Taken from North Jersey Record
By Lindy Washburn
February 27, 2019
Lindy Washburn explains new federal findings about a deadly viral outbreak at the Wanaque Center.Lindy Washburn and Paul Wood Jr., North Jersey Record
Inspectors initially blamed poor hygiene for the spread of a virus that killed 11 children at a Wanaque nursing home last fall, but a federal report says the larger problem was that those in charge of the facility didn’t plan for such an outbreak and didn’t respond fast enough when it struck.
Most disturbingly, the report describes the pediatric medical director of the Wanaque Center for Nursing and Rehabilitation as so disengaged that he didn’t know how many children were infected, or what exactly his job entailed.
That doctor — not named in the report, but identified through records as Dr. Maged Ghaly — admitted to inspectors that he was barely aware of the burgeoning crisis until it was well underway.
“I knew we had a problem after the fourth death,” he told inspectors, according to the report. But it took five more weeks — and the deaths of seven more children — before one of the nation’s deadliest long-term-care outbreaks was brought under control.
The deficiencies in leadership “contributed to the delay in identification and containment of [the] adenovirus outbreak, affecting 33 residents [and] one staff, and resulted in 11 pediatric resident deaths,” the report said.
Adenoviruses typically cause only a cough, cold, conjunctivitis or urinary tract infection, but the strain that struck Wanaque — adenovirus 7 — was especially severe. And patients like the children at Wanaque, who relied on ventilators to breathe and, in many cases, tubes into their stomachs for nutrition, are particularly vulnerable.
No new cases of adenovirus have been reported at the center since Nov. 12, but the state still bars new admissions to the pediatric ventilator unit, pending approval of the center’s recently submitted infection-control plan.
The center’s administrator, Rowena Bautista, has challenged the findings of the report by staff from the New York regional offices of the Centers for Medicare and Medicaid Services, calling them “unfounded allegations.”
“We are infuriated that, after a cursory review, federal surveyors put together a report riddled with factual inaccuracies, disregard of medical judgment, and blatant misstatements about how viruses spread,” she said in a statement. The center has appealed the report’s findings, she said, “and will vigorously dispute the allegations.”
An infectious disease specialist hired by the center at the direction of the state Health Department said the “outbreak itself was unavoidable, and its scope and consequences were attributable to a particularly dangerous strain of virus that afflicted a very vulnerable population.” The statement was issued by Dr. Edward J. McManus of Infectious Disease Care, a New Jersey practice with 40 physicians.
The 114-page federal report, written Nov. 17, and the facility’s plan of correction, written Jan. 31, were obtained by NorthJersey.com and the USA TODAY NETWORK New Jersey.
The inspectors visited the Wanaque center Nov. 13 through 17, at the peak of the outbreak. Thirty-three children had already been diagnosed, 11 had died and an unknown number were in area hospitals being treated.
The inspectors wrote that everyone living at the Wanaque center — not only those in the pediatric ventilator unit, but another 150 people — was in “immediate jeopardy of contracting adenovirus infections, with the likelihood to cause serious harm, impairment or death.” The center has 92 beds for children and 135 for elderly residents.
The mere arrival of the federal team was unusual, experts said, because surveys of long-term-care facilities are usually delegated to the states. The state already had inspected multiple times and stationed a staff member from its communicable disease service at the center.
The federal inspectors found six “immediate jeopardy” citations, denoting the highest level of concern for government regulators, whose agencies provide most of the revenues for long-term care. Such citations can result in termination from participation in Medicare and Medicaid programs if not corrected, as these have been.
“That’s an extremely high number of ‘immediate jeopardies,’ ” said Richard Mollett, executive director of the Long Term Care Community Coalition, a non-profit based in New York that analyzes federal data and advocates for nursing home residents. Only 5 percent of the deficiencies cited each year by nursing-home regulators rise to that level.
The inspectors cited the Wanaque center’s administration for systemic failings that went well beyond hand-washing and housekeeping.
Disengaged medical director
By law, a nursing home medical director is required to oversee medical policies and procedures at the institution and coordinate residents’ medical care. He is the clinician responsible for medical care at the center.
When nurses notice a change in a patient’s condition and need a doctor’s orders to give Tylenol or antibiotics or transfer the patient to a hospital, they must call the patient’s doctor. For the children at Wanaque, that doctor was the pediatric medical director.
The doctor is not required to be physically present at the nursing home, even when the facility’s residents include such medically fragile children as those at Wanaque.
Medical records show that Maged Ghaly, a Jersey City pediatrician, filled that role, although the inspection report contains no names.
His lack of involvement in the nursing home’s operations resulted in one of the six immediate-jeopardy violations. Only six nursing homes in the United States received the same citation last year.
It was not Ghaly’s first encounter with regulators. Last June, Ghaly settled an investigation by the Office of the State Comptroller’s Medicaid fraud division into overbilling by his office by paying $42,000.
Ghaly declined to comment when reached by phone Friday, citing the advice of his lawyers.
In November, he told federal inspectors he had been at the Wanaque center for 11 years and had “a background” in pediatric intensive care. “I was one of several pediatricians and now I’m the only one left. They all bailed on me,” he said, according to the report. “When they asked me to be the medical director, I agreed. No one gave me a job description and I signed the contract.”
He said he had never been given and had never read about the responsibilities or requirements of a medical director: “I didn’t understand what medical director meant.”
As to the virus, “I thought the state was over-reacting,” he said. “I said, how is it going to spread? That was in October.” But after learning on Oct. 8 what the cause of the infection was, and that four children had died, he told inspectors, “I agree 100 percent that we need to tighten up our process for infection control.”
The Wanaque center’s administrator conceded to federal inspectors that Ghaly had been disengaged.
