according to the OSC, most of the OMI’s Reports are inadequate (OSC’s website). Clearly, the OMI is inept and/or corrupt. I ask the appropriate Investigational groups to analyze the conduct of the individuals involved in the (or lack thereof) investigations. It is remarkable that the VASDHS’ leadership, the OMI’s investigators, the former Chief of Staff and the Executive in Charge, Department of Veterans Affairs, found that thousands of HIPAA violations (a Federal Act); thousands of medical Consults closed without an appropriate clinical review; violations of human rights in Clinical Research; and dangerous departures of medical practice are not serious enough to substantiate these complaints. I ask the Congress (1) to assess the degree of professional misconduct at the VASDHS by the former Chief of GI, the Chief of Medicine, the Chief of Staff, the Director, the CO, the ACOSR, and the Chairman of Medicine, UCSD and a VASDHS Staff Physician, and the CEO, Veterans Medical Research Foundation ; (2) to adopt measures to protect the Veterans from the danger to public health at the VASDHS, as well as the personnel from abuse of power (including total disregard to Whistleblowers’ allegations of potential civil and criminal violations, and the retaliatory actions against the Whistleblowers ) ; and (3) to reinstate as soon as possible the Wistleblowers Ms. and Dr. at the VASDHS/UCSD. The perpetrators of the despicable violations of VHA Rules & Regulations, and/ or Federal Acts, should be investigated according to the protection provided by the US Justice System. Our nation cannot tolerate a system of impunity for the ‘leadership’ and ‘friends of leadership’ at the VASDHS and at UCSD. Our country cannot tolerate gross abuses against federal employees and Veterans at the VASDHS or anywhere else. James Madison stated “… an officer … may be guilty of actions that ought to forfeit his place; the power of this house may reach him …, and he may be removed even against the will of the president…” (Madison Papers, 19 May 1789). Thus, if a government officer can be removed by the Congress, why cannot Congress request the removal of a Director and the rest of the leadership if responsible for despicable actions at a VA Hospital, and set a precedent? “Democratic societies founded on the rule of law and strong, accountable institutions, as well as transparent and inclusive decision-making processes, are more likely to provide effective protection of human rights. Impunity allows gross human rights violations to thrive” (Rule of Law at the National and International Levels, 24 September 2012; UN). There is no democracy without freedom, there is no freedom without justice, and there is no justice with impunity. Thus, impunity of a group of individuals associated to perform and /or coverup violations of VHA Rules and Regulations is incompatible with the justice, freedom, and democracy that our Founding Fathers envisioned, and that these Veterans have risked their life to defend. Respectfully Submitted, U.S. OFFICE OF SPECIAL COUNSEL , l730M Street, N.W.• Suite 300 Washington, D.C. 20036-4505 The Special counsel November 2, 2018 The President The White House Washington, D.C. 20500 Re: OSC File Nos. D1-16-1945 and D1-17-1294 Dear Mr. President: Pursuant to 5 U.S.C. § 1213(e)(3), I am forwarding to you reports from the Department of Veterans Affairs (VA) based on disclosures of wrongdoing within the VA San Diego Healthcare System (VASDHS), San Diego, California. Dr. and Dr. who consented to the release of their names, di~ ch1ef of the Gastroenterology Section at V ASDH~ ed patients at risk by ~ unapproved human research. Dr. -and Dr.submitted c9mments on the VA's report on February 25 and Febru~ Ol8. I have reviewed the agency reports and whistleblowers' comments and, in accordance with 5 U.S.C. § 1213(e), provide the following summary of the reports and my findings. 1 I. Executive Summary The whistleblowers disclosed that Dris performing transjugular biopsies on seriously ill patients as part of a research pro= , placing patients at serious risk. The whistleblowers asserted that transjugular biopsies do not represent the standard of care for the relevant patient population and.that the biopsy samples obtained were not considered "archival" for the purposes of the approved research protocol. 