March 7, 2023

Keeping your Practice CLIA Certified

With the latest rules and regulations, practices must stay up to date with regulatory requirements to ensure quality patient care,…

With the latest rules and regulations, practices must stay up to date with regulatory requirements to ensure quality patient care, financial gain, improved outcomes, and protection against fines and penalties.

In 1998, Clinical Laboratory Improvement Amendments (CLIA) was passed by Congress, establishing quality standards for all laboratory testing to ensure that patient test results are accurate, reliable, and efficient – regardless of where the test was performed.

The importance of compliance

If you perform point-of-care testing, you’ll have a CLIA certificate for either non-waived or waived testing. This means that your laboratory can be inspected by CMS/CLIA (generally by state inspectors) or by an accrediting organization (AO) that has been granted deeming authority by CMS.

A laboratory inspection brings anxiety and stress, especially with an inspector on site and disrupting your normal work day. While connectivity can’t help you avoid all the reasons, it can certainly help you avoid some of the biggest and most common and better prepare you.

For non-waived testing sites, CLIA follows a biennial inspection schedule. And you won’t necessarily be given notice in advance, an inspector can just arrive at any time.

Although not routinely done, CMS will also inspect waived testing sites under certain circumstances, such as if a complaint has been filed. However, it is increasingly common for waived sites to be randomly inspected, under the guise of “education” visits. If these find you noncompliant, then the same processes, policies and potential sanctions will apply.

One of the top 10 reasons why practices can be found deficient in a CLIA inspection is missing test reports or a test report not being complete.

Achieve Compliance with Relaymed

Device connectivity ensures that every test run will be complete and recorded in the EHR. Every test run is also logged in Relaymed, available for instant reporting. The inspector can request results from the past two years, or from the date of your last inspection.

What’s more, all quality control (QC) runs are also recorded, avoiding any use or reliance on paper logs. QC logs are one of the main records the inspector will request. This can help with your quality assessment (QA) plan. A lack of a QA plan is a second reason in the top 10 for compliance deficiencies.

While the regulations are there to ensure quality and best practice, there can be financial costs associated. The cost of not ensuring compliance with CLIA should be easy for your practice to quantify as it could result in CLIA certificate revocation resulting in loss of reimbursement, or worse, a requirement to cease operations until compliance is achieved.

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Further Reading

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