National Institutes of Health Clinical Center

Warren G. Magnuson Clinical Center Mark O. Hatfield Clinical Research Center

Theres no other hospital like it!

2010 Strategic and Annual Operating Plan

Message from the Clinical Center Director

A long-time Clinical Center patient welcomed President Barack Obama to the Clinical Center when he made his first visit to NIH on September 30, 2009. It was a fitting introduction to the work conducted here. President Obama said in his remarks to those gathered in Masur Auditorium, The work you do is not easy. It takes a great deal of patience and persistence. But it holds incredible promise for the health of our people and the future of our nation and our world. The Clinical Center is an extraordinary resource for the NIH intramural clinical research program. Productive collaboration and planning with our Institute partners and provision of the best quality care for our patients continues to drive our mission. In 2009, we saw over 10,000 new patients and Institute clinical research activity is sustaining healthy increases. However, our work is not without challenges. We continue to operate with tight budgets which forces us to make difficult decisions. Our funding model and governance structure are under examination by a Congressionally-appointed review board. Because of our stellar workforce and patient-partners committed to helping further medical discovery, the Clinical Center is up to these challenges. The strategic part of this plan articulates our mission and vision as the nations clinical research hospital. The operations portion details the annual performance targets that have grown out of ongoing discussions with Institute and Center investigators, key stakeholders, and patients. The goals in this plan represent work necessary to fulfill our mission, and ultimately, support the promise for better health and health care for all. 2010 promises to be a year of remarkable scientific opportunity and our mandate is an unyielding commitment to excellent clinical research, patient care, and education in support of translational investigation.

John I. Gallin, M.D. Director, NIH Clinical Center

Strategic and Annual Operating Plan Framework

Vision Vision
Environmental Influences/ Input from Key Partners

Mission Mission

Core Core Processes Processes

Strategic Operational

Annual Annual Performance Performance Assessment Assessment

Organizational Performance Cycle

Strategic Strategic Goals Goals

Annual Annual Targets Targets

Vision Statement

As Americas research hospital, we will lead the global effort in training todays investigators and discovering tomorrows cures.

A A vision vision statement statement answers answers the the question: question: "What "What do do we we strive strive to to be? be? and and is is a a shared shared view view that that defines defines what what the the organization organization wants wants to to do do or or become. become.

Mission Statement

To provide a versatile clinical research environment enabling the NIH mission to improve human health by: investigating the pathogenesis and natural history of disease; developing state-of-the-art diagnostic, preventive and therapeutic interventions; training the next generation of clinical researchers; and ensuring that clinical research is safe, efficient, and ethical.

A A mission mission statement statement answers answers the the question: question: What What is is our our fundamental fundamental purpose? purpose?

Clinical Center Core Processes

Clinical Research and Education Provide staff, services, training, and the environment to support clinical research. Patient Care Provide outstanding patient care to participants in clinical research studies. Operational Management Provide resources such as personnel, budget, and capital equipment in the most cost-effective and efficient manner.

Core Core processes processes are are the the major major activities activities that that support support the the mission. mission.

Clinical Center Strategic Goals

Continually improve the clinical research and training environment for the Intramural Research Program and serve as a national and international resource. Develop and promote best practices for safe and effective care of patients participating in clinical research. Deploy resources strategically and efficiently to optimize clinical research programs.
Strategic Strategic goals goals translate translate the the vision, vision, mission, mission, and and core core processes processes into into performance-based performance-based action action plans. plans.

Network of Environmental Influences*

Environmental Environmental influences influences are are drivers/barriers drivers/barriers considered considered in in strategy strategy development. development. Key Key partners partners are are customers/stakeholders customers/stakeholders whose whose input input and and requirements requirements inform inform our our strategic strategic direction. direction.
*For full text version of environmental influences, see National Institutes of Health Clinical Center, 2009 Environmental Assessment, a companion document to the Clinical Center Strategic and Annual Operating Plan.

2010 Key Strategic Challenges

The interdependent challenges outlined below are not new but perhaps are more prominent in the current climate of ongoing budget constraints. The Scientific Management Review Board (SMRB)*, a Congressionally-appointed group, is currently studying the intramural program with the goal of recommending sustainable solutions for a vibrant clinical research program. Optimizing Capacity and Utilization Striking the right balance between optimal use of the Clinical Center and the NIHs ability to fund investment in intramural clinical research is an ongoing challenge. In recent years, the CC has been underutilized, straining NIHs ability to generate an optimal level of clinical research. This underutilization prompted concerns related to high unit costs and the potential unrecognized opportunity for use of the unique resources of the CC. However, over the past year, the CC has witnessed sustained growth. Fueled by increases in the areas of Hematology/Oncology Transplant and Adult Oncology, 122 new protocols were implemented resulting in an increase in the average daily census (ADC) of 14 patients per day with a simultaneous increase in severity of illness. Additionally, the number of tenure track principal investigators writing protocols increased by 26 percent. This growth is encouraging because it signals a commitment to clinical research and the presence of a large and stable number of patients helps clinicians to maintain clinical skills and competencies. This activity level also provides enough patients to enhance the value of the investment and reduce unit costs. The new activity, however, comes at a price. With the CC budget unable to keep up with the unprecedented growth in activity, the NIH has had to make unpopular resource allocation decisions. Costs of selected research services which have been supported historically by the CC have been shifted to the Institutes, resulting in some unintended negative consequences in investigators ability to carry out certain studies. Limited Resource Streams/Budget The CC is subject to the strains of annual healthcare inflation but does not have a traditional revenue stream to offset costs. It is funded at the beginning of each fiscal year by a tax on NIH intramural programs**. Thus, unlike other hospitals, admitting more patients to the CC results in added cost but not added revenue. The CC can only impact resource availability through cost containment efforts. Although the possibility of third party collection has been analyzed in-depth on multiple occasions, the decision to initiate third party collection has been deferred due to the expense of a billing infrastructure that outweighs the possible revenues collected. NIH intramural leaders felt that the risk of compromising the clinical research mission by charging patient volunteers for standard of care services, and burdening principal investigators with additional paperwork in an environment already laden with bureaucratic and regulatory compliance activities, was not worth the uncertain potential financial gain. *For additional details, see Scientific Management Review Board, p. 25 **For additional details, see Budgetary Constraints, p. 22

2010 Key Strategic Challenges

Programmatic Planning and Governance Many have argued that if the NIH developed an overarching plan for clinical research, then planned Institute activity could be balanced with available resources. However, under the current planning and governance process, stovepiped demands have resulted in sustained activity increases with underfunded support. The Scientific Management Review Board is deliberating on solutions which are responsive to trends in science, capitalize on the unique resources of the Clinical Center, incentivize collaboration across Institutes and between intramural and outside investigators, and foster governance decisions that are based on agreed-upon overriding principles.

