Conducting Internal Investigations In Healthcare Compliance Using Ten Guiding Rules

Conducting an internal investigation may be a necessary approach to resolve concerns or allegations reported through the company’s compliance hotline. There are a number of guiding rules for conducting internal investigations and failure to follow them could seriously compromise an investigation.

Being aware of theses guiding rules is particularly important for those who do not have a strong background as a healthcare compliance investigator.  The checklist below provides ten guidelines to follow when conducting an internal investigation.

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  • Need to Know. The “need to know” standard is a general rule that all internal investigations or inquiries should follow. This means all discussions regarding the investigation should be restricted to a “need to know” basis and no sharing of information regarding the predication, direction, or findings of the process with any unauthorized parties. In any inquiry, the facts will dictate how to address the issue.
  • Control and Track Information. All hotline reports should be stamped, logged, and numbered as part of the records management and maintained in a secured location. Also, it is important to not use original documents. When possible, work with copies, not original documents.
  • Fully Debrief Complainants at the Beginning.  All complainants need to be fully debriefed as to the basis of their allegations, concerns, and complaints.  All facts should be gathered promptly. This may not be an option if your hotline service does not provide anonymous follow-up communication. Hotline services that do provide this option, can facilitate debriefing complainants through an anonymous communication channels that allows the compliance officer to ask the complainant questions and request more information that is key to the investigation.
  • Chain of Custody.  All evidence obtained during an investigation must be tracked so that it is never outside of the control of the investigation.  This is referred to as maintaining “chain of custody.”  Failure to maintain this chain of custody may result in the evidence being disallowed in a formal adjudicative process.
  • Be Fair and Impartial. The process of conducting the investigation must be a fair and impartial review of all relevant facts.
  • Include Management’s View. Include management’s views as part of the report and do not rely solely upon representations of staff.
  • Exercise Discretion. It is very important for the investigator to be discreet in gathering pertinent facts.  In a confined work environment, it is easy to “telegraph” information about the investigation that could easily undermine its effectiveness.
  • Stay Focused and Flexible.  Investigators must never lose sight of the purpose and objective of the investigation.  This means staying focused on factors relating to the complaint and not being distracted by extraneous information. It is equally important to not be inflexible to changing fact patterns or conditions.  This is not meant to conflict with the previous point but to recognize that under certain circumstances deviating from the guidelines and investigative plan may be necessary. Remaining too narrowly focused may result in missing even more significant issues than those that predicated the original investigation.  In many cases, the investigation may identify problems related to the original complaint or allegation.
  • Be Comprehensive. For most investigations, there is one chance, and so it is important that everything be done right the first time. It must be comprehensive enough to answer all the questions raised in the predication, as well as sufficient to identify any pervasive or systematic problem that may have caused the problem.
  • Prevent Retaliation.  One of the worst outcomes of an investigation is to have retaliation or retribution against the original complainant or witnesses.  This issue is specifically addressed in the OIG Compliance Guidance.  It is also something that …

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