Our Former Federal Agents Provide Compliance and Other Consulting Services to Laboratories Nationwide
Laboratory Consulting Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Laboratories in the United States face substantial compliance burdens. From managing Medicare and Medicaid billing compliance to ensuring that all tests are performed within the confines of FDA approval, virtually all aspects of laboratories’ operations are subject to scrutiny at the federal level.
But, of course, compliance is not laboratories’ only concern. From cybersecurity threats to litigation risks, laboratory owners and executives face numerous other day-to-day concerns as well. In order to make informed decisions and protect their labs, owners and executives must rely on the advice of experienced professionals.
Comprehensive Consulting Services for Toxicology Laboratories
At Corporate Investigation Consulting, we provide comprehensive consulting services to toxicology laboratories throughout the United States. Our consultants and specialists have prior experience working for the U.S. Department of Health and Human Services (DHHS), Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Internal Revenue Service (IRS), and other federal agencies. As a result, we have a comprehensive understanding of laboratories’ obligations at the federal level, and we are intimately familiar with the complex practices and procedures involved in government health care fraud audits and investigations.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
We assist toxicology laboratory owners and executives with all aspects of compliance, risk management, auditing, and litigation defense. Our services include:
Compliance Consulting
Do you have questions or concerns about your laboratory’s current compliance program? We can assess the sufficiency of your lab’s current program and determine where additional efforts are necessary. We can assist with the development of appropriate and custom-tailored policies and procedures, and we can provide guidance with regard to all aspects of compliance implementation.
Internal Audits
We conduct internal audits and provide audit consulting for toxicology laboratories focused on all areas of compliance. In addition to matters that are health care-specific, this includes matters such as employment and cybersecurity law compliance. We provide internal audit services both on a routine basis and on an as-needed basis when issues (or potential issues) arise.
External Audit Defense
With our consultants’ and specialists’ federal law enforcement backgrounds, we bring unique insights to assisting laboratories with external audit defense. We have deep experience on both sides of external audits examining labs’ Medicare, Medicaid, DEA, and FDA compliance efforts—among other matters. This includes audits conducted by federal agencies as well as audits conducted by Medicare contractors (i.e. MACs, RACs, and UPICs) and private insurers.
Cybersecurity Consulting & Internal Audits
Laboratories have extensive cybersecurity obligations, as they must implement appropriate protections to ensure the integrity of their patients’ and employees’ personal information. We consult with laboratories regarding their cybersecurity needs, and we assist with cybersecurity implementation, penetration testing, and internal auditing as well.
Digital Forensics Consulting
We work with forensic toxicology laboratories to further enhance their offerings to their clients, and we conduct digital forensics on behalf of laboratories facing audits, investigations, and lawsuits as well. Our digital forensics specialists hold numerous certifications and rely on decades of experience in both the public and private sectors.
Risk Management Consulting
Effective risk management is crucial to maintaining the profitability of any laboratory. We work with lab owners and executives to identify and assess their risks, and then we develop and implement custom-tailored risk management strategies that are suited to their particular risk tolerances and needs.
FAQs: Laboratory Compliance, Cybersecurity, Audits, Digital Forensics, and Risk Management
Q: Why is it important for toxicology labs to adopt comprehensive compliance programs?
Laboratories face heavy compliance burdens, and they are subject to the oversight of numerous federal agencies. This makes it critically important for lab owners and executives not only to prioritize compliance, but to ensure that their compliance policies and procedures comprehensively address all potential risks. Even minor oversights can lead to fines, recoupments, and other penalties, and laboratories with a history of compliance failures are more likely to face external audits on an ongoing basis.
Q: What is involved in effectively implementing a laboratory compliance program?
Adopting suitable policies and procedures is just the first step toward establishing compliance. The next step is compliance program implementation. This involves disseminating the lab’s policies and procedures to all personnel, providing training that is tailored to individual employees’ roles, and conducting periodic internal audits to determine whether additional compliance measures are necessary.
Q: When should toxicology laboratories conduct internal audits?
Toxicology laboratories should conduct periodic internal audits to assess compliance. These audits should take place at least annually, but it may make sense to audit more frequently under certain circumstances (i.e. if additional compliance measures have recently been implemented in order to address past systemic compliance failures). Labs should also conduct internal audits when facing external audits or potential litigation.
Q: What should I do if my lab is being audited by a federal agency or insurance company?
If your lab is being audited by a federal agency or insurance company, you should engage an outside consulting firm such as Corporate Investigation Consulting to oversee the audit process. When you choose Corporate Investigation Consulting, our consultants and specialists will intervene in the audit, identify the issue(s) that are under scrutiny, and conduct an internal assessment in order to judge your lab’s level of risk in the inquiry. With this information in hand, we can then develop an audit defense strategy and work to steer the external audit toward a favorable outcome.
Q: What cybersecurity measures are necessary for toxicology laboratories?
In today’s world, toxicology laboratories must implement several cybersecurity measures in order to protect their patients’ and employees’ personal information. We help labs develop comprehensive cybersecurity programs, including everything from access controls to firewalls, and from anti-malware applications to periodic penetration testing. As a result of our experience working with laboratories, we have a clear understanding of labs’ cybersecurity needs, and we can develop and implement a program that is custom-tailored to your lab’s operations, sensitive data, and budget.
Learn More about Our Laboratory Consulting Services
For more information about our consulting services for laboratories, please contact us today. Call 866-352-9324 or request an appointment online to speak with one of our former federal agents in confidence.