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3 things diagnostic labs need to know about regulatory compliance

Laws and regulations are present to better ensure diagnostic labs provide quality care. A failure to abide by these regulations can result in serious penalties. There are many government agencies that oversee these regulations. The United States Department of Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are a few of the more prominent federal agencies that diagnostic labs may encounter.

These federal agencies will monitor labs for compliance. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) outline the rules that are required for compliance. In addition to outlining rules for quality lab testing, this law also requires labs to receive certification from their state and the CMS before it can test human samples.

What type of compliance are these agencies looking for?

Things that federal agencies will look for when monitoring labs for compliance include:

  • Billing practices. CMS officials will monitor billing practices. Diagnostic labs are wise to only bill for medically necessary diagnosis or treatments. Billing to CMS for tests that are used for screening purposes are often denied. There are a few exceptions. Know these exceptions and make sure your billing team codes things appropriately.
  • Lab practices. The FDA will monitor the types of tests and equipment used by the lab. A failure to use approved tests, instruments or equipment can result in allegations of non-compliance.
  • Improvement. The CDC expects labs to continue to improve, to stay current on information that will impact their practices.

The diagnostic lab leadership team can take proactive steps to reduce the risk of allegations of non-compliance. Designating a compliance program leader and conducting regular internal audits are two ways to mitigate this risk.