2 The VA did not substantiate the whistleblowers' allegations but provided inconsistent explanations for its findings. For example, the VA asserted that transjugular biopsies are the standard of care for these patients but failed to adequately reconcile this finding with the fact that, prior to the research protocol, no transjugular biopsies were performed at VASDHS. In light of the serious nature of the whistleblowers' allegations and the VA's unsatisfactory support for its investigative findings, I have determined that the VA's report appears unreasonable. 1The whistleblower's allegations were referred to former VA Secretary Robert J. Shulkin for investigation pursuant to 5 U.S.C. § 1213(c) and (d). Fonner Secretary Shulkin delegated the responsibility to review and sign the reports to fonner Chief of StaffVivieca WrighJ Simpson. . 2 The whistleblowers noted that the legal definitio·n of standard of care is the level at which the average, prudent provider in a given community would practice. The Special Counsel The President November 2, 2018 Page2 of6 II. Allegations of Unapproved Human Research a. The Allegations Dr.the disclosed that the VASDHS lnstitutio ev1ew oar approve r. proposal to perform transjugular biopsies on patients diagnosed with alcoholic hepatitis for a research study involving alcohol-related liver injuries and the presence ofbiomarkers. Dr.objected because it was his belief, and the belief of other experts, that transjugular biopsies are not the standard of care for patients suffering from alcoholic hepatitis, nor are they necessary for diagnosis. The procedure also creates a serious risk of excessive bleeding and possible death. 3 Dr.• disclosed that the IRB's approval was limited to the use of archival biopsies-biopsies already in existence-but, because biopsies are not the standard of care for this population, none were available. Drfurther disclosed that Dr.• is not informing patients of the serious risks associated with the biopsies as required by most human research protocols and is not informing patients that their biopsy will be included in a research project. Patients are instead led to believe that biopsies are taken for diagnostic purposes only and are a necessary part of their care plans. b. The VA 's Findings The VA did not substantiate that Dr.• is performing unapproved human research without informed consent. The agency not:cr,\owever, that the members of the IRB who approved Dr. 11111 research were not qualified to determine whether transjugular biopsies were the 'appropriate standard of care for the relevant patient group. Further, the IRB did not consult independent clinical providers with experience treating patients with alcoholic hepatitis until April 2014, a full year after the research was approved. While the approved research protocol was limited to archival biopsies, the VA argued those biopsies could be obtained prospectively for clinical purposes. At the time of the agency's report, nine patients (of a total of thirty-eight, including those in the control group) had undergone transjugular biopsies, which were shared with the research study. The VA determined that all nine patients received appropriate care given their clinical conditions. The VA also acknowledged that VASDHS management failed to appropriately follow up on D~ ethical concerns about the research study. The investigation found that Dr. ~ rnent of the research team was lacking. For example, Dr. delegated many of his research oversight responsibilities to his study coordinators, who • 3 Dr. noted that the American Association for the Study of Liver Diseases does not recommend biopsies due to the risks associated with the procedure. The Special Counsel The President November 2, 2018 Page 3 of 6 lacked appropriate training and, in one case, obtained informed consent from a patient before the IRB approved the coordinator to participate in the study. In addition, Dr.. . research records were incomplete and communication between Dr. and the study coordinators was poor. • • Additionally, the underlying master protocol for Dr.. . research did not include a control group of patients without liver disease. In April 