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Identifying the Annual Targets

Despite the ongoing strategic challenges, maintaining a strong infrastructure for clinical research is a critical ongoing imperative for the Clinical Center. In this regard, the Clinical Center must balance the needs of the 17 Institutes whose research programs are carried out in the Clinical Center; continuously improve its services and capital infrastructure in support of the highest quality clinical research and excellent patient care; and meet both these mandates with a cautious consideration of the need for efficient use of resources. While the SMRB and NIH are strategizing on how to fix the key challenges of optimal utilization, funding, governance and planning for the NIH intramural clinical research program, this plan identifies ways to improve the environment for patient care and clinical research support (issues which are in the purview of the Clinical Centers mission). The targets being pursued are the result of discussions with Institute leaders, clinical investigators, patients, and staff. Additionally, the Clinical Center considers trends in its environment such as healthcare issues, technology growth, and goals of the Administration in selecting its targets. Further details of the input provided by these stakeholders are found on pages 17-34 of this plan and in the CC Environmental Assessment.* *For full text version of environmental influences, see National Institutes of Health Clinical Center, 2009 Environmental Assessment, a companion document to the Clinical Center Strategic and Annual Operating Plan.

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Annual Targets
Each of the 11 annual targets identified below is assigned to a member of the Clinical Center executive team who provides leadership and oversight to the development of a project plan for each target. Each project plan includes a definition of the scope of the initiative, a statement of outcomes expected to be achieved, and a timeline with milestones identified. All projects are monitored on a quarterly basis by presentations to the Clinical Center Executive Committee and other key stakeholders. An end-of-year evaluation is developed which summarizes progress toward goals, adapting the green, yellow, red light reporting approach in use by the federal Office of Management and Budget.
Core Processes

Clinical Research and Education

Continually improve the clinical research and training environment for the Intramural Research Program and serve as a national and international resource. 1. Implement a mechanism for the provision of mutational analysis. 2. Pilot sabbatical program in clinical research management.* 3. Pursue additional international clinical research training sites.* 4. Complete and disseminate tools to support the subspecialty of clinical research nursing.*

Patient Care
Develop and promote best practices for safe and effective care of patients participating in clinical research.

Operational Management
Deploy resources strategically and efficiently to optimize clinical research programs.

Strategic Goals

1. Implement bedside bar-coding for blood products and design a bar-coding process for medication administration. 2. Implement new processes to improve communication with referring physicians. 3. Develop fully integrated, interdisciplinary edocumentation for ICU. 4. Expand point-of-care testing in Radiology for enhanced safety and efficiency.

1. Implement an outpatient pharmacy system and develop a process to track costs. 2. Implement strategies to reduce inpatient length of stay. 3. Establish an IT Advisory Group to evaluate and coordinate recommendations on priorities for clinical and administrative technological solutions and ensure risks are effectively mitigated.

2010 Annual Targets

* These annual targets support the strategic goal of CC as a national and international resource.

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Financial Assessment of Annual Targets

Clinical Research and Education Annual Target Financial Impact for FY 2010

1. Implement a mechanism for the provision of mutational analysis.

CC to develop infrastructure. ICs to pay costs for 2010; out-year funding model to be developed.

2. Pilot sabbatical program in clinical research management.

Housing costs of $40K/year will be outlaid by CC with recovery of costs expected. Other costs include existing staff time by CC contributors.

3. Pursue additional international clinical research training sites.

Budget neutral.

4. Complete and disseminate tools to support the subspecialty of clinical research nursing.

Budget neutral.

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Financial Assessment of Annual Targets

Patient Care Annual Target Financial Impact for FY 2010

1. Implement bedside barcoding for blood products and design a bar-coding process for medication administration.

$2.4M in equipment funded by the American Recovery and Reinvestment Act (ARRA). CC FY 2010 budget includes funding balance of $1.1M for software.

2.

Implement new processes to improve communication with referring physicians.

Software purchased in prior fiscal year. No added costs for implementation of processes.

3. Develop fully integrated, interdisciplinary edocumentation for ICU.

CC FY 2010 budget includes an allocation of $250K for additional nursing time needed to develop process. $40K for software development.

4.

Expand point-ofcare testing in Radiology for enhanced safety and efficiency.

CC budget for FY 2010 includes $40K to fund this project.

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Financial Assessment of Annual Targets

Operational Management Annual Target Financial Impact for FY 2010

1. Implement an outpatient pharmacy system and develop a process to track costs.

$1.1M in ARRA funds for software, hardware and services.

2. Implement strategies to reduce inpatient length of stay.

Budget neutral. Intention is to save resources.

3. Establish an IT Advisory Group to evaluate and coordinate recommendations on priorities for clinical and administrative technological solutions and ensure risks are effectively mitigated.

Budget neutral.

