The National Institutes of Health Clinical Center is the largest hospital in the nation devoted entirely to clinical research. There are currently an estimated 1,600 ongoing clinical research studies at the NIH Clinical Center, including studies on the natural history of disease, especially regarding rare diseases and clinical trials. However, a new report on NIH reveals patient safety issues, including poor management and communication, lack of accountability, and outdated equipment.
These findings surfaced after an initial report produced in 2016 by an NIH-appointed task force. The inspection was prompted by a complaint to the Food and Drug Administration that uncovered a fungus contaminant in two vials of a product produced for clinical research. Operation of that unit was suspended and the report stated that the hospital needed sweeping reform to address patient safety issues.
The task force found that NIH had outdated or inadequate facilities, that personnel lacked necessary expertise on relevant regulations, and the hospital’s focus on research took priority over patient safety. NIH’s regulatory deficiencies in drug production and other shortcomings could potentially impact patient safety and research outcomes. A subsequent inspection by the FDA revealed defects in the drug unit’s air handling system, lack of compliance with standard operating procedures, and inadequate cleaning and disinfecting systems for equipment.
The NIH director announced that he would be hiring a board of experts to give advice on several issues, including the hospital’s performance and ways to promote patient safety. A new management team was hired with the goals of improving oversight and patient safety. Also hired was a former U.S. Health and Human Services official to lead focus group discussions about how to improve NIH and produced a report based on interviews of NIH participants over the course of four months.
However, the new report found that NIH still has patient safety concerns and that many staff members suffer from low morale because of the previous year’s report. The latest report also highlights the outdated equipment for which parts cannot be found, the 45-minute emergency transfers to other hospitals, and the difficulty of identifying the responsible physician due to the fact that patients often take part in different research protocols.
NIH reports that despite these shortcomings, the facility is a great research hospital and that it is a place in which the frontiers of biomedical knowledge are advanced every day. NIH officials are addressing some of the recommendations to improve communications and conduct facility repairs. The former HHS official stated that the process afforded him a better understanding of the problems facing the hospital and he looks forward to seeing what can be achieved once the problems are corrected.
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