Risk Identification/Stratification Tool Development

Risk Identification/Stratification Tool Development

An Accredited CE Provider

Product: Collaboration

Challenge:

The client, a large specialty society, develops numerous professional resources including clinical practice guidelines, position statements and health policies.  The large number of activities produced, combined with limited staff time and expertise caused a concern over the possibility of missing potential conflicts of interest that would pose both legal and regulatory risks, as well as damage to their excellent reputation for producing high quality educational products and services that are free from conflict of interest (COI) and/or commercial bias.  

The client reviewed their existing COI procedures and determined that their entire COI review process needed to become much more robust in order to assess, manage and mitigate potential risks.   

Why CME Peer Review :

The client contacted and eventually contracted with CME Peer Review because of their reputation as a knowledgeable and experienced company whose core business is to develop evaluation processes and tools to determine if activities meet the client’s high standards for educational integrity and regulatory compliance. The client was impressed with CME Peer Review’s experience developing COI processes, their competent staff and their independence from any commercial interest.  

Approach:

CME Peer Review began the process by working with the client's staff to identify key stakeholders within the organization. These stakeholders were interviewed by CME Peer Review to assess their perceived issues and problems with the existing COI processes and determined what level of risk where they willing to accept.   Goals, timeline and measures of successful outcomes for the process were created.  Terms were clearly described to avoid confusion or misunderstanding.

In addition, the client reviewed all relevant internal policies and CME Peer Review reviewed external ACCME criteria and other relevant regulations, guidelines and codes to confirm that all possible risks were taken into consideration.  They also researched the literature to identify samples of “best practices” for COI mitigation strategies. 

In summary, the following steps were taken: 

  1. Identified key stakeholders within the organization
  2. Interviewed the stakeholders to identify the most important issues, including what level of risk are they willing to accept
  3. Established goals, timelines and successful outcomes for the process
  4. Defined terms to ensure clarity and reduce any misunderstanding
  5. Reviewed all relevant  internal policies
  6. Reviewed ACCME criteria and other relevant regulations, guidelines and codes
  7. Reviewed current literature to identify best practices for COI risk management
  8. Determined areas of risk for each activity under consideration
  9. Stratified and prioritized the risks 

Solution:

Standardized forms and assessment tools were developed by CME Peer Review to assess, document and analyze the various activities and their potential for risk.  Activities were categorized and stratified within each category and assigned a rating of low, medium or high risk.  A total score would be produced at the end of the risk assessment which would help to determine the need for more independent review of the content prior to finalizing the product or activity.   

In summary, the following solutions were implemented:

  1. Forms and tools were developed by CME Peer Review and approved  by the client to assess and catalogue the risks
  2. Person(s) responsible for completing the form(s) were identified and their roles were clearly explained to them and summarized on the form.
  3. A pathway was created by CME Peer Review to guide staff as to what needed to be done with the information, including what actions needed to be taken if a potential COI emerged.  The pathway was copied and laminated for posting, as desired. 

  

Outcome:

The standardized forms developed by CME Peer Review enabled the client to implement an objective method to assess and manage a risk stratification process that was concise and easy to complete.  The new process created a clear pathway to mitigate any potential COI.  This took the burden off the CME staff and the CME Director was now able to streamline the decision-making process for determining potential risk with the added knowledge of what level of risk would be tolerated by the organization. 

CME Peer Review developed a generic version of this tool to make available to others who have similar risk stratification needs.