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Clinical Center Planning/Budget Review Process

September/ October
Programmatic Requirements

Institute Institute Planning Planning Meetings Meetings

CC CC Develops Develops Themes Themes

November/ December

CC CC Prepares Prepares Budget Budget & & Operating Operating Plan Plan

February/ March

NIH NIH Advisory Advisory Board Board for for Clinical Clinical Research Research

April/May

Intramural Intramural Working Working Group Group

June/July
Reviews

Management Management and and Budget Budget Working Working Group Group

September

NIH NIH Steering Steering Committee Committee

IC IC Directors Directors

NIH NIH Director Director

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2010 Government Initiatives

The Clinical Center, in developing the priorities for its strategic and annual operating plan, seeks input not only from Institute investigators and the patients they admit, but also looks beyond its immediate environment to understand the broader goals of the federal government. The highest level goals which have influenced managerial objectives have come from the four federal initiatives described below. The President's Management Agenda (PMA), announced in the summer of 2001, is an aggressive strategy for improving the management of the federal government. Under President Obamas leadership, the PMA focuses on six overarching themes aimed at building a high-performing government: Putting Reform First: A New Performance Improvement and Analysis Framework Ensuring Responsible Spending of Recovery Act Funds Transforming the Federal Workforce Managing Across Sectors Reforming Federal Contracting and Acquisition Transparency, Technology, and Participatory Democracy The Government Performance and Results Act (GPRA), enacted in 1993, requires federal agencies to establish standards for measuring their performance and effectiveness. The law requires federal agencies to develop strategic plans describing their overall goals and objectives; prepare annual performance plans containing quantifiable measures of their progress; and present performance reports describing their success in meeting those standards and measures. The Program Assessment Rating Tool (PART) is the quality control assessment tool overseen by the Office of Management and Budget (OMB) that is used to evaluate the fulfillment of the PMA and implementation of GPRA on a program-specific basis. Under the Obama Administration PART will be replaced with a New Performance Improvement and Analysis Framework which will require agency leaders to identify priority goals, demonstrate progress and explain trends. Working with agency leaders and the Performance Improvement Council, the Administration will streamline reporting requirements to reduce the burden on agencies and OMB. The American Recovery and Reinvestment Act (ARRA) of 2009. A direct response to the economic crisis, the Recovery Act has three immediate goals: Create new jobs as well as save existing ones Spur economic activity and invest in long-term economic growth Foster unprecedented levels of accountability and transparency in government spending Through the Recovery Act, the Department of Health and Human Services received $55.63B to fund scientific research and promote infrastructure development and enhancement. While goals may evolve as new initiatives are implemented, the Clinical Center will continue to stand ready to respond quickly and with flexibility.

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Health Care Industry Trends

Patient Patient Safety Safety and and Clinical Clinical Quality Quality
The safe and effective care of patients who come to the Clinical Center as participants in clinical research protocols is an essential aspect of the Clinical Center's mission. The landmark Institute of Medicine report, "To Err is Human: Building A Safer Health System,* and their follow-up report, Crossing the Quality Chasm: A New Health System for the 21st Century,** called on health care organizations worldwide to take an active and aggressive approach to identify, understand and mitigate risk associated with the processes of medical care. The inherent risks associated with clinical research make this call to action of even greater relevance to the Clinical Center. Clinical Center staff and investigators continually review the patient environment using the Clinical Center Occurrence Reporting System, Failure Mode and Effects Analysis, and Root Cause Analyses, and proactively identify risks associated with clinical care and clinical research. Once identified, strategies to reduce or lessen risk are devised and implemented.

Pharmaceutical/Supply Pharmaceutical/Supply Inflation Inflation

The Clinical Center budget is impacted each year by the rising costs of drugs and medical supplies. Approximately one out of every $10 spent in the Clinical Center goes toward drug purchases. Although the Clinical Center belongs to a drug purchasing consortium, drug inflation (including the replacement of older, less expensive drugs with newer, expensive agents) increases by 5 to 8 percent per year. In an era of flat budgets, these costs must be alleviated by diligent efforts to offset this growth. The Clinical Center continues collaborating with Institutes as they negotiate with pharmaceutical manufacturers to reduce Clinical Center costs for marketed drugs that are being studied for non-approved indications. Through these negotiations, the Clinical Center anticipates potential net savings of up to $4M. The Clinical Center also is evaluating potential savings from no longer dispensing non-protocol related drugs to outpatients (i.e., drugs supporting patient care independent from, but necessary to support, the clinical research process) when the patient has health care insurance that will cover the expense. Inflation of medical supplies, although at a slower rate of approximately 4 to 6 percent annually, also requires cost containment efforts.

Clinical Clinical Research Research Awareness Awareness

Successful clinical research depends on a diverse cadre of volunteers to participate in the investigations as patients and as healthy volunteers. The publics perception and understanding of the safety, risks, and benefits of clinical research affects NIHs ability to recruit volunteers into protocols and retain volunteers in ongoing studies. Public awareness of the issues surrounding clinical research will benefit the clinical research enterprise and recruitment/retention efforts on behalf of the Clinical Center.
*Kohn, L., Corrigan, J., Donaldson, M., Institute of Medicine: Committee on Quality of Health Care in America: To Err is Human: Building a Safer Health System. The National Academy Press, 2000. ** Institute of Medicine: Committee on Quality of Health Care in America: Crossing the Quality Chasm: A New Health System for the 21st Century. The National Academy Press, 2001.

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Health Care Industry Trends

Information Information Technology Technology Development Development
Health care information technology continues to advance at a rapid pace by offering ever-improving technologies to support clinical research and patient care. The Clinical Center is committed to investing in these improvements and system enhancements to support cutting-edge research and the highest quality of patient care. Specifically, the Clinical Center is investigating new methodologies to share and communicate critical information including the use of patient portals, secure messaging between physicians, and mobile technologies. In addition, the health care industry has developed several new system enhancements to reduce medical errors and improve patient safety. The Clinical Center is implementing such technologies, including bar-coding applications for laboratory, blood product transfusion and medication administration processes, medication distribution systems, and integration of automated solutions for Anesthesia, PACU and ICU. The Clinical Center also is working to develop the Biomedical Translational Research Information System (BTRIS), which will bring Clinical Research Information System (CRIS) and Institute/Center data together in a single repository. The repository supports NIH researchers by allowing the efficient use and reuse of data collected in clinical trials. To date, BTRIS includes laboratory and other ancillary system data, data generated in the Clinical Research Information System (CRIS) (e.g., nursing documentation and pharmacy data), archived Clinical Center data from the Medical Information System (MIS), and data from NIAID's Clinical Research Information System (CRIMSON) and from the NIAAA. In FY 2010, the Clinical Center will expand BTRIS to include additional data from the Clinical Center and from NCI systems.

