Internal Audits for Laboratories

We Help Laboratories Conduct Comprehensive Internal Audits to Assess Compliance and Identify Risks

For laboratories, maintaining compliance is a critical aspect of risk management. But, effectively managing risk extends far beyond compliance, and lab owners and executives need to know when their facilities’ operations are creating undue liability exposure.

In order to assess compliance and identify risks, laboratories must conduct internal audits on a routine basis. Labs must also conduct targeted internal audits when specific liability concerns arise. As former Department of Health and Human Services (DHHS), Federal Bureau of Investigation (FBI), and Internal Revenue Service (IRS) agents, our senior laboratory consultants are intimately familiar with the risks laboratories face on a day-to-day basis, and we offer strategic, efficient, and comprehensive internal audit services backed by extensive federal investigative experience.

Put our highly experienced team on your side

Roger Bach
Roger Bach

Former Special Agent
(DOJ-OIG & DEA)

Timothy E. Allen
Timothy E. Allen

Former Senior Special Agent
(U.S. Secret Service & DOJ-OIG)

Chris Quick
Chris Quick

Former Special Agent
(FBI & IRS-CI)

Maura Kelley
Maura Kelley

Former Special Agent
(FBI)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent
(FBI)

Michael Koslow
Michael Koslow

Former Supervisory Special Agent
(DOD-OIG)

Marquis D. Pickett
Marquis D. Pickett

Special Agent
U.S. Secret Service (ret.)

Dennis A. Wichern
Dennis A. Wichern

Former Special Agent-in-Charge
(DEA)

Routine Laboratory Compliance Audits

Perhaps the most-persistent liability risk that laboratories face is the risk of facing health care billing fraud allegations. Like all entities in the health care sector, laboratories are subject to stringent billing rules and regulations, and these rules and regulations are stringently enforced by both federal authorities and private payors.

In addition to implementing effective compliance policies and procedures, laboratories must monitor the efficacy of their compliance efforts on an ongoing basis. The means for doing so is conducting routine laboratory compliance audits. With investigative experience specifically within the health care sector, our former federal agents are able to efficiently help laboratories fully assess their compliance risk and determine when compliance program updates, re-trainings, and other responsive measures are necessary.

Internal Audits Triggered By Liability Risks

When potential exposure events arise, laboratory owners and executives need to know both the likelihood of facing liability and the amount of liability that is at stake. Both of these are key pieces of information for determining the best path forward. In order to gather this information, it is necessary to conduct a targeted internal audit focused on the specific issue(s) at hand.

There are various circumstances in which it will be prudent for laboratories to conduct targeted internal audits. For example, some of the specific issues that can trigger significant liability exposure for laboratories include:

  • Improper billings for tests or other laboratory services
  • Other compliance failures
  • Cybersecurity breaches
  • Contract and intellectual property (IP) disputes
  • Patient and employee complaints

If your laboratory faces any of these types of allegations – or any other allegation that has the potential to lead to civil litigation or federal enforcement action – it will be crucial to conduct an internal audit in order to gain a clear understanding of the facts at hand and identify the defenses your laboratory can assert to avoid or mitigate liability.

FAQs: How, When and Why Laboratories Should Conduct Internal Audits

Q: What are the steps involved in conducting an internal laboratory audit?

 

Conducting an internal laboratory audit begins with determining both the purpose and scope of the audit. Are you seeking to conduct a routine compliance audit? Or, is there a specific concern that needs to be analyzed and addressed?

Once the purpose and scope have been determined, then a strategy can be developed to efficiently gather relevant data from all available sources. This step is crucial, as overlooking even a single data source can thwart the audit’s efficacy. Finally, the audit itself can be conducted. This can involve various processes, procedures, and protocols depending on the nature of the data and the format in which the data are stored.

Q: How frequently should laboratories audit their compliance programs?

 

We typically recommend that laboratories audit their compliance programs at least annually; however, in many circumstances, it will be prudent to audit compliance more frequently. This is particularly true, for example, for new laboratories and for those that have struggled with compliance in the past. Once we examine your laboratory’s risks and needs, we can recommend a suitable internal compliance auditing schedule.

Q: What types of events can trigger the need for a targeted internal laboratory audit?

 

Several different types of events can trigger the need for a targeted internal laboratory audit. In addition to conducting routine compliance audits, laboratories should typically also conduct internal audits when faced with:

  • Medicare, Medicaid, Tricare, and DOL billing compliance audits
  • Private health insurance billing compliance audits
  • Federal health care billing fraud investigations
  • Employee allegations of harassment or discrimination
  • Employee allegations of corporate wrongdoing

The purpose of these targeted audits is to allow the laboratory’s owners and executives to make informed decisions about how to respond. Knowing what, if anything, will be uncovered during an investigation or in discovery is crucial to managing risk effectively.

Q: Should my laboratory engage an outside consulting firm to conduct or oversee its internal audits?

 

Yes, when conducting internal audits, it is essential for laboratories to engage outside consultants who have relevant expertise. This includes expertise in both (i) internal auditing processes and procedures, and (ii) the substantive issues that need to be examined. Engaging an outside consulting firm ensures not only that your laboratory’s internal audits will be conducted as efficiently as possible, but that they will uncover all pertinent information as well.

Q: What factors should laboratory owners and executives consider when choosing an outside consulting firm for internal auditing?

 

There are several factors to consider when choosing an outside consulting firm for internal auditing. However, perhaps the single most-important factor is the experience of the firm’s consultants and specialists. At Corporate Investigation Consulting, our former DHHS, FBI, and IRS agents have decades of relevant experience—including not only experience conducting internal audits for laboratories and other health care entities, but investigating allegations of health care fraud and other offenses for the federal government as well.

 

Schedule an Appointment with a Senior Laboratory Consultant Today

If you own, operate, or manage a laboratory and would like to learn more about our internal audit consulting services, we invite you to schedule a complimentary consultation. Please call 866-352-9324 or tell us how we can contact you online to speak with one of our senior laboratory consultants today.

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