Clinical Laboratory Improvement Amendments (CLIA)

Last Updated: June 30, 2018

Definition - What does Clinical Laboratory Improvement Amendments (CLIA) mean?

The clinical laboratory improvement amendments (CLIA) are a set of codes in a federal mandate passed in 1988 that covers benchmark methods associated with collecting, analyzing, and interpreting human specimen results for medical examination purposes. CLIA was introduced to guarantee that all laboratories and healthcare facilities that contribute to CLIA funded programs comply with current policies and practices in maintaining quality patient care and confidentiality. The Department of Health and Human Services (DHHS) has direct authority in granting certification approval to laboratories and all related healthcare providers. DHHS devolves administrative roles to three federal agencies including the Center for Disease Control and Prevention (CDC), Center for Medicare and Medicaid Services (CMS), and Food and Drug Administration (FDA).

WorkplaceTesting explains Clinical Laboratory Improvement Amendments (CLIA)

From the beginning, CLIA-based sponsors including clinics, laboratories, hospitals, outpatient offices, and private practice doctors have contributed to the upside of delivering accurate, effective, and reliable testing policies and procedures. Individuals and/or organizations affiliated with CLIA-based programs are required to complete an application, submit fees, pass survey requirements, and maintain CLIA code of standards.

CLIA certification generally reflects testing methods performed by different institutions based on variable factors including moderate/high laboratory complexity procedures, annual patient visits, and the nature of testing. Depending on testing requirements, laboratories garner their credentials following mandatory field surveys by a CMS agency representative who evaluates current medical testing standards are upheld. Laboratories and relevant healthcare organizations can apply for a number of certificate privileges covering an assortment of testing measures. There are five subclasses of certificates recognized by CLIA including Certificate of Waiver (CW), Certificate for Provider-Performed Microscopy Procedures (PPMP), Certificate of Registration (COR), Certificate of Compliance (COC), and Certificate of Accreditation (COA).

In addition, laboratory facilities that conduct moderate to high complexity methodologies must adhere to proficiency testing (PT) regulations to ensure pivotal aspects of medicine are observed. These include employing current technical applications and/or equipment, delivery of optimal patient care, and releasing laboratory test results to patients and/or designee per CLIA rules aligned with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

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