Newark Beth Israel Medical Center’s heart and lung transplant program was putting patients in “immediate jeopardy” before the hospital began to implement corrective measures, according to federal regulators.

In a pair of reports sent to the Newark, New Jersey, hospital on Dec. 12, the Centers for Medicare and Medicaid Services found that the transplant program repeatedly failed to fix mistakes. Spurred by ProPublica articles, the CMS investigation uncovered a series of incidents in which the hospital identified areas for improvement following botched surgeries but didn’t carry out its own recommendations, allowing “subsequent adverse events to occur.”

As a result, CMS determined that patients were in “immediate jeopardy,” which is the regulator’s most serious level of violation. It is invoked when “noncompliance has placed the health and safety” of patients “at risk for serious injury, serious harm, serious impairment or death.”

Newark Beth Israel spokeswoman Linda Kamateh said in a statement that the hospital does not agree with all of CMS’ findings, and that they did not warrant the “immediate jeopardy” designation. It will send a letter identifying “certain objections” to CMS, she said.

In particular, Kamateh criticized findings that attributed adverse events to “compliance failures in the transplant program.” CMS’ survey team, she said, lacks the “evidence, expertise and experience” to assess and diagnose patient outcomes. “Root cause analysis is a complicated exercise requiring much more extensive training, and much greater analysis than is reflected” in the CMS reports, she said.

On Dec.15, three days after the hospital received the findings, it submitted a plan to remove the “immediate jeopardy” label by making certain policy changes, Kamateh said. The New Jersey Department of Health, which works in coordination with federal regulators, determined that those measures were enough to lift the designation, according to the hospital and CMS.

CMS also required the hospital to submit plans of correction, which are “under various stages of review and implementation,” Kamateh said. As part of the plans, which the hospital shared with ProPublica, Newark Beth Israel has created a transplant steering committee to oversee the transplant program. Staff responsible for quality review in the transplant program will report directly to hospital management and not to the program’s leaders.

Nevertheless, the hospital remains out of compliance with federal rules for quality assessment and performance improvement, surgical services, and patient rights, as well as special requirements for transplant centers, according to a CMS letter to the hospital on Jan. 12. In the letter, CMS warned Newark Beth Israel that, unless the issues are resolved by March 21, it will take steps to terminate the hospital from the Medicare program, which means the federal insurer would end reimbursements for Medicare patients. Medicare primarily insures people who are 65 or older.

CMS’ December reports also cited violations of patient rights, including failures to obtain informed consent and to seek information from patients and family members on advance directives such as do not resuscitate orders. Although the reports do not identify patients or doctors by name, surgery dates and other specifics indicate that at least two of the cases were those brought to light by ProPublica articles last year.

CMS’ findings may help to explain why the heart transplant program’s one-year survival rate fell to 84.2% in 2018, well below the national average. The concern for statistics prompted the transplant team to keep Darryl Young, a patient in a vegetative state, alive without offering palliative options such as hospice care to the family, ProPublica reported last October.

Besides CMS and the New Jersey Department of Health, the FBI and New Jersey’s Board of Medical Examiners are also investigating the hospital in the wake of ProPublica’s reporting. Newark Beth Israel has placed Dr. Mark Zucker, the head of the transplant program, on administrative leave while it conducts an internal investigation.

Legislators are seeking answers as well. On Jan. 14, citing ProPublica’s “concerning reports,” three members of New Jersey’s congressional delegation asked CMS how it planned to hold Newark Beth Israel “and other programs that may engage in similar behavior” responsible and improve oversight “to ensure that this does not happen in New Jersey or any other state,” according to a letter obtained by ProPublica.

“This lack of transparency, compassion, and communication” in the cases exposed by ProPublica “was cruel,” wrote U.S. Sen. Robert Menendez, and U.S. Reps. Bill Pascrell Jr. and Donald M. Payne Jr., adding, “Both cases show a serious breach of the trust we place in health care providers and a clear violation of the Hippocratic Oath.” CMS is working on a response, according to a spokeswoman.