2014, Dr. submitted an amendment to the IRB to add a control group to his study. The requested amendment did not detail the goal of adding the control group, nor did it describe how the data from the control group would be analyzed. Nevertheless, the IRB approved the requested amendment. The VA found that while patients with alcoholic hepatitis did receive consent statements that appropriately explained the parameters of the study, patients in the control group did not. Control group patients were not informed that their samples would be sent to a co-investigator's laboratory. Samples from control group patients included personally identifiable information restricted by the Health Insurance Portability and Accountability Act of 1996 (HIP AA) and included a dietary questionnaire that was not fully described in the !RB-approved protocol. Despite these shortcomings, the VA determined that the research protocol's provisions for ensuring that patients were capable of providing informed consent were appropriate. OSC requested a supplemental report clarifying the VA's findings. OSC specifically asked the VA to support its contention that transjugular biopsies were the standard ·o f care for the relevant patient cohort, given that (1) VASDHS had performed no transjugular biopsies until after the approval of the research protocol and (2) experts in the facility, including Dr. asserted at the time that transjugular biopsies were not the standard of care. The VA explained that the introduction of the research study opened the facility up to a clinical option-transjugular biopsy-it had not previously explored and that this was why they only began performing the biopsies after IRB approval. The VA also stated that in April 2014, after the IRB approved the research, it consulted the acting Chief of Liver Transplants at the University of California, San Diego (UCSD), who asserted that transjugular biopsies were the standard of care for the research patient cohort. OSC also requested further explanation of the VA's determination that archival biopsies included biopsies obtained prospectively for clinical purposes. The VA explained that, while the whistleblowers had reviewed an initial version of the protocol that referenced archival biopsies, "IRB minutes and correspondence between the IRB and the investigator reflect IRB approval of a revised version of the protocol in which surplus tissue obtained prospectively for clinical purposes may be used for the research." The special Counsel The President November 2, 2018 Page 4 of6 c. The Whistleblowers' Comments Dr. 11111 emphasized her concerns with the VA's standard of care determination. She noted that neither VASDHS nor UCSD, both part of the San Diego community, performed transjugular biopsies on patients with alcoholic hepatitis until-after the initiation of the research study. The lack of transjugular biopsies prior to the study is a strong indication that transjugular biopsies are not, in fact, the standard of care for these patients. In addition, she noted that scientific literature does not support the VA's standard of care finding and that the biopsied samples do not contain sufficient histological markers to make a firm diagnosis. Dr. 11111 also stated that the VA's Human Research Training explicitly defines archival samples as "samples already obtained ("on the shelf') prior to the approval and initiation of any research." Thus, the prospective acquisition of samples, as described in the agency's report, would not meet the VA's definition of archival in its initial report. Dr. 11111 also highlighted the shortcomings with consent and the management of the research project, expressing skepticism that consent statements could be valid when collected by an unapproved study coordinator or when in violation of HIP AA privacy rules. Further, although the VA found that the research protocol included sufficient provisions to assess patients' decisional capacity, Dr. 111111 asserted that Dr. found no cognitive evaluations in any of the relevant patients' charts. Dr. llllllnote---o~eaee -ea.:.information (PHI) will be disclosed to the academic affi ,ate. :he ,:IB rr....is- acc --e-s..i::: 2..- .1 instances of PHI and personally identifiable information ° '1 being disetoseo :o r.