DEPARTMENT OF VETERANS AFFAIRS Under Secretary for Health

Washington DC 20420

Mr. Tristan Leavitt Acting Special Counsel U.S. Office of Special Counsel 1730 M Street, NW, Suite 300 Washington, DC 20036

October 7, 2017

RE: OSC File No. Dl-16-5687/88/89/90

Dear Mr. Leavitt:

I am responding to your July 26, 2017, email request for supplemental information on the Manchester Department of Veterans Affairs Medical Center, Manchester, New Hampshire, about which you asked 15 specific questions. The enclosed supplemental report answers your questions.

If you have any other questions, I would be pleased to address them.

Enclosure

Sincerely,

Carolyn M. Clancy, M.D. Executive in Charge

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Department of Veterans Affairs Supplemental Report to the

Office of Special Counsel OSC File Number Dl-16-5687/88/89/90

Manchester VA Medical Center Manchester, New Hampshire

October 4, 2017

At the direction of the Secretary of the Department of Veterans Affairs (VA), the Under Secretary for Health directed the Office of the Medical Inspector (OMI) to assemble and lead a VA team to investigate allegations lodged with the Office of Special Counsel (OSC) concerning the Manchester VA Medical Center (the Medical Center), Manchester, New Hampshire. The whistleblowers, who chose to remain anonymous, alleged that employees are engaging in conduct that may constitute violations of law, rule or regulations, and gross mismanagement, an abuse of authority, and a substantial and specific danger to public health. The team conducted site visits to the Medical Center on February 6-8, 2017, and the VA Boston Healthcare System (Boston HCS) on February 8-10, 2017. VA submitted its report on June 9, 2017.

On July 26, 2017, OSC emailed a request to the Department for a supplemental report to address 15 specific questions related to VA's June report. OSC's questions, divided and numbered for each category, and VA's responses follow:

Conduct of the Investigation

1. Why wa'--.__,.R __ the Chief of SC/ID and Physical Medicine and Rehabilitation Services not initially contacted for an interview? - managed the department that is the focus of this matter, and was not initially selected for interview. Rather, he approached OM/ investigators and identified himself as the doctor in charge of the SC/ID clinic. When interviewed, he was provided 45 minutes of time to discuss 96 patients, and was not subsequently contacted with follow-up questions.

Response: Althoug ~-- was not named in OSC's referral to VA, it was immediately clear from the time we began developing our plan of investigation that it would be essential to

1 interview the Chief of SCI/D. On January 30, 2017, we asked the Manchester VAMC leadership to arrange the schedule for VA's upcoming site visit. We provided a list of staff members (by position or title) that we needed to interview to the facility's designated point of contact; this list included the Chief of SCI/D.

On February 6, the first day of our Manchester site visit, we encountered - during our tour of the SCI clinic and reiterated the need to schedule an in-person interview with him. His interview was scheduled for 1 hour but lasted 74 minutes, during which time he provided a list of patients that included the date that each was diagnosed with myelopathy and a short clinical synopsis of each case. In addition, - provided an overview of SCI/D diagnoses, complications, and treatment modalities; discussed an educational conference that he had organized; and highlighted a few of the SCl/O patients about whose care he had specific concerns . We determined that the list that - provided included enough information to identify each patient, so that no additional information fro ___ was required to undertake

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individual case reviews. The VA team included an SCI/D specialist who was able to evaluate each Veteran's SCI/D care and treatment by reviewing their Electronic Health Records (EHR).

2. Why was _________ not intetviewed? was specifically mentioned in the referral as having hands on experience treating V AMC Manchester myelopathy patients, and had observed serious deficiencies in their care.

Response: It is not VA general practice to interview non-VA employees, particularly when we've determined, as we did in this case, that the available documentary evidence is sufficient. The list of patients provided by - included Veterans that he referred to 1,

and their condition and care (including that provided b ,___ _____ ) were thoroughly ().;,,..L comprehensively documented in the patients' EH Rs. All of the cases provided by - will be reviewed by external, independent non-VA specialists who are experienced in the care of patients with spinal cord injuries and diseases.

3. During inte,views, additional a/legations were provided to OM/ regarding rusty and dirty surgical instruments, the lack of a nuclear camera for cardiology, and a variety of other problems. Why were these issues not addressed or reviewed in the report?

Response: VA investigated the three specific allegations that OSC included in its referral to the Agency. These did not include allegations of dirty surgical instruments and problems with the nuclear camera .