The CMS reports focused mainly on Newark Beth Israel’s heart and lung transplant programs, though one case involved patient safety in a psychiatric unit. Newark’s heart program is one of the 20 largest in the country by volume, having transplanted more than 1,000 patients over the last three decades. Its lung transplant program is smaller.

Three patients suffered brain damage within a seven month span, apparently due to similar causes, according to the reports. In March 2018, a patient suffered a “neurological deficit” after a heart transplant operation. The hospital’s own outcome report recommended a review of its blood pressure monitoring equipment, but CMS couldn’t find evidence that any review took place. Less than a month later, another heart transplant patient suffered a “severe neurological deficit” during surgery. The outcome report gave the same recommendation. Again, CMS found no review occurred.

Then in September 2018, Darryl Young suffered brain damage during his heart transplant and never woke up again, ProPublica reported last year. CMS found that an unnamed patient — whose surgery date matches Young’s — had a heart transplant resulting in “altered mental status.” The hospital’s outcome report recommended more frequent blood pressure monitoring, but CMS said it was unable to find evidence that staff were educated or that the change was implemented.

Before and after Young’s surgery, in August and October 2018, a heart transplant patient and a lung transplant patient suffered complications during their operations that resulted in kidney failure. After the first incident, the hospital recommended increasing the frequency of blood pressure readings. In the second incident, the hospital report said the complication was “likely due to hypotension” — low blood pressure — in the operating room, and recommended monitoring for future occurrences. CMS said it could not find evidence that the recommendations were implemented.

Other improvement suggestions were also ignored. In January 2018, after a heart transplant patient died after surgery, the hospital’s outcome report recommended having “a 2nd surgeon available for difficult and prolonged cases.” The following May, after a complication occurred in another heart transplant operation, a similar note called for a “plan to encourage transplant physicians to ask and offer assistance for difficult and lengthy cases.” However, CMS said it found no evidence that Newark Beth Israel educated its physicians to do so.

ECMO machines, which temporarily replace a patient’s heart and lung function by pumping and oxygenating blood outside the body, malfunctioned during a lung transplant in December 2018, CMS found. The patient wasn’t harmed, but the hospital noted it was a “near miss event” and recommended using what is known as a primed cardiopulmonary bypass machine in the event of problems with ECMO machines. “Perfusionists will be informed,” the note said. However, CMS said it found no evidence that perfusionists — who operate bypass machines — were told. Then, the following February and April, ECMO equipment issues led to two other mishaps during lung transplant surgeries. The first patient ended up with a “neurological compromise,” CMS found, and the second died in the operating room.

As part of its plans of correction, Newark Beth Israel said it has implemented a policy that makes sure backup equipment is available for any transplant procedure that involves an ECMO. It has has educated all perfusion and anesthesia staff, it said. It is also planning to review and monitor its blood pressure equipment, with the anesthesia department observing all transplant cases to make sure the equipment is properly placed “until 100% compliance has been achieved for three consecutive months.”

In total, CMS detailed 10 “adverse events” from January 2018 to April 2019. As ProPublica reported last year, the heart transplant team became worried that its slipping survival rates — specifically, the proportion of patients who reached the one-year anniversary of their surgeries — would attract federal scrutiny. Zucker said at a staff meeting in May 2019 that Darryl Young “unfortunately became the seventh potential death in a very bad year, all right, and that puts us into a very difficult spot,” according to an audio recording of the meeting obtained by ProPublica. Treating Young aggressively without offering other options to the family, Zucker said, “is a very, very unethical, immoral but unfortunately very practical solution, because the reality here is that you haven’t saved anybody if your program gets shut down.”

Young’s sister and health proxy, Andrea Young, had told ProPublica that she felt doctors at Newark Beth Israel were “hiding something” from her, that her brother’s prognosis wasn’t fully explained to her and that she wasn’t asked about her goals for his care until 10 months after his transplant surgery.

