A capability in the CC context of strategic planning is a tool that enables research or research support. A new investigator who has unique expertise, a specialized piece of equipment that facilitates groundbreaking insights into clinical science, or a renovated suite of rooms that allows us to provide better care for a subset of CC patients are all examples of capabilities.
The CC has added or expanded a number of capabilities during the last three years. Some of these capabilities have been discussed in other parts of this plan, but several have not:
- Hospice suites – NEW
- Cellular engineering – TRIPLED CAPACITY
- Pediatrics observation beds – NEW
- Pediatrics hospitalist service – NEW
- Internal medicine service preoperative evaluation clinic – NEW
- Urgent transport capability – NEW
- Digital patient tracking – NEW
- Primary nurse model for out-patients – NEW
- Resources for research compliance and support – AUGMENTED
The Capital Investment Fund has also provided support for facility renewal that will serve us well over the coming years:
- Over the next two years, all in-patient rooms will be upgraded
- Nursing stations in the ACRF outpatient clinics will be remodeled to improve workflow
- Major investments have been made in electrical and mechanical (HVAC) systems to improve performance and mitigate the consequences of infrastructure failure
- Phased refresh of the Department of Laboratory Medicine
Additionally, through the well- established processes for prioritizing capital expenditures and leveraging the Capital Investment Fund provided by the NIH, major equipment purchases that would have been nearly impossible a few years ago are in process:
- CT scanning equipment to be located in the Critical Care Unit
- New mass spectrometer for the Department of Laboratory Medicine
- Next generation sequencing equipment for the Department of Transfusion Medicine
- Hybrid imaging suite for interventional radiology
- Positron Emission Tomography / Magnetic Resonance Imaging equipment
- Network upgrade
As part of our responsibility and, indeed, honor to work in the world's largest hospital dedicated solely to clinical research, all CC staff at every level of the organization are committed to exemplary service to our patients, families, researchers and the larger global community. At a local level and through stewardship of all CC departments as well as collaborative oversight of IC clinical research, efforts are sustained in promoting increased scientific integrity, public accountability, and social responsibility in the conduct of science at the CC.
These efforts are reinforced greatly with a newly established CC Research Support & Operational Compliance Office as a resource to investigator efforts to ensure rigor and reproducibility of research, reduce administrative burden, and engage in proactive risk management practices. Quarterly Morbidity & Mortality (M&M) Conferences for all CC and IC clinical staff engaged in patient care were introduced in 2017. M&M Conferences in U.S. hospitals originated more than 100 years ago. They have evolved to address various aspects of patient care such as complications, adverse events, death, medical errors, omissions and system problems. At the CC, unique patient care aspects related to clinical research studies are also included in M&Ms. Since 2017, these CC sessions have been extremely well attended and have promoted excellent dialogue and follow up among multidisciplinary professionals throughout the organization.
Pediatric Patients
Contemporary and anticipated advances in gene therapy and cellular engineering will drive new assessments of our ability to take care of younger and smaller pediatric patients. The science necessary to diagnose inherited rare diseases has progressed significantly. The ability to intervene early in the natural history of those disease processes is advancing rapidly as well.
As the world leader in rare disease research, the NIH is positioned to apply the principles of precision medicine early in the natural history of the disease, thereby allowing the child to avoid many of the complications and sequelae that accrue over time. Caring for these younger and smaller patients can only be done if patient safety can be assured. A thorough gap analysis between current capabilities and those required to care for younger patients safely is a near term goal. Subsequent steps will be determined by the results of this analysis.
Upgraded Network
The upgraded network is key to a number of future initiatives. Improvements in medication safety involve greater use of barcoding technology, robotics, and automated dispensing cabinets that are networked with our electronic health record. Extending the reach of the CC requires a comprehensive evaluation of the current and future potential of telemedicine and telehealth. In the past, extending the reach of the CC typically involved collaboration with outside investigators. The UO1 and Bench-to-Bedside programs facilitated collaboration between NIH and extramural investigators. Although these programs have resulted in important scientific accomplishments, efforts to increase use of the CC through these mechanisms have not been successful. If the CC is to be a national resource, it must become a more robust virtual resource. The CC will develop a new initiative, "CC Without Walls," that will leverage technology to extend the reach of the CC to more patients, more families, more clinicians, and more scientists.
Electronic Health Record
While developing new initiatives that rely on technology, every effort will be made to keep the CC's bread-and-butter information systems current and robust. Our current electronic health record, Clinical Research Information System (CRIS), is flexible and adaptable to many patient care and patient safety applications. Increasing the duration and frequency of training for users would reduce a significant number of the shortcomings noted in a recent in-depth evaluation by an outside contractor.
This study did recommend starting procurement planning for a major upgrade or replacement of CRIS in 3 to 5 years. The landscape of electronic health records is expected to evolve during this period. The CC needs to keep abreast of new developments if the major procurement is to meet the CC's needs for many years into the future.
Cellular Engineering
The CC will continue to expand cellular engineering capabilities. While capacity has nearly tripled in the last year, requests by investigators for more and varied products continue to grow. By the time 12E opens in 2021, the number of cell culture rooms will be doubled yet again. As our experience in the construction and maintenance of these facilities matures, the ability to provide hope to sufferers of even the most challenging and rarest of diseases will continue to grow as well.
Summary
Renewed investment by the NIH in clinical research facilities, new capabilities, and expanding old capabilities portend a bright future for the CC. The improved capabilities and facilities are key recruiting and retention tools that ensure the CC will remain the leader in first-in-human clinical research well into the 21st century.