Over the course of its 100-year history, the Henry Ford Health System (HFHS) has established a reputation for healthcare excellence and research innovation. The fifth largest employer in the Detroit metro area with approximately 23,000 employees, HFHS comprises five hospitals, a physician medical group, a physician network and a health insurance plan. More than 150 medical specialists and scientists associated with HFHS participate in hundreds of research projects. These activities are supported by $55 million in external and internal funding awarded each year. Additionally, a large pool of Continuing Medical Education (CME) professionals teaches courses and seminars.
An important role of the HFHS Compliance Office is to implement effective conflict of interest (COI) policies and procedures for HFHS staffers that enter into external relationships. It is also tasked with obtaining and tracking COI disclosures for thousands of “high-risk” employees, whose positions or outside activities increase the possibility that they could have a conflict in the future. For several years, the office used both an automated and a paper-based system for managing COI disclosures. The “homegrown” automated solution served much of the organization; however, it was based on a process management program not specifically designed to manage COI activities. Consequently, several operational deficiencies made its continued use impractical for HFHS. For example, the system was incapable of consolidating all COI functions across the entire HFHS organization and could not be accessed from outside the HFHS computer network. Desired capabilities, such as questionnaire branching and assignment of mandatory questions, were not available within the legacy software. In addition, the costs of contracting with an outsourced IT firm for program maintenance were growing each year. The automated COI system did not offer reviewers realtime access to the disclosures of employees, and this meant disclosure forms and data were neither easily accessible nor readily available. Because many high-risk HFHS employees required repeated follow-up, the Compliance Office spent too much time tracking outstanding forms, and not enough time managing conflicts. For the Governance, CME, and Insurance Plan departments at HFHS, the Compliance Office relied on a cumbersome paper-based system that made it difficult and timeconsuming to oversee COI activities efficiently. Further complicating matters was the inability of the Compliance Office to efficiently aggregate data collected by its separate automated and paper-based systems.
“We needed a sophisticated and comprehensive tool for streamlining COI processes that would also be simple to learn and use,” says Ron George, retired Chief Compliance Officer and current compliance consultant at HFHS. “So it was important for us to partner with a vendor that offered a proven solution and track record.”
At HFHS, the administration of COI processes was clearly hampered by the lack of a single centralized, electronic disclosure system. The organization’s legacy automation was incapable of consolidating its COI disclosure management processes across the enterprise and converting the unwieldy paper-based system into an electronic one. These factors were the primary drivers in the decision to deploy a new COI management solution. The Compliance Office was interested in implementing a proven COI-specific system that would create efficiencies for managing the disclosures of thousands of physicians, researchers, and other high-risk employees who needed to be entered into the system, tracked and followed-up with. HFHS required a solution that would help control costs by eliminating outsourced IT support, as well as to facilitate compliance with the more stringent National Institutes of Health (NIH) disclosure regulations which took effect in 2012. The Compliance Office determined that it needed a new comprehensive COI management solution that would support the following activities:
- Recording disclosure data from multiple sources and storing it in a single electronic COI “clearinghouse”
- Creating customized multi-level branching questionnaires with mandatory questions based on individual employee characteristics
- Monitoring employees at high-risk for COI relationships and electronically initiating the disclosure process
- Tracking email correspondence with employees regarding disclosure
- Providing seamless and user-friendly online access to COI system by users regardless of their physical locations
The Compliance Office secured buy-in for deploying a new COI management solution after establishing a committee of stakeholders to redraft HFHS’s COI policies and procedures. A table that described policy requirements— and the associated technology needed to execute them—was created and approved. After evaluating the RFP responses of four prospective vendors and presentations by the top two candidates, the committee selected the COI-SMART software offered by HCCS, now a HealthStream Company, a leading provider of healthcare compliance training and tracking solutions. COI-SMART is a customizable and scalable program that automates cumbersome manual COI processes. The intuitive and easy-to-learn application has enabled hundreds of healthcare organizations to efficiently track and manage conflicts of interest while complying with the latest federal COI regulations.
HFHS didn’t have to wait long to see positive results. The Compliance Office reported benefits right after its initial roll out of COI-SMART. Prior to COI-SMART implementation, for example, it took up to five months to obtain a full disclosure rate of 100 percent for high-risk employees. After COI-SMART implementation, it took only two months to obtain a full disclosure rate of 100 percent for high-risk employees. Furthermore, fewer Compliance Office staff resources were required to manage COI activities. The deployment of COI-SMART has reduced the need for highly paid panel members to spend as many hours reviewing disclosures, while enhancing the Compliance Office’s ability to identify and resolve risks that might otherwise potentially harm the organization. The solution also has also proven more cost-effective than the previous “homegrown” automated system, in part because HFHS no longer needs to contract with a third-party IT company for program support. The system provided a clear and quick Return on Investment (ROI), Most at HFHS would agree that the decision to deploy COI-SMART was simple. “We couldn’t have chosen a more accommodating partner for this immense project than HCCS. When we’ve made feature enhancement requests, we’ve never been told, ‘No, that’s not part of the system,’” says George. “Instead, they say, ‘We understand. Let’s see how we can accomplish that for you.’” From start to end, he adds, HCCS has been supportive in helping HFHS realize its forward-looking vision for a COI management solution that automates processes, streamlines procedures, saves money and reduces risk.