Spinal Cord Care

1. Please provide an update on the status of the 23 cases subject to additional review. (See pages 8 and 9) .

Response: To ensure maximum transparency and objectivity, all of the cases provided b - (not just the 23 cases that VA's subject matter expert had identified for additional scrutiny) are currently being reviewed by external, independent non-VA specialists experienced in the care of patients with spinal cord injuries and diseases.

2. In his intetview, - · reiterated that patient charts were inaccurate due t ~--~ substantiated practice of copying and pasting chart notes. Given this, did investigators review the cases identified by - · with this in mind, and was any effort made to independently verify the accuracy of these charts?

Response: The medicolegal standard in the U.S. is that information contained in a patient's health record represents the best and most accurate documentation of the patient's condition and treatment at the time the record was made. There is no way to independently verify the accuracy of health record entries that were made in the past. However, our reviewers undertook a comprehensive evaluation of the entire record, including notes from multiple disciplines (not just - ·) documenting each patient's condition at the time of the visit. These included hospitalizations, primary care visits, specialty care consultations, physical therapy sessions, imaging studies, and prescriptions for drugs, orthotics, and assistive devices. To ensure maximum transparency and objectivity, all of the cases provided by - will be reviewed by external, non-VA reviewers experienced in the care of patients with spinal cord injuries and disease.

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3. - noted that these patients were provided with a significant amount of assistive devices, which increased based upon a progressive decline in their function. Did investigators conduct a review of each patient's durable medical supply list to ascertain the progression of their conditions?

Response: Yes. The progressive use of durable medical equipment (DME) was reviewed for the 23 SCI/D patients and 7 Neurosurgery cases identified for additional review in the report. A non-VA external reviewer will review all cases and the progressive use of DME will be included in these reviews.

4. Regarding Veteran 1, the report noted "It is not clear if. worsening tetraparesis was a result of his surgery or the several cervical stenosis and disease progression. " If investigators could not determine if. surgery caused worsening tetraparesis, how can VA conclude that "neurosurgica/ care ... was evaluated and deemed appropriate[?]" (See page 14).

Response: We evaluated Veteran 1 's neurosurgical care for appropriateness of procedure, surgical technique, and post-procedure care. The presence of tetraparesis does not necessarily indicate substandard surgical intervention or care, but may result from disease progression. In this case, we determined that the Veteran's surgical care was appropriate , but we could not say with certainty that would not have developed tetraparesis i did not have surgery. This Veteran's care will also be reviewed by an external, non-VA neurosurgeon.

5. Regarding Veteran 1, the report stated that no signs of infection were found. (See page 11) - · disputed this conclusion. Please directly respond to the following statement regarding this patient:

The committee states that the chart showed no evidence of any clinical signs of infection; however, they omitted findings from the CSF [cerebrospinal fluid], which on multiple occasions afte becoming comatose showed elevated proteins in the 450 range, when normal is 15; demonstrated white cells too numerous to count, with 98-99% of the type associated with an acute infection. In addition, the CSF was known to be cloudy or turbid when normal should be clear. Of note, that there was no bacteria found; however, almost all of the CSF samples occurred after the patient had already been started on IV vancomycin, thus rendering the culture and gram stains done on blood suspect. Another important clinical sign that they failed to mention was the development of bilateral frontal hematoma that occurred between the two CTs of. head shortly after . became comatose. These types of hematomas can be frequently seen when a patient is dropped or through a blunt trauma; however, the patient had been comatose and immobile, so it is unlikely that suffered a blunt trauma and the conclusion can be drawn tha was dropped!

Response: During this Veteran's post-operative care, an Infectious Diseases (ID) specialist at the Boston HCS reviewed . case and concluded :

The Veteran was seen post-operatively on November 2014, by ID because the fluid collection had many white blood cells on gram stain, with no organisms seen. • had already been placed on broad spectrum antibiotics by the primary team when ID was consulted .

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Based on the clinical presentation and negative culture, the ID consultants found no conclusive evidence of infection, but suggested that broad spectrum antibiotics be continued while awaiting final culture results.

The treating physicians continued the antibiotic (vancomycin/cefepime) prescription while ordering additional clinical testing, including bronchoscopy, to rule out other sources o fever. These clinical tests were unable to demonstrate a definite source of infection. The original CSF collected grew coagulase negative staphylococci in the broth culture (signifying very low amounts) of one of the aspirates obtained in the operating room on November IIIIThis was felt to have been a contaminant since the count was very low amount and all other cultures remained negative. The clinical expertise of the treating physicians was that these findings are not consistent with a clinical picture of meningitis. Our clinical expertise agrees. The patient's mental status improved and the treating physicians discontinued the antibiotic prescription 7 days after initiation. The treating physicians continued to monitor the patient closely for any signs of infection.

