Laboratory Compliance (CLIA)

What Are Laboratory Compliance Regulations?

Generally speaking, CLIA regulations depend on the type of tests you perform. Most physicians who test human samples in the office have a Certificate of Waiver (CoW). With a CoW, healthcare staff can only perform waived tests. Examples of waived tests can include a simple urinalysis or urine pregnancy test. Office staff must follow the manufacturer’s instructions for performing, handling and storing these tests, among other requirements.

While CMS will not routinely inspect your laboratory if you have a CoW, they can still conduct an inspection at any time. In addition, CMS may survey your laboratory if a complaint is filed or if they suspect you’re performing non-waived tests. While operating a laboratory, the office will be required to meet all the regulations referenced in Subpart A of the Code of Federal Regulations if you perform tests of moderate complexity and have a Certificate of Compliance (CoC) or Certificate of Accreditation (CoA).

Laboratories with a CoC or CoA are inspected every two years to ensure compliance. However, we encourage all laboratories to be “inspection ready” in order to prevent potential certification or reimbursement issues.

You can find the general inspection requirements in Subpart Q of the Code of Federal Regulations. As you’ll see, an inspector will do the following during a survey:

• Observe staff performing procedures and examining samples
• Interview personnel, asking questions about compliance regulations
• Access any area in the lab, including processing, storage and testing spaces
• Ask for copies of all laboratory records or data

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