Laboratory Regulatory

CLIA requirements for proficiency testing: the basics for laboratory professionals

Along with requirements for personnel qualifications and quality control testing, proficiency testing (PT) is one of the central safeguards of laboratory quality under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and its regulations. The CLIA regulations have often been compared to a three-legged stool, resting on requirements for personnel qualifications and two performance indicators: quality control testing and proficiency testing. Proficiency testing is the only external performance indicator required by CLIA. Despite its central role, PT problems continue to be cited by CLIA surveyors. Among the more serious “condition level” deficiency citations given to laboratories inspected by CMS in 2012, unsuccessful PT participation and failure to enroll in PT were, respectively, the second- and third-most common citations. For all combined types of deficiencies cited by CMS in 2012 (condition and standard levels, combined), the third-most common deficiency was failure of laboratories to verify accuracy twice per year for analytes and tests for which participation in a PT program is not specifically required in CLIA Subpart I…. (Read More Here)

CLIA requirements for proficiency testingSource of the image: MLO-Online


Top 5 Deficiencies for Laboratories

As a Quality Advisor, I spend a lot time speaking with labs that are either brand new, in the process of getting started, or laboratories that have been in operation for years. One interesting thing I find is that, regardless of whether the lab is new or has been accredited for years, there are some common areas where labs tend to have deficiencies and therefore receive citations. Here’s some insight into what I’ve designated as the Top 5 Deficiencies for Laboratories and How to Prevent Them.

Personnel: This area tends to be one of the top cited; one reason is lack of awareness about personnel requirements for the complexity of the testing being performed…

Proficiency Testing: When it comes to deficiencies in proficiency testing (PT), what I see most often is labs not treating proficiency testing samples the same as patient samples. Sometimes this can be a source of confusion for labs….

Quality Control (QC): For QC the issue encountered most often is lack of appropriate corrective action. Running a control repeatedly until it comes in does not fix the problem! …(Read More)

Transition from EQC to IQCP: What it means to Physician Office Laboratories

On January 1, 2014, the Centers for Medicare and Medicaid Services (CMS) implemented a new alternative Quality Control (QC) option for non-waived laboratory testing. CLIA laboratories can now begin to voluntarily transition away from Equivalent Quality Control (EQC) and begin using either the default CLIA Quality Control (QC) requirement, or the new option called the Individualized Quality Control Plan (IQCP). Physician Office Laboratories (POLs) will now have to determine if IQCP is the right choice for them.

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