The patient did well from an infectious diseases standpoint - with no evidence of relapse or recurrence o symptoms, suggesting that the initial assessment of the lack of an infectious process was correct. The short course of antibiotics received would be inadequate to fully treat meningitis, especially with surgical hardware in place.

This event was not consistent with a post-operative infection. The final diagnosis was an inflammatory CSF fluid collection without evidence of bacterial infection.

The VA team's review of this Veteran's care concurs with the ID specialist.

Additional information from the EHR reviewed by the VA team demonstrates a protracted clinical course. Followin surgery in November 2014, the patient displayed signs of an altered mental status including confusion and agitation. In an attempt to determine the cause o continued confusion and agitation, the patient had a CT of head completed on Janua 2015, that indicated the presence of bilateral subdural effusions; there was no evidence of a hematoma.1 On January I , a nurse found the patient on the floor- said that • was trying to reac chair, but instead slid off of the bed and hit forehead on the floor. A repeat CT of head done on Janua revealed that "bilateral subdural effusions (which had been present previously) with no evidence of an acute mass or hemorrhage." The effusions were present before and after the patient's fall. Per these imaging reports, the size of the effusion increased from 11 millimeters to 13 millimeters, bu SCI/D providers and neurosurgeons assessed tha had not experienced any neurological change i condition. Based on the documentation in the patient's EHR, there is no evidence to suggest the patient was dropped.

On January . 2015, at approximately 8:10 p.m., the patient became somnolent, and was unable to answer questions. The Medical Center's Rapid Response Team evaluate and determined tha change in mental status could be due to an infection, delirium, volume

1 A subdural effusion is a collection of cerebral spinal fluid trapped between the surface of the brain and the outer lining of the brain, and is a rare complication of meningitis in infants. A subdural hematoma is a collection of blood that accumulates under the skull but outside of the brain, and is frequently observed after severe head trauma. https://medlineplus.gov/ency/article/001422.htm

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depletion, or metabolic issues.2 • treatment team prescribed intravenous fluids and obtained blood and tissue specimens for diagnostic testing . Two hours late~ returned to previous mental status. There is no documentation in the patient's EHR indicating that • was comatose at any point during this hospitalization, which lasted from October • 2014, until Februa 2015. A non-VA external reviewer will also review this case .

6 . Additionally, the report recommended a review of the care Veteran 1 and Veteran 2 received at Boston HCS, as well as five other individuals. (See page 15). If additional review is required, why did VA state that Veteran 1's neurological care was "evaluated and deemed appropriate?"

Response: The initial reviewers deemed the care appropriate; however, given the complexity of both cases, we concluded that a second review of the care would be beneficial. An independent, non-VA external reviewer will review all cases provided by _ ,_

7. Please provide an update on the recommended review of the seven veterans who were referred for operations at the Boston HCS.

Response: This independent, non-VA external review is included in reviews mentioned in response 6, and is still in progress.

8. Why were investigators "unable to substantiate" that the referral process from VAMC Manchester to Boston HCS creates undue delays in care, despite finding that 11 consult appointments were not made in the required time, and in 6 instances finding no documented reason for the delay?

Response: It is VHA policy that Veterans' appointments are scheduled timely, accurately, and consistently with the goal of scheduling appointments no more than 30 calendar days from the date an appointment is deemed clinically appropriate by a VA health care provider. This date is called the clinically indicated date (CID) .3 Of the 54 consultations referred to the Boston HCS, 11 (20 percent) were not given appointments within 30 days of the CID. Of those 11, two were not available for care within 30 days of the CID (one at the Veteran's request and one due to unresolved eligibility issues), and the Boston HCS was not able reach three Veterans within 30 days of the CID. As stated in the report, we found no documentation to explain why the remaining six consultation appointments (11 percent) were not made within 30 days of the CID. Of these six:

• one patient's appointment was scheduled 32 days after his CID; • one patient's appointment was scheduled 33 days after his CID; • two patients' appointments were scheduled 36 days after their CID; • one patient's appointment was scheduled 41 days after his CID. • one patient's appointment was scheduled 62 days after his CID; this patient needed

additional imaging done before his surgical evaluation could be completed and that imaging was not performed until 32 days after his CID.