“He has not been involved in the facility’s infection control surveillance,” she told inspectors. “I have been here four years and have never received a monthly report from him. We have not had formal meetings to discuss issues with the children on the unit.”
Even the center’s director of nursing hadn’t known until August that Ghaly was the medical director, with all the responsibilities for institutional policy that involved, she told inspectors.
No plan for an outbreak
In violation of federal regulations, the administration also failed to make plans for how it would handle a potential outbreak, the inspectors wrote. Administrators weren’t ready when the infection struck: They hadn’t figured out in advance what space, equipment and staff they would need in such an emergency. They hadn’t identified what was already in place.
Such plans are not optional. They are required of all 15,000 nursing homes across the country.
Nor are they irrelevant. If administrators had planned, they might have been able to physically isolate the sick patients from those without symptoms before being ordered to do so on Nov. 14, and thus prevent the spread of the virus from one roommate to another.
The absence of a plan “contributed to the delay in identification and containment” of the virus that eventually led to the hospitalization of 34 residents of the center and the deaths of 11, the report said.
No tracking of infection rate
The uptick in respiratory infections should have triggered an institutional response. But federal inspectors cited a lack of infection surveillance and reporting that kept the staff and administration from seeing the big picture of the outbreak until it was too late.
The administrator told inspectors she had not received data about the infection rate within the facility from the “infection-control nurse.” That nurse hadn’t received certification in that specialty and spent only two to four hours a week on that task.
And the pediatric medical director told inspectors, “I have not participated in the surveillance of infection control and I can’t give you any numbers.” He said he could tell when an unusually high number of his patients had pneumonia, but “I have no formal method of measuring the pneumonia rate or infection rate. I have never been shown the Infection Control report and I am not aware of the facility acquired infection rates.”
This “system failure” led to delays in identifying, reporting and controlling the outbreak, the inspectors wrote.
The federal report also faulted the nursing home for its failure to provide “timely interventions and care in accordance with professional standards,” and failures of two management committees that were to have been responsible for identifying problems and carrying out plans to correct them.
In addition, it detailed filthy conditions in the kitchen and described a complete lack of stimulation for five children who were left in bed for up to eight hours at a stretch during the four consecutive days inspectors observed.
The weeklong federal inspection overlapped with an inspection by surveyors from the New Jersey Department of Health for two days, Nov. 13 and 14.
The state inspection focused on hand-washing and infection-control practices of nurses and certified nursing assistants, the poor condition of bed frames, ventilator carts, heating units and recliners, and delays in cleaning the rooms of virus-stricken patients who had been sent to hospitals and died.
The state inspectors’ findings were so troubling that on Nov. 14, Dr. Shereef Elnahal, the state health commissioner, curtailed all admissions to the center and ordered the facility to hire two consultants: a certified infection-control practitioner and a physician specializing in infectious diseases.
He also ordered the nursing home to “cohort” the patients — separate those who were ill from those who had no symptoms. Those steps, which could have been included in the sort of emergency plan the facility didn’t possess, appear to have finally stemmed the outbreak; no new cases were reported subsequently.
At the time, Rowena Bautista, the nursing home administrator, issued a statement: “Nothing in the [state] report identifies systemic deficiencies in policies or procedures, and there is no suggestion that the deficiencies identified contributed to the viral outbreak.”
Wanaque administrators gave the federal inspectors “acceptable plans” on the spot in November to fix the immediate problems the inspectors identified, the inspectors wrote. That eliminated the need for drastic regulatory action, such as a financially crippling reduction in government reimbursements.
On Jan. 31, the center submitted a more thorough plan of correction. Ghaly, the pediatric medical director, had been “re-educated” about his job requirements, the center said. But it added that he “was involved in clinical oversight of the viral outbreak,” and had given “medical input” and support to the administrator.
A penalty of $20,965 for each instance of infection-control deficiencies was imposed on the Wanaque center by the federal Centers for Medicare and Medicaid Services this month, at the recommendation of New Jersey health officials.
“The plan of correction has been accepted and was followed by an on-site visit to ensure full implementation,” said Danielle Liss, a spokeswoman for the federal oversight agency. After a January inspection, the state found the center to be in compliance with state and federal regulations.
The center’s owners — Daniel Bruckstein and Eugene Ehrenfeld — have retained former U.S. attorney Paul Fishman to represent them. They have never spoken publicly about the outbreak.
“While the outbreak was a tragic event that has left us all heartbroken, it was not caused by any delayed treatment or any other unfounded allegation contained in the [federal] CMS report,” Bautista, the administrator, said Tuesday in her statement.
McManus, the infectious disease specialist who was retained as a consultant, also defended the nursing home. “Based upon my experience and my evaluation of the facility, I believe that [its] policies and procedures in the area of infection control, medical oversight, and quality assurance were comparable to those of other similar settings and facilities,” he wrote.
The children’s deaths “were caused by an insidious and slowly incubating virus that hit a particularly vulnerable population; they were not the result of deficient policies or inadequate care by the facility,” he said. The federal report’s assertions, he said, “are not supported by any evidence and are, in my opinion, incorrect.”
Neither Wanaque’s owners nor its administrator attended a hearing held by the state Senate Health Committee on Dec. 3 to examine the outbreak and consider possible legislative actions to prevent future tragedies like it.
One lawsuit has been filed by the family of a 15-year-old boy, William DelGrosso, who was hospitalized in critical condition but survived the adenovirus outbreak, and more are expected to follow.
When William’s mother entrusted his care to the Wanaque center, said her lawyer, Paul da Costa, she did so “with the sincere belief that she was doing the best thing medically for her son, and that he would receive appropriate medical care from qualified medical professionals.”
“Unfortunately,” da Costa added, “the Wanaque center betrayed my client’s trust.”