Nursing Nursing Shortage Shortage

The Maryland Hospital Associations annual survey revealed that the state of Maryland continues to experience a nursing vacancy rate of 10 percent, which is 2 percent higher than the nation as a whole. The U.S. nursing shortage is projected to grow to 260,000 registered nurses by 2025. A rapidly aging workforce is cited as the primary contributor to the projected shortage. However, the current state of the national economy has resulted in a temporary lessening of the nursing shortage in some parts of the country due to retired nurses going back into the workforce, those planning on retiring delaying their retirement plans, and nurses who were working part-time changing to full-time status. This situation supported the Clinical Centers effort to rapidly hire nurses to support additional patient activity in the high intensity areas of hematology and oncology.

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Biomedical Science Trends

Molecular Molecular Medicine Medicine
Molecular medicine represents the logical extension of scientific inquiry into human physiology and pathophysiology. Increasingly, NIH Intramural Research Program (IRP) scientists are using molecular approaches that employ a variety of physical, chemical, biological and medical techniques: 1) to identify genus and species and possible clonality of microorganisms; 2) to describe molecular structures and molecular mechanisms; 3) to identify molecular and genetic errors associated with disease states; and 4) to develop tailored molecular interventions to correct them. Beginning with the development of the radioimmunoassay and encompassing the tools of genomics, proteomics, microbiomics and pharmacogenomics, a variety of new techniques have been developed over the past four decades that effectively have created the discipline of molecular medicine.

Genomics Genomics
Genomics is the study of the genetic material of organisms and includes determining the complete DNA sequence of organisms as well as the creation of gene maps and the study of interactions that occur among genes. Techniques have been developed over the past two decades to make the field of genomics possible, including techniques for DNA sequencing, gene- and genome-mapping, data storage, and analysis of the huge data sets produced by these studies. Studies regularly analyze which genes are actively expressed and which are down-regulated in specific disease states. NIH scientists played a significant role in the sequencing of the entire human genome.

Proteomics Proteomics
Proteomics is the large-scale study of proteins and their structure and function. The proteome is the entire complement of proteins produced by an organism, including the modifications made to a particular set of proteins. These modifications occur in response to stress, physiological changes, and other stimuli and contribute to the physiological metabolic pathways within cells. These proteins and modified proteins can be detected and measured in maps using mass spectroscopy and other sensitive techniques. NIH scientists are using proteomics to evaluate host-parasite interaction, normal and abnormal physiology, the bodys response to infection, sepsis, malignancy and in a variety of other settings. Evaluating how proteins are modified in these settings provides insight into molecular physiology and sheds light on possible interventions.

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Biomedical Science Trends

Microbiomics Microbiomics
Microbiomics is the study of the complete set of genetic material (i.e., all the genomic material) from all of the microorganisms in a specific environment (e.g., the gut or the skin). This burgeoning field uses molecular tools to evaluate the microbial diversity in specific environments and determine how changes in the microbiota in these environments contribute to health and disease. Many NIH scientists are aggressively using these molecular techniques to assess the impact of the microbiota of specific human environments (e.g., oral cavity, colon, skin, etc.) on health and in specific disease states.

Pharmacogenomics Pharmacogenomics
Pharmacogenomics is the evaluation of the impact of genetic variation on patients responses to the administration of pharmacologic agents, by attempting to correlate gene expression or single nucleotide polymorphisms with either efficacy or toxicity of the agent. The pharmacogenomic approach provides the practitioner with an opportunity to select the most appropriate agent for a specific patient based on the patients genotype, thereby minimizing adverse drug effects. NIH investigators are using these approaches to tailor cancer chemotherapy strategies for individual patients.

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DHHS/NIH Drivers
NIH NIH Roadmap Roadmap
The NIH Roadmap was introduced in 2003 under the leadership of NIH Director Elias A. Zerhouni, M.D. This Roadmap provides a framework of the priorities that NIH as a whole must address in order to optimize its entire research portfolio. It lays out a vision for a more efficient and productive system of medical research. There are three primary areas of focus: new pathways to discovery; research teams of the future; and re-engineering the clinical research enterprise. The NIH Director convened a blue ribbon panel to make recommendations to align the future direction of the intramural clinical research program with the larger clinical research enterprise re-engineering plan. A key recommendation was the creation of a single governing body to provide oversight for the intramural clinical research program, and the Advisory Board for Clinical Research (ABCR) was the result.

Budgetary Budgetary Constraints Constraints

The Congressionally-appropriated NIH annual budget (approximately $30.5B for FY 2009) has remained relatively constant since FY 2004, increasing a total of 10 percent during this period. Consequently NIH Central Services, including the Clinical Center, have been required to remain relatively constant as well. In FY 2009, the Clinical Center received a 3 percent budget increase (for a total of $362.3 million) to support much needed capital replacement items. Even with the FY 2009 increase, the total Clinical Center budget growth from FY 2004 to FY 2009 was 7.2 percent, mirroring NIH as a whole. The Clinical Center has worked aggressively to become more cost effective in order to support patient census and Institute research program requirements while meeting mandated cost-of-living inflationary increases and pressures associated with health care expenses, including pharmaceuticals and medical supplies. To date, the Clinical Center has been successful in maintaining service levels through careful management of workforce resources and other cost-saving measures. The Clinical Center is engaging with the leadership of the NIH, the Scientific Management Review Board (a Congressionally-appointed group ), and the intramural community, to identify a sustainable funding model. While the Clinical Center budget for FY 2010 will be increased by 3.3 percent to $374.3 million, this is still less than inflationary pressures for the bulk of its cost structure. It is unlikely that the Clinical Center will be successful in meeting a flat budget requirement in FY 2011 without the reduction or elimination of services. The Clinical Centers cost containment focus for FY 2010 will be on implementing strategies and controls in dispensing pharmaceuticals for off-label and/or non-protocol use. The Clinical Center remains strongly committed to maintaining a vigorous clinical research infrastructure even within the confines of extremely limited resources.

