Compliance Investigations 101

When it’s time to conduct a compliance investigation, it’s critical to have a plan in place. Here’s a quick outline of some key steps to help you with your investigative efforts.  

Preparation:  

  • Establish a Team: Identify individuals with the necessary skills (legal, HR, subject matter experts, etc.) to conduct a thorough investigation. 
  • Define Roles: Clearly assign responsibilities to each team member (lead investigator, interviewer, document reviewer, etc.). 
  • Develop a Plan: Outline the scope of the investigation, key questions to be answered, and a timeline for completion.    

Initial Assessment:  

  • Review the Report: Thoroughly examine the initial complaint or report that triggered the investigation. 
  • Gather Preliminary Information: Identify individuals involved, relevant documents, and potential sources of evidence. 
  • Assess Initial Risks: Determine the potential impact of the alleged violation and any immediate actions needed to respond. 

Investigation:  

  • Document Collection: Secure and preserve relevant documents, emails, records, and any other evidence. 
  • Interviews: Conduct confidential interviews with the complainant, witnesses, and other relevant individuals. 
  • Background Research: Gather information about the individuals involved, their roles, and any prior incidents. 
  • Data Analysis: Analyze collected data to identify patterns, inconsistencies, or potential violations. 

Documentation:  

  • Detailed Notes: Maintain thorough records of all interviews, document reviews, and investigative activities. 
  • Chain of Custody: Ensure proper tracking and preservation of evidence to maintain its integrity. 
  • Confidentiality: Protect the confidentiality of sensitive information and individuals involved. 

Analysis and Findings:  

  • Review and Synthesize Evidence: Carefully evaluate all collected evidence to reach well-founded conclusions. 
  • Identify Root Causes: Determine the underlying factors that contributed to the compliance issue. 
  • Assess Severity: Evaluate the impact of the violation on the organization, individuals, or stakeholders. 
  • Summarize Findings: A draft summary of findings could include summaries of the (i) complaint/allegation, (ii) investigation process (iii) outcome, substantiated or not, (iv) what corrective actions were required, if any, (v) the status of the investigation, closed, referred to Counsel, or external agency.   

Reporting and Remediation:  

  • Prepare a Report: Document the investigation findings, conclusions, and recommendations for corrective action. 
  • Present Findings: Share the report with relevant stakeholders, such as senior management, legal counsel, or the board of directors. 
  • Implement Corrective Actions: Develop and implement a plan to address the identified compliance issues, including policy changes, training, or disciplinary measures. 

Monitoring and Prevention:  

  • Track Progress: Monitor the effectiveness of corrective actions and ensure ongoing compliance. 
  • Continuous Improvement: Regularly review and update compliance policies and procedures to prevent future violations. 

Important Considerations:  

  • Objectivity: Maintain impartiality throughout the investigation to ensure fair and accurate findings. 
  • Legal Counsel: Consult with legal counsel as needed, especially for complex or sensitive investigations. 
  • Confidentiality: Protect the confidentiality of the investigation and sensitive information involved. 
  • Timeliness: Conduct the investigation in a timely manner to address issues promptly and minimize potential harm. 
  • Transparency: Communicate openly and honestly with relevant stakeholders throughout the process. 

Looking to take your efforts a step further? Reach out to Healthicity’s Compliance Advisory Services to learn how our team can help you manage or conduct a Compliance Investigation. 

 

To download this blog post as a pdf, click the button below.

Download Here

Questions or Comments?