- a academic affiliate without subjects' consent or HIPAA authorization. Resolution: On October 26, 2017, the IRB reviewed this matter and found that both the ICD and HIPAA informed subjects that samples and data were being collected for 2 future use by participating lnTeam institutions/investigators, including the academic affiliate. The IRB confirmed that the academic affiliate is a participating In Team site. The IRS approved updated ICD and HIPAA forms that clarify the affiliate is a participating lnTeam site. Action Completed: October 26, 2017 Recommendation 6: When there is a difference of opinion in clinical management of this patient population , the Medical Center should use the Peer Review program to ensure that each patient's treatment plan meets the standard of care. Resolution: On August 30, 201'7, the Medical Center widely distribt.rted information to providers stating that if they experience a concern or a difference of opinion related to clinical practice, they should use the venues available to them , such as the ~ecrromc Patient Event Report, or report to their supervisor or the Patient Safety Manager; if warranted, each can lead to a peer review. On September 13, 201 7, at a meeting of aU section chiefs, the Chief, Medicine Service emphasized that providers may refer to the Peer Review process when there is a difference of opinion about standards of clinical care. Action Completed: September 13, 2017 Recommendation 7: Establish internal practice guidelines for practitioners on acceptable standards of care , specifically in the management of patients diagnosed with hepatitis and the frequency of surveillance endoscopies. Reso lution: On August 17, 2017, the GI Section Chief distributed suggested practice £-:C&-..,es . a email in advance of an a ll-staff meeting on August 29. At the meeting, - ::; s~ - : sc_ssed and agreed to the practice guidelines. Providers can find the most __ ::-- :c::±E ~Jidelines on the GI Section SharePoint site and in a shared folder ;::D::::55.-: ~~a.. providers during clinic hours. ~cmpfotad- August 29, 2017 ·=- - - _ ---=ir.:l-:::-·on 8: :>ro -~e ,...,'llediate training to all ciinrc staF regardiJ'lQ the 5<=--=-~~ss ;:-= -:=-: ~-~.Z:e-'"SSS ::~ s~~~~~ . ;.. s:aff rre,....,ners nass-,mrcs :o ~2-" ::'.'--.ass ::: • A c::m:-:Dl.,e- systems. The VATable of Penalties lists punishments rangrng 70-rn admonishment to removal, depending on the stated offense. Resolution: The Medical Center reported that all clinic staff are required to complete annual training on Privacy and Information Security and Rules of Behavior (P&IS) and comply with the content therein . The Medical Center reviewed P&IS training compliance for all medical service staff and sent training compliance delinquency reports to all section chiefs on September 1, 2017, for action. The Medical Center will continue this practice each month and expects section chiefs to take appropriate disciplinary actions with employees who do not comply with P&IS policies. Action Ongoing, with an expected completion date of March 1, 2018 . 3 Recommendation 9: Ensure all Medical Center staff members complete the required training regarding the use of, and access to, VA computer systems. Resolution: The Medical Center reviewed em ployee mandatory training compliance reports for P&IS. All reports of noncompliance are sent to the facility Privacy Officer (PO) and Information Security Officer ( ISO) for action. The ISO revokes computer access for anyone noncompliant with their annual training requ irements. Action Ongoing, with an expected completion date of March 1, 2018. Recommendation 10: Take appropriate administrative action in response to the Chief, Gl's, persistent violation of VHA Privacy and HIPAA and Rules of Behavior Policies by allowing staff to use his password to gain access to VA computer systems. Resolution: These actions were investigated by the Medical Ce nter and they concluded that the Chief, GI, violated P&I S, albeit not for nefarious reasons. Rather, he designed a solution to circumvent poorly designed technology, a solution that was not in oorno,·ance -1:m VHA policy On Seotember 1 2017. Medical Center leadersh ip met .