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NIH hospital needs sweeping changes, panel says

🕐 2 min read

Practices at the National Institutes of Health Clinical Center, the hospital where cutting-edge medical research is conducted, require sweeping reform to better protect patient safety, a task force appointed by the agency reported Thursday.

The panel of experts, appointed by NIH Director Francis S. Collins, found that the hospital’s research focus sometimes took priority over the safety of the critically ill patients treated there. It also said that the center has many “outdated or inadequate facilities” and that personnel lack expertise on regulations that apply to the hospital and its research and drug-manufacturing units.

The task force concluded that while clinical research at the hospital is integral to its mission, “it suffers from shortcomings that potentially impact patient safety and research outcomes.” Regulatory deficiencies in its drug-production components “are examples of sustained weaknesses in structure, facilities, practices and compliance.”

Throughout the center, “patient safety was occasionally put at risk, perhaps as a result of a well-intended, single-minded focus on research with an unintended but concerning concommitant inattention to safety,” the task force wrote in its report.

There is no evidence that anyone was harmed, Collins said in a statement responding to the report. But he immediately announced that he was appointing an outside board to advise him and NIH about the hospital’s performance, management, finances and quality, its leadership needs and ways to promote patient safety.

The board will be headed by Laura Forese, chief operating officer of New York-Presbyterian, a health-care organization that includes six hospitals in the New York City area.

Collins also said he would hire two outside consulting firms to review all hospital facilities that make “sterile or infused products” given to patients who participate in NIH research.

The review was launched last year after NIH was forced to suspend the operation of a unit that manufactured drugs for clinical research when two vials of a product were found to be contaminated by fungus. The contamination was discovered after a complaint to the Food and Drug Administration, and its subsequent inspection in May found a series of problems.

The FDA identified defects in the drug unit’s air-handling system, deficient systems to clean and disinfect equipment, and a lack of compliance with standard operating procedures. Those included insects in two ceiling lights in clean rooms.

Just this week, NIH suspended production at two laboratory-manufacturing facilities at its Bethesda, Maryland, campus after an internal inquiry determined they were not in compliance with safety standards and posed potential risks to patients. One of the labs was at the National Cancer Institute and the other at the National Institute of Mental Health.

That NCI lab is headed by prominent oncologist Steven Rosenberg, known for his longtime work on immunotherapy. The NIMH lab manufactures molecules used in brain imaging, according to the journal Nature.

NIH officials said there was no indication that patients were harmed as a result of those labs’ problems.

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