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The most common and costly laboratory compliance issues

Updated: Nov 14


The Office of Inspector General (OIG), and others like the CMS, and DOJ usually target 18 areas of lab businesses the most. Many lab managers manage to overcome the inspection due to the guidance and help of a laboratory consultant. So, if your lab is selected, the investigation will most likely center on these areas of lab compliance violations. Keep reading to learn, prepare, and avoid the most common laboratory compliance issues.


1- Placing laboratory staff members in a physician’s office


It’s not uncommon for labs to place employees in a physician’s office for reasons such as collecting and processing samples for testing. Although this is not strictly illegal, it does raise bright red flags under laws. So, it’s essential to be careful when placing staff in-office to ensure they don’t cross any kickback lines.


2- Billing and coding rules


Laboratories that perform their tests under pass-through arrangements must ensure they do the proper billing and coding. One important thing to note here is that when the referring lab is billing for the referred test, it must list the CLIA number and address of the reference lab, as well as use the modifier -90. Since this tends to be tricky, working with a laboratory consultant will help you follow the correct rules and standards.


3- Requirements when hiring physicians as employees


One common compliance area inspector focus on is if the laboratory has followed the key guidelines when hiring healthcare professionals as contractors or employees. This is important since those working in a clinical laboratory are the ones responsible for conducting tests that provide crucial information for detecting, diagnosing, treating, and monitoring illnesses. Therefore, labs should meet all the requirements and know the expectations when hiring employees.


These are just some of the most common compliance issues laboratories can face if they don't follow the latest OIG, CMS, and DOJ guidelines. Beware, since the repercussions and consequences can be not only severe but also costly. The best way to be fully compliant in each of these areas is to work with a laboratory consultant. If you want to learn more contact us today and we can help you pass these common compliance issues during a laboratory inspection.

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