•. · - e PO to ciscl.ss a so uUO"" ~r ~..,e tecru10K>gy prob em and provide optimaJ access ~ :;·•e e ir.zg-e ca":J:-"_-re so-':',..."a.re "p eacr oroced;J'"e roor1. while stir complying with :::i&_ S --£_ --s-s.-:s ~-s :>Q a'"'c 31C'.'ec·ca =ng reer re,,ewed each procedure room ~--: '""E::c--~--;=. --z: :..-e cc-::,~e- .· : :,-c .a~or so"7.:a"e use a ge neric log-on - --- - ::- 2. -:: ea:~ :::~ . .:er:: acecss ~- e =>"'O ._ a..:or. so~•.are -.vith his/her own .:.--::.:.-s--·c..s - -£ s:.::. - ·.:: -.. n- -- e c- e/ go.a access -.ac a ng!'k .:o use the network =-:.;. G·= ~=sc =, •-c :,-s~c- ·- e-c:...~ss sc ,..,o ?AA violation occurred. =-= = =- Recorr: en::ia ·o =--s....-e s-c---ec_ -.-;; a-c co,st..'t rra,nlng is being provided, at sa- £ "- .Jc J =ca a~=ec '/eel.ca Cerrer s-.aff members according to appropriate ., .-;.. :lo c,; a".c :r~ves e.g.. ~ : rrecti\,es -'230, Outpatient Scheduling Processes and ?rocedures (July 2016), VHA Directiv-e 1232, Consult Processes and Procedures (August 2016), and Medical Center memoranda. Resolution: In fisca l year 2017, VHA rolled out an updated face-to-face scheduler tra ining curriculum. AIJ staff who schedule appointments (indJia,n::s. ,-.e ce~err"·-,ec • at .. e c._.,...er: resea"Cr' COO"C '"lator on staff had limited ex~e--.ce ~ s .'."ciS -o~ ~'"'e same resear& coorc '1a~o,. cescribed in the preceding xc;a;:>s;., . ·e :....e~co'c -~...cec ·,.., :.-:..e ..e;:x::~ corcerriS -eo..,arding apparent w eakness ..., :.--e .......a.-2;e..... e.: c: :.~e --:-ea.T s~-'Ci as o.:>Sc•va..ors. :::,-'Scse aso s.r:: a - tre ,c. c •.: o: ::.- s co----ss--..s o::;:.s_·.-.ec ~r,-, control arm participants ce -.:a ........~... "e£a~·..,g ::-e -Se or :::, a--c t.""e =ntended use of -":: -a~'" o:::a..,....ec: ~..,.... c. c e:a...; c _esrror ...a -a...:...s ~ aoove, if the IRB acts as :.- ~ ia~ -e;::_ "'"e-o::-~e-~ee :c ~cc~. -.-e --~ ........ec CJ'1se--: coa....-ar:~ ......o.·, does such modification a:J:> _. ~ CO"'lse-1s a cao, :)Dc..... ec? ~ s OSCs u'1Cersrano;ng from the whistleblowers mat~ hoc approva ·s nm perrnruec for sruo1es ma. have already been conducted and involve identifiable data that can be connected to a living individual. If that is, in fact, the case, then it would appear to substantiate the allegation that proper informed consent was not obtained in this case. VA Response The whistleblowers alleged that active liver disease and alcoholic hepatitis patients w ere compelled to undergo medically unnecessary transjugular liver biopsies for research purposes, and that the transjugular research was conducted without inforrnec consent. Examination of the IRB record, InTeam ormocol records (including the subj ects' research !CDs), and the medical records. dld not substantiate any elemer, of these allegations. During the course of our investigation we founc 2 ro,...rrc s... n.,ect cohort of which me whistleblowers were apparently unaware. V, e .:c......... .r.a: ~ aporoval of me modification approving use of control subjects c ·c --::: a:::,a.a~ JJ rreet agenC) expectations. Although control subjects all slg-ec :.~e co..,se • process c c ~o: : : -s 10 VA Response The specific allegation was that the Chief, GI, was performing unapproved human liver research, without informed consent, that places patients at serious risk. Although the whistleblowers alleged otherwise, the Chief, G I, did not conduct unapproved research; he had received IRB approval to conduct the lnTeam research protocol. In addition, the InTeam study staff sought and recejved documented informed consent from study participants. Furthermore, the review found no evidence that the lnTeam research procedures (use of surplus biopsy tissue, and collection of blood , urine, and fecal samples) placed patients "at serious risk." With respect to the concerns involving use of transjugular biopsies in research, one of the whistleblowers became aware of the InTeam research protocol as a conseouence of her service as Upon concluding the SRS review, t e w 1st e ower in ependently conveyed her concerns regarding the lnTeam research protocol to the IRB. The IRB acknowledged the concerns raised by her, and withheld approval of the lnTeam research protocol until th e investigator responded to the concerns to the IRB's satisfaction. 