Understanding CLIA certification: General requirements

In previous posts, we have looked at the various levels of CLIA certification; certificates of waiver, Provider performed microscopy, Registration, Compliance and Accreditation.  We have briefly looked at what each means and the requirements associated with each one.

Now, starting with 42 CFR § 493.551 we will look at general requirements for laboratories.

A laboratory may opt to be accredited by a private non-profit accrediting organization, or in some states with a laboratory licensing program established by law, be exempted from CLIA program requirements. Currently, New York and Washington are the only 2 states with CLIA exemptions However, for this to be the case, several conditions must be met:

·        The requirements of the alternative program or organization must be as strict or stricter than the CLIA condition-level requirements.

·        The alternative program or organization must be approved by CMS.

·        The laboratory must authorize release of records and information to CMS by the program or organization.

Examples of private accrediting organizations include the College of American Pathologists (CAP), the Commission on Laboratory Accreditation (COLA) and the Joint Commission (TJC). A laboratory that is accredited under these provisions must still obtain a certificate of accreditation from CMS, pay the applicable fees and meet the Proficiency Testing (PT) requirements of CMS which include release of all PT data to the accrediting organization and to CMS.

Subpart E which includes 42 CFR § 493.551 through 42 CFR § 493.575 delineates the relationship and requirements between CMS and State licensing programs or private accrediting organizations. The biggest takeaway from these sections for laboratories is that as an ongoing evaluation of state level licensing programs and private non-profit accrediting organizations, CMS retains the right to conduct inspections of accredited laboratories and laboratories must comply with these inspections or face suspension, revocation or limitation of its CLIA certification. These inspections are outside of the required biennial inspections for accreditation performed by the accrediting agency.

Requirements for laboratory accreditation can seem daunting. A laboratory consultant can help navigate these complex requirements