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Advisory & Review Groups

NIH NIH Advisory Advisory Board Board for for Clinical Clinical Research Research
The NIH Advisory Board for Clinical Research (ABCR) is charged with providing guidance to integrate the vision, planning, and operations of the intramural clinical research programs of the NIH. The Board advises, consults with, and makes recommendations to the NIH Director and other key leaders. Composed of nine extramural scientists and experts in health care administration and eight NIH intramural scientists, the Board guides in the development of trans-NIH strategic planning and advises on the budget and operating plan of the Clinical Center. A major focus in 2009 has been redefining the role of the Clinical Center in the Intramural Research Program while expanding collaboration across extramural and intramural researchers in an effort to improve access for extramural partners to Clinical Center resources.

NIH NIH Steering Steering Committee Committee

The NIH Steering Committee was established in 2003 by NIH Director Elias A. Zerhouni, M.D., to provide a consistent strategic direction and streamline the decision making processes at NIH. Specifically, the Committee oversees all corporate functions, resources, and policies other than the setting of corporate scientific direction and priorities, in addition to bringing issues of the highest significance to all IC Directors. Membership consists of ten directors derived from and representing the 27 NIH Institutes and Centers who serve on a rotating basis, and the Committee is chaired by the NIH Director, Francis Collins, M.D., Ph.D. A review of the NIH Governance structure currently is in progress under the direction of Dr. Collins.

Intramural Intramural Working Working Group Group

The Intramural Working Group (IWG) is charged with the oversight of activities of the NIH Intramural Research Programs (IRP). This includes the conduct of laboratorybased and clinical research (in the Clinical Center and elsewhere) and research training. The IWG reviews issues and recommends policies of trans-NIH importance that require decisions by corporate NIH, including the IC Directors and the NIH Director, but is not involved in the day-to-day operations of the intramural program.

Management Management and and Budget Budget Working Working Group Group
The Management and Budget Working Group (MBWG) was established by the NIH Director as an advisory group to the NIH Steering Committee, to facilitate decision making on corporate management and resource issues including human resources. The Working Group provides recommendations to the NIH Steering Committee on funding levels for the Clinical Center and other NIH components that do not have separate appropriations.

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Advisory & Review Groups

Intramural Intramural Clinical Clinical Research Research Steering Steering Committee Committee
The NIH Intramural Clinical Research Steering Committee (ICRSC) was established by the NIH Deputy Director for Intramural Research as a forum for trans-NIH governance and policy development in the area of human subjects research. The ICRSC interacts with the Intramural Working Group, Board of Scientific Directors, the Medical Executive Committee, the Human Subjects Research Advisory Committee, and the Advisory Board for Clinical Research as needed to develop and implement plans to improve the environment for clinical research at the NIH, and to coordinate efforts and ensure clear communications about goals, progress, and future directions.

Medical Medical Executive Executive Committee Committee

The Medical Executive Committee (MEC) advises the Clinical Center Director on clinical aspects of operations and develops policies governing standards of medical care in the Clinical Center. The group consists of Clinical Directors from each Institute and other senior clinical and administrative representatives.

Board Board of of Scientific Scientific Counselors Counselors

The Board of Scientific Counselors (BSC) 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 Centers intramural clinical research programs. This is accomplished through periodic visits to the laboratories, assessing the research of, and evaluating the performance of, independent investigators. The purpose of this group is to secure unbiased and objective evaluation of the independent research programs of the Clinical Center and the work of individual scientists. Expert scientists from outside the NIH participate as members of this review group. The Clinical Center has a small portfolio of independent research conducted by the clinical departments which provides the essential clinical support services to Institute clinical researchers.

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Advisory & Review Groups

Scientific Scientific Management Management Review Review Board Board
The Scientific Management Review Board (SMRB) was authorized by the NIH Reform Act of 2006 and signed into law by the President in January 2007. This act was the first omnibus reauthorization of NIH in 14 years. A major element of the Reform Act of 2006 was the new authority it gave to the NIH Director to improve program coordination, assemble and analyze accurate data, implement strategic plans based on institute- and center-determined priorities, ensure proper allocation of resources, and further maximize investigator-initiated research in high impact and emerging research areas. Former NIH Director Elias A. Zerhouni, M.D., nominated individuals to serve as members of the SMRB and the Board was announced in September 2008. The SMRB continues to examine the NIH's organizational structure and balance and will provide recommendations for enhancing the agency's mission through greater agency flexibility and responsiveness. Three workgroups have been established to conduct an in depth review of specific areas of the NIH. One workgroup, the NIH Clinical Center and Intramural Research Program (CCIRP), has focused specifically on the Clinical Center and the Intramural Program and has sought input from Clinical Center leadership and past and current members of the NIH Advisory Board for Clinical Research (ABCR).

Joint Joint Commission Commission

The Joint Commission evaluates and accredits nearly 16,000 health care organizations and programs in the United States. An independent, not-for-profit organization, the Joint Commission is the nation's predominant standards-setting and accrediting body in health care. Since 1951, the Joint Commission has maintained state-of-the-art standards that focus on improving the quality and safety of care provided by health care organizations. For example, standards are set for such areas as medical and nursing staff credentialing, fire and emergency responses, patient safety, and continuous improvement of the services provided for patients. The Clinical Center received full accreditation in 2009.

Association Association for for the the Accreditation Accreditation of of Human Human Research Research Protection Protection Programs, Programs, Inc. Inc. (AAHRPP (AAHRPP) )
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is a nonprofit organization that offers accreditation to institutions engaged in research involving human participants. Incorporated in April 2001, AAHRPP seeks to ensure compliance and raise the bar in human research protection by helping institutions reach performance standards that surpass the threshold of state and federal requirements through self-assessment, peer review, and education.

