Conducting Internal Investigations In Healthcare Compliance Using Ten Guiding Rules
Every concern reported through your compliance hotline must be taken seriously. But what happens when the allegation requires more information or speaks to a potentially systemic problem within your organization?
The answer is simple: you must undertake a robust internal compliance investigation. From identifying root causes of compliance failures to addressing broader issues within the organizational culture, these investigations can yield insights that drive meaningful improvements to your Compliance Program.
However, these investigations can be fraught with challenges. Bias, fear of retaliation, and privacy concerns make it difficult to access the information you need to pinpoint regulatory risks and make lasting changes.
These challenges leave many leaders wondering:
– What process should my compliance investigation follow?
– How can I ensure the process protects trust and respects individuals’ privacy?
– Where should I even start when undertaking an investigation?
This article exists to answer those questions and help make your next compliance investigation truly effective.
Process Checklist: 10 Steps to Conduct Effective Compliance Investigations
Our team has worked with more than 100 healthcare organizations over the last three decades: we’ve observed numerous common errors and oversights, as well as several factors shared by every successful project.
The following checklist distills that experience into ten principles every organization should follow when conducting an internal investigation.
Minimize Information Sharing
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 Start
Every complainant must 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 anonymous communication channels that allow the compliance officer to ask the complainant questions and request more information that is key to the investigation.
Maintain a 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 a “chain of custody.” Failure to maintain this chain of custody may result in the evidence being disallowed in a formal adjudicative process.
Ensure Fairness
The process of conducting the investigation must be a fair and impartial review of all relevant facts. This may require active steps to identify and mitigate potential bias within the team undertaking your investigation.
Address Management Perspective
Many investigations rely solely upon testimony and overlook the input of managers who may have a different perspective and relationship to compliance matters. Address this by soliciting and sharing management’s view within your report.
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 can create serious legal liability.
The compliance hotline is an essential tool that allows communication between a healthcare organization and its employees. However, hotlines are only effective if employees are confident that the organization will thorough and unbiased internal investigation. Establishing and regularly updating policies and procedures regarding your hotline programwill ensure employee confidence and provide investigators with guidelines on how to properly investigate reports.
