How to Carry Out a Compliance Investigation

Richard P. Kusserow | February 2015

Compliance officers are responsible for conducting investigations as the result of hotline reports. But the fact is, conducting a full investigation of a potential violation of law, regulations or policy is infrequent.  In many cases, this leads to avoidable mistakes that may compromise the investigation and, in some, instances aggravate circumstances.

Hardly a week goes by without a problem, arising from these mistakes, is brought to my attention and a request to find remediation to the resulting problems. This happens so frequently, I decided to provide some tips for those who conduct investigations.

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Tips for Managing a Compliance Investigation

1. Fully Debrief Complaints Promptly

Serious issues can be mishandled by allowing too much time between the filing of a complaint and debriefing the complainant. Memories fade, get distorted or get influenced by subsequent events. Any identified complainants should to be fully debriefed quickly, as to the basis of their allegations, concerns, and complaints; and any supporting evidence to the allegations should be gathered promptly.

2. Need to Know Guiding Rule

The general rule for all investigations should be under the “need to know” standard. This means that all discussions regarding the investigation should be restricted to only those that need to know. Under this guiding principle there should be no sharing of information regarding the predication, direction, or findings of the process with any unauthorized parties.

3. Remain Independence and Objective

The process of conducting the investigation must be viewed as an independent inquiry free of outside influence. There must be a fair and impartial review of all relevant facts.

4. Include Management’s Perspective

Often complaints and allegations are made about management’s decisions and actions. It is important to include management’s views as part of the report and not rely solely upon representations of staff.

5. Exercise Discretion

It is imperative that the compliance officer be discreet when gathering pertinent facts and evidence. Particularly in a confined work environment where the workplace “grapevine” moves faster than the investigation. This “chatter” can undermine the effort in effective interviews with individuals. Therefore, exercise discretion when selecting sites for interviews to avoid overhearing or conjecture as to what is happening.

6. Avoid Using Original Documents

All original documents that are evidentiary to the case should be tagged, logged, and placed in a secure file. All interviews where such documents are relevant to the process should be with copies, not original documents.

7. Control and Track All Cases

All hotline reports from complainants or otherwise should be date-stamped, logged, and numbered as part of the Compliance Office’s records management policy. Document Control. All records of investigation should be kept under lock and key control in a limited access area. Having information about an active or past investigation go astray can create a huge problem and potential liability. All too often, documents are left accessible or in plain view. Losing control over evidence, documents, or notes of interviews can be a serious issue.

8. Follow a Chain of Custody

All evidence obtained during an investigation must be tracked and never outside the control of the investigators. This is referred to as maintaining “chain of custody” and failure to do this may result in the evidence being questioned or disallowed in a formal adjudicative process.

9. Stay Focused but 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 be distracted by extraneous information. It is critical to stay focused, but not to the point of being inflexible. Many times, the investigation will have to adapt to changing fact patterns or conditions. This is not meant to conflict with the previous point, but to recognize that under certain circumstances that 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 related problems to the original complaint or allegation.

10. Be Comprehensive and Detailed.

There is only one chance when it comes to investigations. Therefore, it is critical that everything is 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.

11. Work to Prevent Retaliation.

The worst outcome of any investigation is one that results in retaliation or retribution against the original complainant or witnesses. This issue is specifically addressed in the HHS Office of Inspector General’s multiple compliance program guidance documents. Retaliatory actions can lead to serious legal liability.

If your organization has frequent investigations consider having a training program on the proper methods of conducting an investigation. It is advisable to have all those who may be called upon to conduct an investigation to be included in the program. These may not be limited to the Compliance Office. Many others may get involved in such activities from Human Resources, Security, Internal Audit, Legal Counsel, etc.

About the Author

Richard P. Kusserow established Strategic Management Services, LLC, after retiring from being the DHHS Inspector General, and has assisted over 3,000 health care organizations and entities in developing, implementing and assessing compliance programs.