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Customers/Stakeholders - Institutes
What What are are the the Institutes Institutes Telling Telling Us? Us?
The NIH is composed of 27 Institutes and Centers (ICs) whose research activities include basic research that explores the fundamental workings of biological systems and behavior, studies that examine disease and treatments in clinical settings, prevention, and population-based analyses of health needs. The Office of the Director, NIH (Deputy Director for Intramural Research) provides leadership, oversight, and coordination for the enterprise. The Clinical Center supports the intramural clinical research efforts of the 17 ICs whose clinical programs are on the Bethesda campus. In FY 2009, there were 1,451 active protocols implemented with Clinical Center resources and support; this is a growth of 122 protocols, or 9 percent over the past five years. Institute Planning Meetings A set of themes garnered from ongoing discussions with the Institute Directors, Scientific Directors, and Clinical Directors, compiled after the Fall Institute/Clinical Center planning meetings, summarizes information gleaned into a list of key areas of growth and change in the intramural clinical research program. The themes are provided to CC department heads and informs them as they are preparing their annual budget requests. Ultimately, the information derived from interactions with the Institutes guides the Clinical Center in developing its operating plan and in allocating its resources effectively. Understanding what the Institutes are telling us and disseminating this information to Clinical Center department heads allows the Clinical Center to align its resources to Institute priorities in order to provide optimal support for both clinical research and patient care. Since new Institute initiatives are generally implemented over multiple years, many of the themes (areas of growth or change) documented in this report represent affirmation of Institute requests from prior years with updates provided. With continued budget constraints projected for FY 2010 and beyond (as discussed elsewhere in this document), Institutes and their investigators will need to collaborate with the Clinical Center to refine the timing of resource requests and prioritize new initiatives in the context of ongoing clinical programs.

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Customers/Stakeholders - Institutes
What What are are the the Institutes Institutes Telling Telling Us? Us? Themes from 2009 Fall Planning Meetings
1. Prioritization of Clinical Research In a time of increasing financial pressure, the NIH Intramural Research Program needs to develop strategies that set priorities for the identification of which proposed clinical research projects should be conducted. Whereas individual ICs can set priorities for their own projects, the IRP also has to be able to look across Institutes and Centers to make difficult decisions about priorities. With the Clinical Centers budget remaining relatively flat, the opportunities for program expansions and new initiatives are severely limited. Given current budget constraints, the CC will be unable to support new initiatives unless other projects are downsized or terminated. The prioritization has to occur at the NIH IRP level with input from the CC. The CC should identify IC projects that are not using resources efficiently and identify IC projects that consume large amounts of resources. An effective, coordinated trans-NIH planning process is necessary for optimizing utilization of the Clinical Center within the finite envelope of available resources. 2. Marketed Pharmaceutical Agents Used Off-label as the Subject of Research Studies The Intramural Working Group and the Management and Budget Working Group have required the CC to request that individual ICs pay for marketed agents that are being studied for off-label indications. Alternatively, it was suggested that the ICs work with Pharma to have the agents donated to the CC through the NIH Foundation, or that the IC develop Cooperative Research and Development Agreements (CRADAs) or Clinical Trial Agreements which include the Pharmaceutical manufacturer contributing the drug to the study. This past year the CC has worked closely with the Foundation for the National Institutes of Health to make arrangements for donations of marketed drugs being studied for other than their labeled indications. Numerous IC customers and stakeholders have found that the requirement for the IC to purchase agents restricts the number of studies that can be implemented, and have asked that this policy be revisited by the NIH leadership and oversight groups. In some cases, the cost of off-label drugs that are the subject of a protocol have been recovered through CRADAs with industry. However, this process often delays the study. In some cases, changes the scope of the study occur, which may detract from the studys primary objective.

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Customers/Stakeholders - Institutes
What What are are the the Institutes Institutes Telling Telling Us? Us? Themes from 2009 Fall Planning Meetings
3. New Programs May Have Substantial Impact on Resources and Services Certain new programs currently in the planning process (e.g., the NHLBI percutaneous trans-thoracic aortic valve replacement program, and/or the traumatic brain injury post traumatic stress disorder [TBI/PTSD] initiative) are likely to result in increased demand on selected CC services. The aortic valve project will require specialized nursing, clinical laboratory, anesthesia, intra-operative, and post-operative skills. Similarly the TBI/PTSD initiative will require substantial imaging, rehabilitation, laboratory and psychiatric support. Though these programs have identified funding sources to support the initiatives (NHLBI will provide resources necessary for the aortic valve replacement program while Congress has made resources available to Department of Defense and the Uniformed Services University for the Health Sciences for TBI/PTSD), the Clinical Center must work closely with these programs that will require additional infrastructural support and coordinate planning across ICs who may experience increased demand on some consult services. 4. Assessing the Impact of the Recruitment of New Tenure and Tenure Track Investigators on Clinical Support Services Several ICs are recruiting tenure and/or tenure-track clinical investigators. When these individuals arrive, we anticipate significant increases in the number of clinical protocols, and therefore, increased demand on Clinical Center support services. Systematic use of the Resource Planning Tool, created by the CC and completed by ICs as part of the Institute Planning Meeting process, may provide valuable quantitative and qualitative information about the resources required to support new investigators and their protocols.

