CLIA Certification: Questions Answered & Concepts Explained

At Countrywide Testing, we often receive questions about what CLIA certification is and what it might mean for business owners. Since lab drug testing and associated standards are of great importance to human resources management, legal cases, and workplace safety, we consider this information to be of the utmost importance. We take your questions seriously, and hope to resolve the most common areas of confusion in one easy to access place: this blog post. Read on to learn all you need to know about CLIA accreditation, and how it applies to your practice. 

Please note that the examples used in answering these questions are suited to a physician’s office or a medium sized medical practice with an attached lab.

 What is CLIA certification?

CLIA means Clinical Laboratory Improvement Amendments. These are a set of standards administered by three government agencies. These agencies are the CMS, or Center for Medicaid and Medicare Services, The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC).

CLIA are a set of standards administered state by state. A CLIA Lab is required to be certified according to CLIA standards before it can accept samples for diagnostic testing. Labs can obtain multiple CLIA certificates, based on the diagnostic tests that they carry out.

Even small doctor’s offices that only conduct routine tests such as glucose sticks and urine dips will need to apply for at least a certificate of waiver, which is detailed below. For the purposes of the law, even a doctor’s office can count as a lab, if any sort of testing is done. 

What is required to become a CLIA certified lab?

Normally, a lab fills out a government form CMS-116 and joins the CLIA program through their state office. This is important for physician offices who conduct routine tests such as glucose blood tests or urine strips. Despite the in-person and office-based nature of these tests, even small-scale testing such as these counts as lab testing. These are called waived tests.  The rules are different in New York and Washington State since these states run their own lab testing programs. Contact your local CLIA state office for details. More details on CLIA waived tests and CLIA laboratory programs can be found here.

Different kinds of CLIA certificates, explained

There are four different kinds of CLIA certificates:

Certificate of Waiver

As described before, Certificate of Waiver is for performed since-procedure waived tests in the physician’s office. These includes things like urine dip testing and blood glucose level testing. Certificate of Waiver is ideal for most physician practices.

Provider Performed Microscopy

This certificate allows a provider to perform a range of moderate complexity tests, as well as all waived tests, usually using a microscope. This is an ideal accreditation for medical practices that have attached labs or testing facilities.

CLIA Certificate of Registration

This certificate is issued to a laboratory to conduct medium complexity tests and all waived tests until the lab entity is determined to comply via inspection and survey with CLIA requirements. Such surveys are carried out by state offices of the CMS, so we recommend contacting your state office for details.

CLIA Certificate of Compliance

This certificate is issued after a government inspection that finds the lab to be compliant with all CLIA requirements. This is usually conducted in conjunction with qualifying with a certificate of accreditation from a CMS approved organization.

Certificate of Accreditation

The Certificate of Accreditation is issued by an organization approved by the CMS, based on the organization’s standards. There are several organizations that are approved by the CMS. These include:

• American Association of Blood Banks
• American Osteopathic Association
• American Society of Histocompatibility and Immunogenetics
• Commission on Office Laboratory Accreditation
• College of American Pathologists 
• Joint Commission on Accreditation of Healthcare Organizations

These six organizations have been approved by the CMS and all have a compliant CLIA laboratory program.

Are there exceptions?

Exceptions for CLIA certification apply only in Washington State and New York State, as these states have their own CMS approved lab testing programs. All labs in other states must apply to the CLIA testing programs. It’s also important to note that application to CMS approved accreditation programs must take place at the same time a lab applies for CLIA accreditation. Contact your state CLIA office for further details.

Countrywide Testing

If you need a certificate of waiver or a PPM certificate for your medical office, then Countrywide Testing can help. We work with CLIA certified testing partners, and can help you through the entire application process. We also provide the necessary guidance in helping you fulfill the requirements for a certificate of waiver or PPM certificate, depending on your facility’s needs.

Still have questions? Contact us today to discuss your office’s needs. As experts in the testing field, we’re more than happy to help you serve your patients with the highest level of care.