5 By acknowledging these concerns and wri.hholding approval of the protocol until the IRB's concerns were addressed, the Medica Center did investigate the concerns raised about the research study, and did no ap~"'O.e the study until all concerns had been addressed. '/As repo~ referenced, in "Conclusion for Allegation 1," weaknesses concerning '"e:Jea:ec ;a...ure to refer post-lRB approval concerns about the research study to the ~.3 = - --e --eferral omissions appeared to represent a programmatic weakness, and as 7 s._ -- ::-s ~c~ received a corresponding improvement recommendation. OSC Question 6 :; CG.Se explain the validity of consents obtained by untrained or unapproved study ==::-~re raters. It is OSC's understanding that a minimum requirement of informed ::::rse... t is IRB approval of the individual administering the consent. ~Response ~-.....:;__ ~..,a oca. practice, there is no Federal or VA policy that req1.i·res ·1RS a""C-~ro c l o:me ,ndMduaf administering the consent.ff The only agency requirement, found m Vr.A Handbook 1200.05(2) paragraph 29.f(1 ), is that, "If the investigator does not personally obtain informed consent, the investigator must delegate this responsibi lity in writing 5 6 7 The IRB has regulatory and policy requirements to ensure that approval criteria are met. The IRB must determine that approval criteria are met before granting initial approval. The IRB must also conduct continuing review of research at intervals appropriate to the degree of risk, bu1 not less than once per year. The IRB made required determinations and conducted continuing review of the lnTeam protocol as required. After establishing that the approval criteria were met, there is no regulatory or policy requirement that would have compelled the IRB to withhold approval based on the SRS Chair's private concerns. Conclusions for Allegation 1 "The Medical Center leadership did not document the process or findings from an investigation into the Director, Liver and Transplantation Clinic's concerns regarding the unethical conduct of research by the Chief, GI. They also did not refer the allegations for investigation to the IRB and Research and Development Committee." "Recommendations to the Medical Center: 3. Medical Center leadership should develop a formalized plan for addressing complaints of research improprieties and communicate this plan to all staff. The plan should include a process for following up with individuals who have chosen not to remain anonymous." 9 specifically describe sharing of these samples and disclosure of sample collection dates with the academic affiliate. Consequently, we instructed the IRB to amend the ICD to reflect that specimens and PII (the sample collection dates) would be provided to the academic affiliate. These findings concerning the control subject cohort represent IRS and investigator errors that require correction. However, our discovery of these errors does not substantiate the specific allegation that the lnTeam study staff compelled active liver disease a nd alcoholic hepatitis patients to undergo transjugular liver biopsies for research purposes, or the related allegation that they did so without proper researchrelated informed consent. As recommended in the report, the IRB subsequently reviewed the ICD used to enro subjects at its September 28 and October 26, 2017 , convened meetings. The IRB concluded that the ICD adequately described where they were sending specimens and PII. The ICD described that researchers were providing specimens and PII to sites within the In Team consortium , and the affiliate university was an In Team participating site. Nonetheless, the IRS required an amendment to the ICD to explicitly inform subjects that the affiliate university is a participating lnTeam site. - 7e IRB determined that subjects already enrolled did not need to repeat consent with ::-s ... odated ICD. as the changes do not reflect an increased risk to subjects, and s....:)~~ •,ere previously informed that their samples and PII would be provided to --sa.- :)c.icipating sites. - ~: - --:: - -:s ·RB determined that the researchers had not implemented the dietary ~ =-~--..a.