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Customers/Stakeholders Patients
What What are are the the Patients Patients Telling Telling Us? Us?
Patients come to the NIH from every corner of the United States seeking answers to their scientific and medical questions. They represent both genders and all ages, races, cultures, and socio-economic groups. In FY 2009, there were 10,315 new patients, 6,426 inpatient admissions (an increase of 5 percent from FY 2008) and more than 96,000 outpatient visits (an increase of 7 percent from FY 2008). On average, there are 161.6 patients (an increase of 9 percent from FY 2008) in the hospital per night, and their length of stay averages 8.7 days (a 3 percent increase from FY 2008). Over the last six months (July December 2009), the average daily census was 164.5. In FY 2009, 1,504 new research volunteers, healthy recruits for inpatient and outpatient studies, were enrolled through the Clinical Centers Office of Communications, Patient Recruitment and Public Liaison Office and its Clinical Research Volunteer Program, the latter providing a pool of healthy volunteers available (through a registry) for all principal investigators. In FY 2009, the Clinical Research Volunteer Program registry included 43,970 volunteers; 1,808 individuals were added in FY 2009. The program processed 19,011 payment transactions. 1. Surveys As partners in the clinical research process, our patients are well-positioned to provide the Clinical Center with valuable information about the quality of care and services provided to them as research participants. The Clinical Center relies on a variety of techniques to elicit our patients perceptions of their experiences here at the CC. As part of the Clinical Centers departmental operational review process, patients were queried about their personal impressions and experiences regarding specific departments. Information from these surveys was used to inform the reviews of these departments. Patients also are surveyed continuously upon discharge through a collaboration with National Research Corporation (NRC+Picker). Patients receive a survey within a month of discharge assessing perceptions of their CC experience using the following dimensions of care: Emotional Support; Respect for Patient Preferences; Physical Comfort; Information, Education and Communication; Coordination of Care; Involvement of Family and Friends; Continuity and Transition; and Access to Care. Our patients consistently rate the quality of care provided in the Clinical Center as above the 95th percentile and indicate that they would highly recommend that their family and friends come to the Clinical Center as appropriate. Areas for improvement that have been identified include assuring that our patients know the physician who is managing their care, improving the quality of housekeeping services in the CC, and assuring that our patients have appropriate resources available to them to discuss their fears and anxieties.

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Customers/Stakeholders - Patients
What What are are the the Patients Patients Telling Telling Us? Us?
In addition to surveys, several processes exist to provide real-time information about how patients view their experience at the Clinical Center. 2. Patient Representative The Patient Representative serves as a critical link between the patients and the hospital. Every effort is made to assure that patients are informed of their rights and responsibilities and that they understand what the Clinical Center is, what it can offer, and how it operates. The volunteers working with the Patient Representative visit newly admitted patients, and proactively seek to identify critical patient care and clinical research issues that Clinical Center patients are facing or may face as a result of participating in the research process. In 2009 common issues faced by patients included: problems with travel; misunderstandings of the voucher office processes; access to needed information; problems with routine procedures; and issues between patients and staff. 3. Online Feedback Mechanism Patients have the capacity to provide online feedback to the Clinical Center leadership about their experience. Every patients bedside computer has the Patient Portal which provides access to the internet and links to educational materials and a patient feedback form. The form allows patients to alert CC leadership on both strengths of the organization as well as opportunities for improvement. 4. Patient Advisory Group The Patient Advisory Group was established in 1998 when some of our patients were invited to provide their perspectives on the design of the new Clinical Research Center. The momentum of the Patient Advisory Group continues to increase; at least 20 patients and/or family members attend meetings which are held twice annually. These individuals represent patients who live locally, as well as those who travel long distances to participate in NIH clinical research studies; some patients attend by teleconference. Meetings are open to all patients and family members, and the discussions from these meetings help identify issues of concern and recommendations that improve efforts to provide the highest quality research and patient care services. One member of the PAG represents the patients viewpoint at each meeting of the NIH Advisory Board for Clinical Research. Patients also share their voices in Clinical Center coursework that focuses on the patients vital role as a participant in clinical research including: (1) The Introduction to the Principles and Practice of Clinical Research and (2) The Ethical and Regulatory Aspects of Clinical Research. In 2009, the PAG provided advice and feedback on topics including the following: opportunities for service excellence including improvements to clinic wait times and recommendations for enhancements to the physical environment; evaluation of bar-coding; electronic communication between patients and physicians; patients and the media and options for increasing awareness of the Clinical Center nationally. 30

Customers/Stakeholders - Employees
The Clinical Center FY 2008 turnover rate of 12 percent matches the average rate for Maryland hospitals. Nearly 11 percent of eligible CC employees retired last year, which is a significant decline from the prior years rate of 23.1 percent. Reflective of the larger federal workforce, the CC workforce also is getting older. Over the past eighteen years, the average age of CC employees increased by 6.2 years to the current average of 45.8 years. Occupational groups with the greatest increases in average working age have been targeted for strong succession planning. The role of mentoring and understanding a multi-generational workforce are two employee competencies that have gained value and focus. Quality of worklife also is increasing in importance and a six-session series on different aspects of the topic were part of this years monthly CC brown bag program. As part of the Clinical Centers goal to develop a more robust succession plan, the executive coaching program developed three years ago now includes a focus on middle management development. This focus provides individual coaching for promising middle managers and has become a very popular and competitive program. Two new competency-based courses Supervisory Essentials and Management Essentials provide a common developmental foundation for strengthening the administrative leadership role in the CC. Clinical Center staff are committed to providing the best service to our patients and their families. In sustaining this value both physical and administrative projects were launched to improve the patient experience in the CC. Under the umbrella of the service excellence initiative both front-line employees and clinical management leaders were involved in developing improvement projects. Examples include improving signage, escorting patients through complex procedures, and smoothing hand-offs between departments to enhance patient care coordination. This year over 600 new employees, interns, and volunteers completed the Clinical Centers New Employee Orientation. The CC continues to attract excellent professionals with diverse backgrounds and a strong commitment to clinical research. To ensure a strong orientation for new members of the CC workforce, ethics, library resources, and a new diversity program were integrated into the New Employee Orientation. New employees continue to express their excitement over coming to work at the Clinical Center. The Clinical Center atmosphere, both the dedication of the staff and the patient care mission, often are cited by new employees as reasons for seeking employment at the CC and seasoned employees highlight them as explanations for their continued service. One recent hire stated that he is enjoying every minute of my time at the Clinical Center. Another new employee commented that I always wanted to work at NIH with its committed professionals, and have found that the organization exceeds my expectations. This feedback only strengthens the CCs commitment to providing a quality work environment to attract and retain high performing employees.

