Norris Cunningham

In the first part of this series, we discussed drug diversion: what it is, how to prevent it and how to spot it.  This column will focus on how to conduct drug diversion investigations.  

When drug diversion is suspected or has been reported at your facility, you must move quickly and decisively to conduct a detailed and thorough investigation.  Crucially,  facilities must be careful to fulfill all local, state and federal reporting obligations.  

The internal investigation

It is imperative to conduct a detailed and thorough investigation to report suspected diversion because incomplete investigations and follow-up can have serious patient care, legal and compliance implications.  Although facility leadership and area supervisors where diversion is suspected will assist in conducting the investigation, outside legal counsel should be involved to ensure that biases do not influence the investigation.

Steps of a proper investigation

First, determine whether the diversion is isolated or significant.  Any unresolved discrepancy should be considered a possible diversion and escalated to being investigated.  If it is significant, a root cause analysis and recommendations approach should be undertaken to prevent future diversions. 

Next, create a standardized process for interviewing suspected controlled substance diverters.  Erring on the side of caution, suspension of possible diverters should be undertaken, and revocation of their login credentials for the electronic medical record as well as the automated dispensing unit must occur as soon as possible. Develop questions to reveal the diverter’s drug of choice, when it started, his/her method(s) of diversion, the location(s) the diversion took place, what records were/were not kept and an estimated amount of the drug loss. 

Angela Rinehart

In addition to interviewing the suspected diverter, a standardized process for interviewing patients potentially affected by the diversion should be conducted as well.  Further, a defined process for internal and external reporting of medication diversion incidents is necessary.

Then, the facility should conduct a systems analysis of controlled substance processes including failure modes and effects to identify risk points to take action to improve diversion prevention.  Collect key documents necessary to conduct a thorough investigation and create separate files for the investigation and quality assurance.

Review records for the suspected diverter(s) to determine whether drug counts reveal a loss or if the drugs were administered without approved orders.  Confirm via a thorough audit conducted either by outside legal counsel or the Control Substance Diversion Prevention Program Director that diversion by facility leadership (director of nursing, unit manager, etc.) has not taken place.  Confirm that drug testing has taken place and the result and create a final report of the diversion incident.

The regulatory investigation

In addition to the internal investigation of suspected diversion, a regulatory investigation is inevitable.  As such, facilities should be prepared for the typical documents and information requested by regulatory agencies when drug diversion occurs.  

Regulatory authorities will want to know the date(s) of each diversion, identification of residents whose medications were diverted, the medication diverted, amount of medication diverted and the monetary value of each medication diverted.  In addition, any medications paid for by Medicare or Medicaid could have implications for overpayments under applicable payment rules and statutes.  Facilities will want to discuss these issues thoroughly with legal counsel. Regulatory authorities will also want to know whether surveillance video is available, how long video is available before the system overwrites, and whether the surveillance video is monitored.  It is advisable that facilities put all surveillance video and documentation on a legal hold as soon as any diversion incident is suspected.

John Myers

As for documentation, authorities will typically request the medical chart, or electronic health record of the resident(s) involved including, but not limited to, admission records/facesheets, physician orders for the medication/order summaries, medication administration records/eMARs during the period of the suspected diversion, controlled substance accountability sheets, drug disposal logs/medication disposition sheets, nurses’ notes, pain and pain symptoms risk care plans, pain evaluation UDAs/pain monitoring tools/pain evaluation forms, resident behavior logs and resident mood for MDS. 

‘The investigation file, including the Department of Health incident report, staff interviews and statements, a timeline of events, verification of investigation/risk report, resident interviews and summary report of meetings/in-service, will also be requested.

In sum, when diversion is suspected investigations need to be conducted as thoroughly and completely as possible and reporting needs to occur in accordance with laws and regulations.  Having standardized processes in place will make diversion investigations easier to navigate.

Norris Cunningham is a founding shareholder and leads the Health Care Practice Group at Katz Korin Cunningham PC (KKC) in Indianapolis. Contact him at [email protected]

Angela Rinehart is an associate attorney in the Health Care Practice Group at KKC and focuses her practice on the defense of long-term care providers. Contact her at [email protected].

John Myers is the litigation support director for KKC and has extensive trial and technical support experience for all aspects of litigation. Contact him at [email protected].

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.