April 20, 2016

Statement on NIH Clinical Center Improvement Plan

The Clinical Center on the National Institutes of Health (NIH) campus in Bethesda, Maryland, has made historic contributions to medical research. Many breakthroughs have occurred and many lives have been saved in this largest hospital in the world dedicated to clinical research. But, above all else, the hospital has an obligation to ensure that its processes for patient safety and quality of care are world class. Therefore, it was deeply disturbing to me when I learned last May of serious deficiencies in the hospital Pharmaceutical Development Section identified by the U.S. Food and Drug Administration (FDA). Fortunately, there was no evidence then, and there is no evidence to this date, that any patients were harmed by these problems, but it was incumbent on NIH to act swiftly.

While the immediate deficiencies identified by FDA have since been addressed, it became clear to me while addressing these issues that a broader review of hospital operations was needed by outside experts in hospital management and administration, patient safety, and clinical laboratory quality and safety regulations. I established a working group of my Advisory Committee to the Director (ACD) made up of such experts to evaluate and make recommendations about ways to enhance the overall organization, financing, and management of the Clinical Center and its affiliated labs and production facilities. Today, the ACD has delivered a set of strong recommendations based on the working group’s findings that aim to improve the Clinical Center by fortifying a culture and practice of safety and quality; strengthening leadership for clinical care quality, oversight and compliance; and addressing sterile processing of all injectable products to ensure quality controls are at the highest standards.

I want to personally thank the members of the working group. These renowned leaders in hospital and research administration and management have provided their time, knowledge, and expertise to help develop a plan that will establish and sustain world class standards at the Clinical Center.

In response to these recommendations, I am taking the following immediate actions:

  • Establishing a hospital board and appointing Laura Forese, M.D., as chairperson. Dr. Forese, who is a member of the working group, currently serves as executive vice president and chief operating officer at New York-Presbyterian. The hospital board will be composed primarily of external advisors, replacing the current NIH Advisory Board for Clinical Research. The scope of the new board will be to advise on the Clinical Center’s performance, including management, finances and quality; requirements for hospital leadership and gaps in expertise; and policies and organizational approaches that promote quality and patient safety.
  • Establishing a Clinical Practice Committee of senior clinical and laboratory experts, with a charge to carry out continuous surveillance of all clinical activities in the Center and suggest strategies for improvement.
  • Announcing the selection of Kathryn Zoon, Ph.D., as interim director of the newly established NIH Office of Research Support and Compliance to improve the agency’s ability to maintain the highest levels of compliance with research regulations and standards. Dr. Zoon was previously the scientific director for the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases. From 1992 to 2002, she was the director of the FDA’s Center for Biologics Evaluation and Research (CBER).
  • Making changes to performance plans for clinical staff by adding patient safety elements that are consistent across all NIH Institutes and Centers. This will enhance accountability and ensure that staff is meeting uniform hospital standards for patient care.
  • Hiring Working Buildings and Clinical IQ, two companies specializing in quality assurance for manufacturing and compounding, to conduct assessments of all facilities that produce sterile or infused products for administration to research participants at NIH to ensure compliance with Current Good Manufacturing Practices and other regulations. This work is already well under way.

In addition to these immediate actions, NIH will implement other recommendations provided today by the ACD over the course of this year. Meanwhile, patients who come to the Clinical Center can be confident that they will continue to be cared for by highly dedicated medical professionals. Continuous improvement is an essential part of hospital management, and this is an opportunity to strengthen our patient safety framework. These changes and improvements will help ensure that the Clinical Center will reinforce its commitment to patient safety and compassionate care, while continuing its record of extraordinary scientific accomplishments.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health