The National Institutes of Health is overhauling the leadership of its flagship hospital after an independent review concluded that patient safety had become “subservient to research demands” on the agency’s sprawling Bethesda campus.
The shake-up at the NIH Clinical Center, which was announced to staff Tuesday, represents the most significant restructuring at the nation’s premier biomedical research institution in more than half a century.
NIH Director Francis Collins said he will replace the hospital’s longtime leadership with a new management team with experience in oversight and patient safety, similar to the top structure of most hospitals. He is recruiting for three new positions: a chief executive, a chief operating officer and a chief medical officer. Collins wants all three to be physicians, and he wants them in place by the end of the year.
John Gallin, a clinician-
researcher who has headed the center since 1994, will stay on as director during the search.
“We’re going to cast a wide net and see who we can reel in as swiftly as we can,” Collins said in an interview. “We’re looking outside for that CEO individual, whose focus is not on research but on managing all of the operations of the hospital to maintain the highest quality.”
The Clinical Center, the largest hospital of its kind in the world, sees thousands of patients every year from across the United States and around the globe. Many are desperately ill with rare or intractable conditions, and the facility frequently represents their last and best hope. It provides free, state-of-the-art care as part of studies that have indeed saved lives and led to medical breakthroughs.
“There’s no other hospital like it,” NIH declares on its website.
Five years ago, the center grappled with a superbug outbreak that left seven patients dead. The situation could have occurred at any health-care facility, but part of the criticism leveled at NIH was its lack of public disclosure. Not until a year later did researchers detail — in a scientific paper — what had happened.
Serious as that outbreak was, the problems putting the center under scrutiny now are far more systemic.
Last month, a task force appointed by Collins found that research interests and needs had taken priority over measures to ensure patients were protected. The panel’s bluntly worded review also found that unlike at many hospitals, the Clinical Center had no adequate system for individuals to anonymously report “near misses,” meaning errors in care or problems in treatment that could have caused serious injury.
Moreover, it noted, supervisors failed to appropriately address situations that were identified.
The review, the first in decades, laid much of the blame on NIH’s organizational structure and fragmented authority — and on the Clinical Center’s lack of authority. Although identifying no cases of direct patient harm, it raised troubling questions about the agency’s internal clinical research, which makes up about 11 percent of the overall NIH budget.
“We believe the time has come to recognize that the Clinical Center model needs to evolve and function the way other hospitals do,” Collins said in an interview. While applauding its “fabulous research” and long list of accomplishments, he said management needs to be reorganized and centralized “to more effectively focus on standards of patient safety, compliance and oversight, which have been very difficult to achieve.”
The Clinical Center, which opened in 1953, is where much of NIH’s own research takes place. It sees about 24,000 research volunteers of all ages each year. Only about 18 percent of participants are healthy individuals. About 25 percent have cancer.
During the 2014 Ebola epidemic in West Africa, the hospital cared for Nina Pham, one of two nurses who became sickened with the virus in the United States after an infected man from Liberia traveled to Dallas.
The majority of physicians and researchers conducting studies at the 200-bed hospital are employees of NIH’s 27 institutes and centers; they report to the heads of those other entities, not hospital leaders. Such diffuse authority “makes central decision-making and accountability nearly impossible,” the review said.
The Clinical Center itself has little authority, it added, and “there is no systematic way to monitor clinical practice” across all institutes.
Collins described the new leadership structure as an attempt to address those issues and not a “negative comment” about Gallin and his team. “It’s a vote of no-confidence in the structure that no longer fits the needs,” he said.
The task force was initially appointed last year to look into contamination problems in the hospital’s pharmacy unit, which manufactured drugs for clinical research. A whistle-blower complaint had triggered a probe by the Food and Drug Administration; after deficiencies were found, NIH suspended some operations.
The safety lapses prompted Collins to ask for a broader look at hospital operations and all clinical research that takes place on the campus. The task force included outside hospital executives and was chaired by Norman Augustine, former CEO of Lockheed Martin.
Its report, presented three weeks ago, identified a culture that over decades had allowed patient safety to be overshadowed by a single-minded focus on clinical investigation.
Collins, who has served as NIH director since 2009, said the months-long process that culminated in the 18-page report was “the darkest moments of my time here at the NIH.” Problems at one hospital unit, he said, turned out “not to be an isolated event but also a reflection of institutional failures about compliance and attention to patient safety.”
He quickly outlined a series of actions in response. He appointed one of the outside experts, Laura Forese, chief operating officer at the New York-Presbyterian health system, to head a new board to oversee the Clinical Center’s operations. NIH also created a new compliance office to monitor all of its clinical research and delivery of care.
The actions will cost “tens of millions” that Collins hopes NIH can absorb within its budget.
Patient safety experts say NIH has lagged on the safety improvements taking place at other hospitals.
“I would say the oversight for quality and safety is much tighter outside of research,” said Peter Pronovost, who directs the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Medicine. In research, “that culture still hasn’t caught up,” he said.
When scientists conduct clinical trials to study a particular drug’s effect on patients, they want to know if differences in outcomes are a result of the drug, Pronovost said. But if patients have bad outcomes because of the care they receive, “that could really bias your research findings.” His bottom line: “You can still do cutting-edge research and have safe patient care.”
As a federal facility, the NIH hospital is not subject to the oversight and regulations in place at typical research hospitals. But misunderstandings about which regulations do apply “have led some NIH staff and leaders to operate as though the [Clinical Center] does not need to comply with the standards of a more conventional hospital,” the report said. “This is unacceptable.”
The task force said the problems with the pharmacy development unit were long-standing. Even though staff regularly raised concerns, those concerns were never reported beyond the pharmacy department. There was no formal mechanism at the Clinical Center for staff to report issues outside their chain of authority.
Last June, NIH halted operations at part of the unit after the FDA conducted an inspection following fungal contamination in materials intended for injection. The inspection also found defects in the unit’s air handling system and a lack of compliance with standard operating procedures.
The report concluded that the pharmacy unit was running beyond its physical and personnel capacity. “Responsiveness to investigator requests gradually became de facto prioritized above patient safety,” it said.
NIH also hired two outside companies that specialize in quality assurance for manufacturing to review facilities making research materials intended to be injected or infused into people. That review led NIH to temporarily stop work at two labs last month, one focused on cell therapy production at the National Cancer Institute and the other involved with agents for brain imaging studies at the National Institute of Mental Health.
Collins said he has kept members of Congress informed, providing them with copies of the task force’s report before it became public. On Capitol Hill, there have been no calls for hearings.
Some outside biosafety experts point out that the latest findings became known only because of the FDA investigation. Richard Ebright, a professor of chemical biology at Rutgers University who conducts biosafety research, said NIH needs to be more transparent.
“This is a black eye for the NIH,” he said. “The NIH is the crown jewel of science and technology. The NIH needs to have a safety record, a compliance record, transparency and leadership befitting a crown-jewel organization.”
Correction: An earlier version of this story incorrectly reported the toll from the Clinical Center’s 2011 superbug outbreak. Seven patients’ deaths were directly attributable to the outbreak.