From the Deputy Director for Intramural Research

Making a Great Institution Even Greater: In Pursuit of Perfect

Red Team Report Update

BY MICHAEL GOTTESMAN, DDIR

The NIH Clinical Center is one of the most distinctive and influential research hospitals in the world. Many of its patients have rare and difficult-to-treat conditions, and the Clinical Center—with its numerous first-in-human studies, a dedicated staff of unique talent, and a backbone of hundreds of NIH principal investigators conducting research in surrounding NIH institutes and centers (ICs)—is often the last hope for these patients. Despite often insurmountable odds, this extraordinary staff seeks to cure patients, extend lives, and reduce suffering. Indeed, in 2011, the Clinical Center won the prestigious Lasker-Bloomberg Public Service Award. Bricks and steel and pretty sunlit atriums don’t win such awards. People do. And the Lasker-Bloomberg award went to the entire Clinical Center staff.

Making Something Great Even Greater

The challenge before us now is how to make something great even greater. Recently, the “Red Team” (a working group of the Advisory Committee to the Director, ACD) was asked to review multiple aspects of the Clinical Center. The sentinel event that led to the need for this review occurred in May 2015 when the FDA identified significant deficiencies in the Clinical Center pharmacy, leading to the closure of the Pharmaceutical Development Section. An internal review then revealed several other areas of concern in the Clinical Center. The Red Team was established to obtain expert outside advice about possible remedies. In the course of its four-month-long review, the Red Team raised questions about whether the distributed organizational structure of the Clinical Center, and the absence of certain fail-safe systems and appropriate oversight, could lead to risks to patient safety and quality of care.

New Clinical Center Research Hospital Board

One of the Red Team’s major recommendations was to establish a new Clinical Center Research Hospital Board. That group met for the first time on Friday, July 15, 2016, in an open meeting. All NIHers were invited to attend in person or listen in on the presentations and discussions that dealt with how to improve systems that improve patient safety and governance of the Clinical Center (https://videocast.nih.gov/launch.asp?19791).

The board, chaired by Laura Forese, a pediatric orthopedist and chief operating officer of the New York–Presbyterian hospital system, was introduced to the Clinical Center by NIH Director Francis Collins, who described the current structure of the Clinical Center and some of its many contributions to modern medicine. Dr. Collins related that the press coverage of the Red Team report had delivered a significant blow to staff morale because it seemed to imply that the quality of patient care is routinely compromised at the Clinical Center, which is simply incorrect. He stated unequivocally that the vast majority of physicians, nurses, and other staff who work at the Clinical Center are highly capable and compassionate health-care providers, deeply dedicated to patient care.

In addition, Dr. Forese indicated that every member of the Red Team made it clear that they would not hesitate to be a patient in the Clinical Center themselves. And in a remarkable series of testimonials, each of the members of the new Hospital Board (including two representatives of the Patient Care Advisory Group) reiterated their confidence in the dedication of the Clinical Center staff.

One of the new board members is Paul O’Neill, former Alcoa CEO and United States Secretary of the Treasury, who has dedicated much of his career to improving employee safety and more recently to patient-safety issues. He was eloquent in his description of the importance of engaging the entire community in efforts to improve safety for both patients and employees, noting that health-care workers have the highest incidence of on-the-job injuries of any U.S. industry. Laura Lee, director of Patient Safety in the Clinical Center, noted that for standard metrics, the Clinical Center has a strong track record of patient safety—but the goal, as articulated by Mr. O’Neill, is “the pursuit of perfect.”

Changes

In reaching for this goal, the Red Team identified some aspects of the Clinical Center that needed work. John Gallin, director of the NIH Clinical Center, Avindra Nath, chair of the Medical Executive Committee, and Henry Masur, representing the chairs of the Clinical Center departments, presented constructive ideas for how to make needed improvements. Many of the changes that have to be made will need to originate from the professional and support staff at the Clinical Center, especially those who have direct and intensive patient-care responsibilities.

Steven Holland has already moderated a series of six open meetings with staff at all levels in the Clinical Center, and these meetings have given NIH leadership an opportunity to hear directly about the concerns and ideas of our colleagues. Additional meetings and focus groups are being planned to get into more detail about changes that can be made.

Dr. Collins and NIH Principal Deputy Director Lawrence Tabak summarized some of the changes that have already taken place to date including:

• New Office of Research Support and Compliance (ORSC): Establishment of a new ORSC in the Office of Intramural Research, under the supervision of the Deputy Director for Intramural Research. Kathryn Zoon, former scientific director of NIAID, ably served as inaugural acting director of ORSC for the first couple of months but retired on June 23. Andrew Griffith has generously agreed to become acting Deputy Director for Intramural Clinical Research and will be the formal leader of ORSC while a national search is underway. To assist Dr. Griffith, Valerie Bonham, previously legal counsel with NIH’s Office of General Counsel, has stepped in as Deputy Director of ORSC and will provide regulatory knowledge and management skill. Furthermore, Bruce Burnett, an experienced manager of Current Good Manufacturing Practice facilities and clinical activities at Duke University School of Medicine (Durham, North Carolina), will be a major contributor to the leadership of this office. (He arrived at NIH on July 18). He will begin by meeting our clinical directors and scientific directors and acquainting himself with current practices while we devise better support mechanisms for clinical research in all of our ICs. If you hear from any of these people, trust that they are here to help our clinical programs function with the highest possible safety and efficiency.
• Search for chief executive officer: A search committee has been established and an advertisement has been placed for a new chief executive officer to manage the operations of the Clinical Center. Discussion of the characteristics of a new Clinical Center CEO emphasized hospital-management skills, because it is expected that there will also be a chief scientific officer responsible for the clinical research conducted by the Clinical Center staff and the principal investigators in the ICs.
• Governance structure: One model for a possible new governance structure for the Clinical Center was proposed by Dr. Tabak. He stressed that this model was only a starting point for discussion, and he hopes and expects there to be modifications with input from all of the stakeholders across and outside NIH. Although the details of this structure are therefore not yet established (many decisions must await the arrival of a new CEO), some features have been endorsed by the IC directors, including the direct reporting of all clinical directors to their IC directors. This reporting relationship will establish that each IC director is providing oversight for quality of patient care and clinical research. The Red Team also strongly advocated for the formation of a Clinical Practice Committee consisting of clinical experts at different levels and in different areas of patient care, to establish the highest possible standards of practice in the Clinical Center. The precise makeup, scope of responsibility, reporting arrangements, and interactions with the Medical Executive Committee will be important areas for future discussions with staff and among leadership.

Helping the Clinical Center address the Red Team’s recommendations will be one of the most important tasks of my tenure as Deputy Director for Intramural Research, and we are only beginning this process. The Clinical Center lies at the physical and emotional heart of the NIH Bethesda campus. We intend to keep it there, for no living and dynamic entity can survive without its heart.

For further reading (and viewing), see Michael Gottesman’s editorial in the May–June 2016 issue of the NIH Catalyst and the presentation that he and Clinical Center Director John Gallin made at the April 22 town hall meeting (NIH only, at http://videocast.nih.gov/launch.asp?19639). The NIH response to the Red Team’s report was approved by the ACD on June 9. Download the response (http://acd.od.nih.gov/Red_Team_final_report_4262016.pdf) and slides from the ACD presentation (http://acd.od.nih.gov/presentations/062016_RedTeam.pdf).