2 Rapid response teams are composed of clinicians who are expected to recognize and rapidly respond to significant changes in a patient's condition; this in an attempt to prevent the patient's condition from further deterioration and possible cardiopulmonary arrest.

3 VHA Directive 1230, Outpatient Scheduling Processes and Procedures. July 15, 2016. (https:l/www.va.gov/vhapublicationsNiewPublication. asp? pub _/0=3218)

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Because the vast majority of referrals to the Boston HCS occurred within 30 days of the CID as prescribed, and since only 2 of 54 referrals (4 percent) required more than 36 days, we were not able to substantiate that the referral process creates undue delays in care.

-1. Why was no follow-up action taken for at least 2 years after the initial discovery that _ was copying and pasting chart notes? (See page 18).

Response: It is not clear why actions were not taken to address - inappropriate copying and pasting. We found no documentation addressing the now-retired Chief of Staffs failure to act when he was made aware of this situation.

2. Why were investigators unable to review notes going back before 2008? Per VHA Handbook 1907.01, both paper and electronic VHA health records must be maintained for 75 years after the last episode of care.

Response: We reviewed the audits initiated by the Medical Center in FY 2006 to assess the presence of inappropriate copying and pasting in the EHR. We found evidence of inappropriate copying and pasting in - documentation from 2006 through 2011. Since there is evidence of this physician's inappropriate behavior from at least 2006, we substantiated the allegation that - documentation contained inappropriate copying and pasting. A review of his individual notes from years prior to 2006 would not alter that conclusion.

3. Why did investigators conclude there were no adverse outcomes if they were unable to review the full time period where ___ . was alleged to have copied and pasted notes?

Response: We reviewed the audits documentation that the Medical Center began in FY 2006 and agreed with the conclusion that they revealed no evidence of adverse outcomes. Many of the patients whose records had previously been audited were among those provided by _ ;_ The care provided to all of these Veterans will be reviewed by an external , non-VA reviewer.

Flies

1. the Service Line Manager for Medicine and Specialty Care, was interviewed regarding this issue, and asserted that there were cancellations of GI procedures for colonoscopies. Please respond directly to this assertion - were any of these procedures delayed due to these conditions?

Response: According to recorded testimony during his interview with the investigative team, he said "my only direct knowledge of the OR [Operating Room] is colonoscopy because GI comes under Medicine. I haven 't been made aware of cancelled cases, per se. "

During the early fall of 2014, OR staff members began noticing flies in OR #2 while preparing the room prior to the start of the first scheduled case of the day. The insects were identified as cluster flies . They notified OR leadership and subsequently reassigned the cases scheduled for OR #2 for completion in one of the other ORs. An EMS employee terminally cleaned OR #2 and the room remained closed for 6 consecutive days, during which time OR staff members

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saw no additional flies in the room. OR staff members did not see any cluster flies before, during, or after any surgical procedures in OR #2, but some staff members saw flies there during the late fall of 2014 and following winter of 2014- 2015. The Medical Center did not perform any colonoscopies in the OR during FY 2015.

The Medical Center discontinued use of OR #2 from September 2015 (FY 2015) until January 2016 (FY 2016), and OR staff members saw no additional flies until the fall of 2016 (the end of FY 2016). Colonoscopy data for FY 2016:

• 526 colonoscopies were scheduled • 488 colonoscopies were performed • 38 were cancelled:

o 12 were cancelled by the patient o 11 were "No Shows" (the patient failed to show up for the scheduled

procedure) o 11 were cancelled because of clinical issues (e.g., the patient had an

elevated blood pressure, elevated blood glucose, other abnormal laboratory finding, inadequate colon prep, etc.)

o 4 were cancelled because the provider was unavailable due to illness.

OR #2 has remained closed since the fall of 2016 (the end of FY 2016) while colonoscopies have been performed elsewhere. Colonoscopy data for FY 2017 through June 30, 2017:

• 647 colonoscopies were scheduled • 604 colonoscopies were performed • 43 were cancelled:

o 22 were cancelled by the patient o 9 were "No Shows" o 8 were cancelled because of clinical issues o 4 were cancelled because of the anesthesia provider was unavailable due

to illness

Therefore we found no evidence that colonoscopies were cancelled or delayed because of the presence of flies or the subsequent closure of OR #2 during FY 2016 and FY 2017.

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