~ ::.: ......cS arid it was subsequently removed from use in the protocol. ·on 8 - -~ --=::-:;- '""C,es that the approved consent process included provisions for assessing ~ , :::c:::-.a.:::::- ','/as this provision exercised fo r any patients included in the =--:- :::,:.,;.:~.. ~TIC · -s~ cogflitive evaluations performed at the time of consent per the :::-,2-::-- ::: -Sc.Sc :: sc-_ss:::, s ._, ·gnt of the finding that consents were ooraired b J =~ -: ~=. :o.J.: -a~-. -.o laCKed proper training and approval. A Response Yes. ihe researchers exercised this provision for one participant enrolled in the "active" study arm in October 20 14. The subject had alcohol-related dementia, and research records reflect an assessment of decisional capacity. It was determined that the subject lacked capacity and his legally authorized representative provided consent. Our incidental observations concerning a study coordinator with limited experience did not overlap with this subject enrollment. T he current study coordinator and the Chief, GI , both described a process that involved the direct involvement and assessment of potential subjects for the active study arm by a study physician. 11 OSC Question 9 Please expla in the need for inclusion of information related the background of 'Whistleblower 2." While not incorrect, the report does not include the fact that, at the time , Whistleblower 2 possessed more relevant experience and knowledge than most of the members of the IRB, making reliance on Whistleblower 2's recommendations entirely appropriate, barring consultation with outside experts. (For example, it is our understanding that the Assistant Chief of Staff of Research holds a Ph.D. and does not perform any human research , and the Research Compliance Officer holds a Ph.D. but has been out of the laboratory setting for over a decade and has no human research experience.) VA Response As noted in the report, the IRB did not seek out appropriate, nonconflicted, clinical providers to evaluate this protocol as consultants. The research experience of the SRS Chair was hetoful in identifying potential problems with the initial protocol version. - o•.-.ever. as m·s :::>erson is not a clinical expert, the IRB could not satisfy the --ec-·""e-e-· to a,Jg,...,e,..,1 -rs exper.ise t.· iroug'l consultations with this individual. The IRB ":J _ -: -.a. e ces ... er...ecree to see consu ~ation fror, an independent clinical provider -- a, :.sre...ce ... .,,._ca:....G i."'e pa~ ar st.o,ecc conorr. A nonclinician possessing a =- : :.:,as ...c: sz ·s-=-, -~ess "'Beu·remen:s. ever vl1h significant experience and • --: o~;s. -:--s ... ss:s:.a_-~ c..- ef o-: S~ ocr tra'IS0 a:--: coortfnator, the current coo:1:·~ mr co~ec -:. a :."'e C'"' ec. G . ~as as ec ~ar to submit referral packets for pa e-iS .•.;)() are rn: e =-g:b:e ~'or .ra.'lSµ~r:. T~is .,.,as purportedly reflected in documentation the whistteblowers orovidec. 1/hife OSC's lener to the Secretary referenced Ms. who has J~ft VA employment, the referral was clearly meant to cover the GI Chief s inappropriate transplant requests to the transplant coordinator, whomever that may be. Thus, the report's failure to substantiate even a portion of this allegation, despite the affirmative statements by the current transplant coordinator, appears to be based solely on semantics. Please address this allega:on appropriately in light of OSC's referral and the witness's relevant testimony. VA Response 'l'/e were unable to substantiate the allegation, not because we .·,e e u'laZ e ;r -·5- -= Ms.but because the Chief, GI , explained that his rationa.e ror s_:)~:::;-; patients to VHA, despite them not meeting all of the transplant criteria. Nas ~ ..~~ believed the reviewers at the transplant facilities were more qualified to ma e a determination about the Veteran 's eligibility for transplantation. He further be e .. ac :-c: the Veteran could possibly meet the criteria during the time rt would take (4-6 mO/"'~ s to work up the referra l. He did not want the patients' referrals delayed al the ,. edica Center while waiting for each element of the referral to be satisfied. The current ..::-se -= 12 Practitioner Transplant Coordinator (NP) did not confirm that the Chief, GI, routinely directed her to minimize the need for transplants when talking with patients and their families, or directed her to assemble