The decision to revise the direction of the National Institutes of Health (NIH) Clinical Center after a group of outside review found serious patient safety issues sparked an outcry at the NIH campus in Bethesda, Maryland. In a recent letter, the department heads to center wrote the review, triggered by problems with a drug production facility, wrongly concluded that patient safety was compromised in the research hospital. They say the report of the Working Group demoralized staff, worried patients, and "demonized" the center director.
letters patient advocates and research at NIH clinicians have also written taking issue under consideration. The NIH Director Francis Collins said yesterday in one of the letters, the clinical department heads Center. In a statement, Collins said he "takes the comments ... seriously. They are very dedicated senior officers, and I have great respect for all of them. "At the same time, it" stand [s] by "the process and expertise outside working group and agreed that the center is" more central authority and responsibility. "Collins was to meet clinical leaders today to discuss their concerns.
disorders is the clinical center began there about a year, when the fungal contamination was found in two vials of a drug from a sterile production unit in the development section pharmaceutical center. Examination revealed other problems at the facility, such as insects in lighting. Although no patient was injured in December 2015 Collins asked a so-called red-Team Working Group of its Advisory Committee to the Director to review all of the Clinical Center. The team on April report found "significant operations issues" with patient safety, regulatory compliance, and leadership. He describes a culture where patient safety "has become enslaved to search requests."
In response, Collins announced several changes, including a new board of the hospital. And the May 10, he said that the clinical team Centre Director John Gallin would be replaced by a new management structure similar to that used by most hospitals: a CEO, COO and the head doctor. Gallin the team will remain in the changes, Collins said.
But the clinical center staff, the ratio of the red team has gone too far. in the farmhouse letter dated 16 May from September department heads center and lead investigator Harvey Alter, they wrote that the claim that patient safety has taken a back seat to research is "simply incorrect." they suggested the red team would come to different conclusions if they had met several leaders of clinical research and patients tested positive reviews by accreditation outside agencies, and considered standard measures for the quality of care- such as patient data and falls infections.
instead the red team "deficiencies amalgamated in certain transactions clinical centers" as "an indication of the quality" of care for each patient, said the letter, first described by on Wall Street Journal . The resulting report and subsequent news coverage, they wrote, has "demonized [Clinical Center] leadership, demoralized employees high effective ... and alarmed our patients."
The members of the Advisory Group of the Clinical Center patients weighed, too, noting in an open letter yesterday that they are not aware of any harm to patient safety. They make a plea to keep Gallin and his management team, which they argue have become "scapegoats" for wider problems such as unstable funding the center.
A more measured letter 27 May of a committee of the clinical directors of the NIH institutes also expressed "concerns". the authors emphasize that the center's safety standards are higher than in most hospitals because all patients are part of an approved research protocol and are closely monitored. At the same time, the Committee agrees with some of the problems identified in the report, including the fact that funding for the Clinical Center operations comes from a tax on NIH institutes. The center needs its own flow budget and more money spent to make the necessary changes, the letter suggests.
Another conclusion widely accepted in the Red Team report is that it is a problem that many people working in the Clinical Center report to the leaders of their institutions, and not the center. Collins has already answered that question by giving these employees an additional information line to the director of Clinical Center, NIH said.
The president of the Red Team, former Lockheed Martin CEO Norm Augustine, did not respond to an email request for comment. But team member Harlan Krumholz, a cardiologist at the University of Yale, defended the report's findings, saying it was based on interviews with experts from the NIH, site visits, and reading " extended materials. "
"We saw clear opportunities to raise systems so they can more reliably ensure the safety" of patients, Krumholz said science Insider. Regarding the lack of data showing larger issues report of patient safety, he added, "the question that led to the red team should be enough of a problem of proof."
Today, the NIH issued a "correction" to the assertion of Red team report that the clinical Center does not collect common quality control measures. "in fact, the Centre collects clinical parameters associated with patient safety ", but NIH is evaluating if more are needed, the red team web page states.
Although several signatories of the letter May 16 did not respond to emails asking for comment, a clinical research manager said NIH Science Insider that "hundreds" of staff are upset by the ratio of the red team and the response of Collins, which they fear will "ruin" of the clinical Center. A group called the Assembly NIH scientists representing staff Intramural also planning to write Collins, but held off until after the meeting with him today.
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