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Customers/Stakeholders Clinical Fellows

Clinical Fellows Committee Throughout 2009 a group of clinical fellows representing all Institutes met quarterly with Clinical Center Director John Gallin. Established in 2004, the Clinical Fellows Committee (ClinFelCom) provides a communications venue for clinical fellows to present issues and initiatives involving the Clinical Center to Dr. Gallin and other staff. As in prior years, ClinFelCom achieved important successes in 2009. This includes advocating pre-approval for acceptance of travel awards and competitive scholarships to scientific conferences. Prior to this initiative, clinical fellows found it challenging to determine when, how and from what organizations they could accept travel awards and competitive scholarships to attend scientific conferences. The CC worked with members of ClinFelCom and the Graduate Medical Education Committee (GMEC) to obtain pre-approval by the NIH Ethics Advisory Committee for specific awards and scholarships from professional organizations to which clinical fellows would normally apply. As a result, the overall vetting and approval process for accepting awards has been streamlined. Additionally, several information technology issues continue to be addressed by a subcommittee working with Clinical Center informatics staff. This includes a comprehensive new computerized sign-out tool, which has passed the betatesting phase and has been implemented by Critical Care Medicine Department ICU fellows, NIAID, and NHLBI services. ClinFelCom also has worked to increase participation among clinical fellows. The co-chairs worked with each program director to identify additional clinical fellows interested in attending ClinFelCom meetings. This has increased the committees ability to hear from clinical fellows about what the CC can do to help improve and enhance their training experience. For example, ClinFelCom identified the need for increased awareness about resources and policies affecting clinical fellows. As a result, ClinFelCom will be working directly with CC staff to improve the format and content of website material currently accessible by clinical fellows. This will be a key initiative in the coming year. Furthermore, ClinFelCom members continue to serve as representatives on key Clinical Center committees, including the CC Quality and Infection Control Committees, Graduate Medical Education Committee, Medical Executive Committee, and Department of Clinical Research Informatics Fellow Advisory Board.

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Customers/Stakeholders External Partners

Extramural Clinical Investigators In support of the NIH initiative to invigorate clinical research, the CC focused recent efforts on the expansion of programmatic opportunities to include extramural investigators. In September, the CC launched a new pilot program called the Sabbatical in Clinical Research Management which invites extramural investigators and established researchers to perform an independent study with leaders and managers at the CC, NIH, and Dept. of Health and Human Services. Also, the 16th offering of Introduction to the Principles and Practice of Clinical Research (IPPCR) course occurred this year. Almost 1,300 students enrolled with greater than 50 percent participating at remote locations, both nationally and internationally. Another popular course, Principles of Clinical Pharmacology has 813 students enrolled this year, also with over 50 percent participating at remote national and international locations. Two NIH teams traveled to China to teach a version of the IPPCR course and a version of the Principles of Clinical Pharmacology course to distinguished students. In early November, the 7th annual Clinical Investigator Student Trainee forum (CIST) was held with 307 participants, who are taking a year off from medical school to gain a clinical research experience; this includes students in the NIHs Clinical Research Training Program. This academic forum is supported with public and private funds from the Howard Hughes Medical Institute, Doris Duke Charitable Foundation, Sarnoff Endowment for Cardiovascular Sciences, Fogarty International Center/Ellison Foundation, and NIH. The purpose of this forum is to emphasize the critical importance of translational and clinical research, and training the next generation of clinician-scientists. In addition to clinical research training efforts, the NIH Bench-to-Bedside program launched its 12th cycle with funding from intramural ICs and these 7 donors: the Office of Rare Diseases; Office of Research on Womens Health; Office of AIDS Research; National Center on Minority Health and Health Disparities; National Center for Research Resources; the Food and Drug Administration; and Office of Behavioral and Social Sciences Research. This years portfolio of projects represents a robust sampling of intramural institute investigators partnering with extramural clinical researchers at academic medical centers, both U.S. and abroad. Since the programs inception, more than 500 investigators have collaborated on 152 funded projects. Advocacy Groups Patient advocacy groups and disease-oriented foundations offer important resources for understanding the needs of various patient populations. The Clinical Center will promote interactions with these groups to better understand how to support NIH patients and to conduct meaningful outreach and referral. Industry Collaborations with industry partners represents a desirable new opportunity for fostering translational research. Conflict of interest considerations must be managed carefully as such partnerships are implemented.

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Customers/Stakeholders External Partners

Referring Physicians Good bi-directional communication with referring physicians is essential to continuity of care and maintaining open and effective patient referral networks. Referring physicians have commented that the NIH should improve the provision of discharge reports to provide timely and proactive patient follow-up. In 2008 the Clinical Center conducted an extensive assessment of referring physicians perceptions of the timeliness and utility of communication with NIH physician investigators. Several areas for improvement were identified and the Clinical Center, working with the Medical Executive Committee, has launched an organizational effort to develop strategies to enhance communication and interactions with referring physicians. Accomplishments in 2009 include: Improved functionality within the existing Admission, Travel, Voucher request database to enable requestors to enter patients referring physicians and other outside physicians names and addresses for new patients. A link to the National Provider Identifier database was added to the Admission, Travel, Voucher new patient registration request screen. Medical Record Department staff are conducting a complete audit of all outside physician contact information for all active patients currently available in CRIS. This data will serve as a referring physician database. An automated fax software module which links directly to existing transcription, medical record completion and tracking databases has been purchased and will be configured and implemented in the Medical Record Department. This will provide the ability to fax information from a patients medical record to referring physicians in a timely manner. Database enhancements are being made to enable Medical Record Department staff automatically to mail out a cover letter and a copy of patients first registration reports to outside physicians. A medical secure email system has been developed; this will enable NIH clinicians to communicate with patients via secure email. This secure email system also will be utilized to follow-up with patients when necessary to obtain complete addresses for outside physicians. A new referring physician website is in development by the Office of Clinical Center Communications. Referring physicians will be notified of this new tool in the initial letter that is mailed to them following a patients visit to the Clinical Center.

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