COI COMPLIANCE: THE CHALLENGES
Via Christi Health is the largest provider of healthcare services in Kansas. Based in Wichita, the health system includes: 10 hospitals; 17 senior care facilities and programs; more than 10,000 employees; and more than 400 physicians and mid-level providers. Hundreds of Via Christi employees are involved in innovative clinical research that involves millions of dollars in grants and funding. With such a comprehensive service offering and so much involvement in research, Via Christi is committed to maintaining a diligent and centralized financial conflict of interest (COI) disclosure and reporting program.
The organization has a clear COI policy, a corporate responsibility officer and a Research Compliance Committee to help it comply with internal and governmental COI regulations. However, until 2009, Via Christi Health collected and tracked COI disclosures among its many physicians and employees with a labor-intensive paper-based system. Then, over a period of several years, the organization tried home grown and, later, commercially available online survey systems to meet COI management obligations. They found that each option fell short of their requirements. Even a popular, generic web-based survey solution wasn’t as efficient or easy-to-use as the staff had hoped, requiring significant manual effort on the back end. In fact, Corporate Responsibility Officer Shelley Koltnow vowed, “Never again!” as she waded through spreadsheets, emails and voicemails to try to track key COI details.
A NEW DIRECTION
In frustration, Via Christi’s compliance staff searched for a new online COI system. They found COI-SMART from HCCS, a HealthStream Company, a scalable, fully integrated application that provides comprehensive tools for tracking and managing COI disclosures. A demonstration of COI-SMART was all it took for staff members to enthusiastically support its implementation. They instantly recognized the value of its logic, and the ability to streamline disclosure communication right in the software—without the need to create separate spreadsheets or keep tabs on emails and voicemails. COI-SMART now allows Via Christi’s compliance staff to develop multi-level questionnaires and automate the assignment of reviewers, plus take advantage of data mining tools for auditing, tracking and reporting on potential COI.
“I remember being on the phone, pressing ‘mute’ and saying, ‘When can we get this!’” says Lynette RauvolaBouta, Senior Vice President of Mission Integration. Unlike the Web-based survey tool formerly used by Via Christi, COI-SMART is a flexible COI-specific application. That means Via Christi and HCCS/HealthStream staff can fluently communicate to configure a questionnaire best suited to Via Christi’s needs.
“The responsiveness and service attitude of the HCCS/HealthStream staff was outstanding, during go-live and going through the process of building our questionnaire. That’s important, because there’s a lot of work involved in building it,” notes RauvolaBouta. “Even with a good product, you need a service-oriented company behind it.”
Other benefits of COI-SMART include:
- Ease of use. Via Christi staff was frustrated by their previous COI disclosure survey system due to its inability to tailor and streamline narrative responses. With COISMART, when a respondent answers “yes” to certain disclosure questions, a followup question appears on the screen for the user to provide more detail. A “no” answer leads to the next applicable question.
- Integration. All communication concerning COI disclosure is conducted within the COI-SMART application. If investigators or compliance staff have questions, they can be addressed within COI-SMART, without requiring the use of other applications such as email. As a result, all details about a particular survey response are in one easy to-access location.
- Administration. Compliance staff can easily determine who has completed the survey, who has started, and who has yet to begin. Staff can track which physicians and employees have financial COI disclosures and retrieve that information for reporting or auditing. Management plans can be crafted, distributed, and accepted by respondents.
- Compliance. Most importantly, COI-SMART’s transparency demonstrates that Via Christi takes compliance seriously, and is making a good faith effort to provide all required disclosure information in a timely manner.
Just prior to launch, the compliance staff asked a small pilot group of employees to test the COISMART system and requested their feedback. The reviews were overwhelmingly positive. Via Christi opened the survey to the rest of the organization just a few weeks later. Within the first 48 hours, nearly half of the 560 respondents had completed the survey. Within two months, 95% of the surveys were completed. Respondents include board members, committee members, physicians and executives. “It was amazing!” says Koltnow. Just a year earlier, using the generic Web-based survey tool, staff was still chasing surveys seven months later. In addition, within only a few months of implementation the automation saved Via Christi thousands of dollars in labor cost. Using a return on investment (ROI) worksheet, the organization has conservatively estimated that COI automation will save approximately $45,000 in the first year of use and at least another $55,000 in each subsequent year of use. Via Christi Health now is reaping both financial and time-saving rewards with the efficiency of COI automation. Staff cannot imagine managing COI disclosures manually ever again.