CMS’ report corroborated this lack of candor. In the case of an unnamed patient, whose details, including transplant date and hospital admission date, matched Young’s, the federal inspectors found that physicians wrote information including “prognosis is not great” in medical records in March and “overall prognosis is poor” in June. But CMS found no evidence that the patient’s next of kin was given this information.

CMS located a social worker’s note that Andrea Young had requested weekly updates on her brother’s condition. The medical record “lacked documented evidence that the physicians contacted … next-of-kin on a regular basis, or a weekly basis as requested, regarding the progress of the patient,” CMS said.

The hospital “is developing and will implement a standard for communications with patients and their authorized representatives,” according to its plans of correction. Its spokeswoman, Kamateh, said medical records show that doctors and staff communicated repeatedly with Young’s family and that family members “were contemporaneously informed of his status, his expected clinical trajectory, and his treatment options.”

Told of CMS’ findings in her brother’s case, Andrea Young said in a statement: “It is my hope that NBI’s Transplant Unit will implement the appropriate corrective measures to address the many existing deficiencies that plague their transplant program. Trust is especially paramount in the medical profession and restoration of that trust is essential to every patient and every family.”

ProPublica reported in December on Andrey Jurtschenko, a heart transplant recipient at Newark Beth Israel who suffered brain damage during his operation. In earlier conversations, Jurtschenko had made clear to his children, Chris and Megan, that he didn’t want to be a burden on them. The children told ProPublica that, when they sought a DNR order for their father after his surgery, they were initially rebuffed. The family continued to press the issue and secured a DNR more than a month after his surgery.

Again, the CMS investigation bore out the family’s concerns, though it focused on a later incident when Jurtschenko was readmitted to the hospital from a rehabilitation facility. Describing a patient whose details — including transplant surgery and other procedure dates, as well as quotes from medical records — matched Jurtschenko’s, CMS found that Newark Beth Israel violated its own policy on advance directives. The hospital’s policy states that “an inquiry will be made of each adult patient, at the time of admission … concerning the existence and location of an Advance Directive for Health Care. If the patient is incapable of responding to this inquiry, the medical center will ask the family or person with knowledge of the patient.” Yet, when the hospital admitted Jurtschenko, it marked “NO” in his paperwork to the question of whether he had an advance directive, even though his children, who were his health proxies, would have requested a DNR order if it had consulted them.

Kamateh said that families “make these very personal decisions following a dialogue with the clinical team taking into consideration the best medical advice,” adding, “Mr. Jurtschenko’s medical record confirms that his family’s decision to implement a DNR in June rather in April did not change his outcome.”

CMS also found that Newark Beth Israel “failed to ensure a patient’s right to have a family member notified of his/her admission to the hospital” because it had admitted Jurtschenko to the hospital from the rehabilitation facility without informing family members.

The hospital will train staff in obtaining information about advance directives, health care proxies, and surrogate decision-makers, according to the correction plans.

In a reference to ProPublica’s reporting, CMS found that hospital staff members violated patients’ rights by sharing patients’ information with a journalist “for purposes other than treatment, payment and health care operation.” It noted that Newark Beth Israel had an internal compliance hotline and ethics consultation team, which did not receive any complaints or reports of concerns regarding transplant patients.

Unrelated to the transplant program, CMS also found that a 14-year-old patient was left unsupervised in October 2019 in the presence of an adult patient “with a history of aggressive, violent and erratic behavior,” according to the report. The minor, who wanted to use the bathroom, was brought there by a staff member and left there. Afterward, she told the staff that “a patient walked into the bathroom and kissed” her. The incident violated a patient’s right to receive care in a safe setting, CMS said.

Immediately after the incident, Newark Beth Israel interviewed the patient and notified the parent, the Newark Police Department and the New Jersey Division of Mental Health Addiction Services, according to the hospital. According to its correction plans, the hospital has adopted a new policy to minimize contact between minor and adult patients in its psychiatric emergency screening services unit. “Policies around the monitoring of minor patients were immediately strengthened,” Kamateh said.