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Governance
The Clinical Center’s unique and valuable contribution to the healthcare sector rests in its ability to respond quickly and creatively to ever-changing and growing clinical research needs. Strides in medical technologies, imaging sciences and molecular research require an adaptable, flexible facility and organization for scientific investigation and exploration. The responsive, articulate cooperative interactions of its governing and advisory bodies enable the Clinical Center to better meet and respond to the demands and challenges of the NIH institutes and centers.
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Brianne Schwantes rides in a carriage in the 2003 Cherry Blossom parade representing her home state of Wisconsin as a Cherry Blossom Princess. Schwantes, a senior at American University, has been coming to the Clinical Center for more than 20 years to receive treatment for osteogenesis imperfecta, or brittle bone disease.
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Board of Governors
This 15-member group, established in 1996 by the Health and Human Services Secretary, consults with, and makes recommendations to, the NIH director and the Clinical Center director on issues relating to the operations of the Clinical Center, including budget and strategic and operational planning. The full board meets three times annually and the executive committee meets twice a year. Board membership, appointed by the NIH director, is comprised of physicians, scientists and healthcare managers from across the NIH and the nation’s top academic medical centers.
Board of Scientific Counselors
The purpose of this group is to secure unbiased and objective evaluations of the intramural research programs and work of individual scientists. Expert scientists from outside NIH participate as members of this review group. The Board of Scientific Counselors of the Clinical Center was established in October 1990 and advises the NIH director, NIH deputy director for intramural research and the Clinical Center director on the Clinical Center’s intramural clinical research programs though periodic visits to the laboratories to assess the research of, and evaluate the performance of, the independent investigators.
Accreditation
The Clinical Center adheres to the highest standards in the conduct of its clinical research, delivery of patient care services and clinical research education. This enables the Clinical Center to assure safe, quality patient care and the highest level of clinical research practices. Several organizations guide the overall Center operations through the evaluation and accreditation processes.
Accreditation Council for Graduate Medical Education (ACGME)
ACGME is responsible for the accreditation of graduate medical training programs within the United States. Accreditation is accomplished through a peer review process and is based upon established standards and guidelines. Both individual training programs and the primary institution are reviewed on an approximately five-year cycle by ACGME. The NIH and Clinical Center are institutional sponsors of 16 ACGME-accredited programs. In December, 2002, following an institutional site visit in May 2002, the ACGME awarded NIH and the Clinical Center a favorable review with institutional re-accreditation. NIH was commended for “its commitment to Graduate Medical Education with leadership and resources to achieve substantial compliance with the Institutional Requirements.” During the site visit reviewers met with members of the NIH Graduate Medical Education Committee (GMEC), consisting of the 16 program directors and the acting director of the NIH Office of Education, co-chairs of the GMEC who prepared all of the review documents, and the NIH and Clinical Center leadership. A resurvey will occur in October 2007.
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Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
 JCAHO is an independent, not-for-profit organization that sets the standards by which healthcare quality is measured both nationally and internationally. The Clinical Center was surveyed by JCAHO in 2003 and received 99 out of 100, its highest score ever. The review team was impressed with the quality of care provided to the clinical research patient volunteers and the degree to which the Clinical Center staff are aligned to the mission of the organization. The survey’s purpose is to evaluate the organization’s performance in areas that affect patient care. Beginning in 2006 surveys will be “unannounced” approximately every three years in contrast to “formally” announced reviews as have traditionally been conducted. A year-and-a-half after an “unannounced” visit the Clinical Center must conduct a self-review and forward the results to JCAHO.
A key aspect of the Clinical Center’s Clinical Quality Program is patient safety. Patients are critical partners in the clinical research process. The Clinical Center must assure that its patients are educated about the care they receive and their rights and responsibilities as clinical research volunteers. With input from patients, NIH institute and center colleagues and Clinical Center staff, a brochure published in 2003 stresses the patients’ vital role as the central figure on the healthcare team in assuring safe care. Printed in both English and Spanish, “Speak Up for Your Safety” is given to all new patients upon admission.
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Association for the Accreditation of Human Research Protection Programs (AAHRPP)
AAHRPP works to protect the rights and welfare of research participants by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. In preparation for their accreditation process the AHRPP used the NIH Clinical Center as a pilot site. The evaluation team met with Clinical Center staff, NIH institute representatives and researchers and observed more than a dozen NIH Institutional Review Board sessions. The team was favorably impressed with how the Clinical Center conducts biomedical research. The pilot test served to enhance AAHRPP’s efforts to establish a “gold seal,” and the process necessary to reach that threshold signifying adherence to a rigorous set of human protection standards. A formal AAHRPP review of the Clinical Center is expected in 2005.
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Women instructors in science and math from major universities in Afghanistan were one of many different groups who toured the Clinical Center in 2003 to view how laboratory research is translated into clinical therapies for human disease. The Afghani women were recipients of a Fulbright grant program focusing on enhancing their professional development.
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Clinical Laboratory Improvement Amendments (CLIA)
The Centers for Medicare & Medicaid Services regulate all laboratory testing, except research, performed on humans in the United States through CLIA. The Clinical Center’s Department of Laboratory Medicine was CLIA-accredited in 2002 by the Centers for Medicare & Medicaid Services. This authorizes the department to accept human specimens for the purposes of performing laboratory examinations. CLIA covers approximately 175,000 laboratories. The objective of the CLIA program is to ensure quality laboratory testing.
College of American Pathologists(CAP)
A peer-to-peer inspection is conducted every two years as part of the CAP’s Commission on Laboratory Accreditation. The Clinical Center’s Department of Laboratory Medicine and the NCI-led Department of Anatomical Pathology were accredited “with distinction” by the CAP during its last visit in 2002. During that year the commission added the terms “with distinction” to mark laboratories that passed the rigorous criteria with especially high marks. The Clinical Center’s Department of Laboratory Medicine is one of more than 6,000 nationwide CAP-accredited laboratories. The accreditation program began in the early 1960s and is recognized by the federal government as being equal to, or more stringent than, its own inspection program. The CAP is a medical society serving 15,000 physician members and the laboratory community throughout the world. The Clinical Center’s next CAP inspection will be conducted in 2004.
See more information:
Clinical Center Board of Governors >
Clinical Center Medical Executive Committee >
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