transplant requests to VHA in a "way to be rejected." On the contrary, the NP believed that the Chief, GI, would approve Veterans for transplant referrals that clearly did not meet the criteria, as she believed those referrals wasted time and resources. OSC Question 2 Please explain the report's finding that the Chief, GI, is providing appropriate care options to patients in light of the fact that the Chief, GI, did direct curtailment of EGO every 6 months for patients with HCV and A cirrhosis. This failure to substantiate a • oears to only make sense if the Chief, GI. does not see patients n~se1~ as ~r-sproviders have ignored this direction. VA Response W e consulted with GI experts within VA and they explained that there are varying schools of thought on the approach and treatment of Hepatitis C Virus and although guidelines exist, the clinician must take into account their assessment of the individual patient and make clinical decisions based on the information available to them. In light of the varied professional opinions, the GI section reviewed , discussed, and agreed on practice guidelines for the Medical Center. The Chief, GI, follows these practice guidelines, noting that each patient's medical condition must be taken into consideration when developing treatment plans. Licensed physicians are expected to use their clinical expertise and skills, in conjunction with established practice guidelines, to determine appropriate medical care. OSC Follow-up Questions - Scheduling and Computer Access Issues SC Question 1 -~~ ='co~ aopears to conclude --:--: _:3e. c, r,ica;_ reviews of all that the Chief, GI, (or another qualified provider) consults submitted to non-clinical staff to be ~ i:::... -e __ osec The report indicates that least one of these employees was _ s_~ ~3 -:: -e:.-e- &.~ ::- -cal re :e ~s were completed_ However. the report does - :- s:a.::~ • .,..eu"iei ,nvestigators conducted a review of a sample of such consults to -E:~....., ~e IT clinical reviews had occurred, particularly in those cases where the '";::onsutts were no longer appropriate." Please provide a basis for the report's celermrnation, other than Chief, Gl's statements, that all consults received appropriate dinical review. ~=-- VA Response The Medical Center's electronic consultation system does not have a method to track an employee's footprint unless that employee creates documents in the record. The review we conducted showed that non-VA providers in the Veterans Choice Program had seen the patient months prior and the consultations, while completed in a timely fashion, had not been documented within the medical record , which would have simplified efforts of administrative closure. 13 OSC Question 2 Please directly address the confirmed lack of candor on the part of the advanced MSA, research assistants, and GI fellows regarding whether the Chief, GI, used his log-in and EHR [electronic health record] to allow them computer access. a. The report notes that the Chief, GI, was reprimanded for this behavior. Please provide the date of the reprimand. b. Please provide a discussion of whether the behavior of the Chief, GI , constituted a HIPAA violation. VA Response The advanced Medical Scheduling Assistant, research assistants, and GI fellows we interviewed stated that the Chief, GI , did not allow them to use his log-in for them to access any patients' medical record. We interviewed employees who currently hold those positions; however, several names provided by tfle whisfleblo vers are no longer employed at the Medical Center and cannot be r.:.er.fe -ec_ By his own admissio,.., ......e O·•e: G a o •,-ec. a-=::,_:: e---:;-records a~er I!'e Cr-e: '1aC cggec c~ ::J :.'"'e :o-__ ::;" OSC Fo low-up Questo - A.:l:: -~-a lSs-es Ra..se-:: OJ OSC Ques ·o 1 _.,..,..·e..,,.... = .::: -:: --::~..,,, --~ a~ .._,..;..,,.,,_,.. ---....._G,. ~--- ~ ---~- ---.,...::,,r with ~4 ..., ......,.' .:::u-....,, c ~.... --= --:::. ~- : u .~ ·""teM·ews ., -.c ~ e ·ne GI e,- c:7s ::..~a.:.,"' :.c ._~ -.£, -~-ee'ling/surveillance for HCC ir- v<:!e-rars .... ... caccr--?ensatec Cf"T"">:)S s ..... ·o a::;cr of . ..;co guidelines, and the failure to transfer patient nformation :o,. pane"'is re;e7ee :or fiver tumor treatment. --i::; , 1 • ir.. ~G