CLIA
How should I prepare for a CLIA inspection?
CLIA inspections are performed every two years if you are in a moderate- or high-complexity lab. The top 10 deficiencies found in CLIA inspections among all labs over the past several years have been:
Director qualifications
Test reports missing
General systems/written policies incomplete
Director not following quality assessment program
Expired reagents
Incomplete procedure manuals
No formal quality assessment program
Not maintaining equipment
Lack of proficiency testing
Poor storage of reagents
Ensure that your laboratory is following the proper procedures in these areas and provide your inspector with the proper documents in an organized manner ahead of time. The more organized you are, the easier it is for the inspector to evaluate your documents and complete the assessment.
Common CLIA deficiencies found in a dermatology practice
One of the most common concerns being noted recently by CLIA inspectors has been the lack of formal personnel requirements for Mohs technicians. CLIA requires that anyone performing a high-complexity test such as Mohs surgery must possess at least an associate degree in laboratory science or medical laboratory technology, or at least 60 semester hours of higher education, including at least 24 semester hours that are science-based. If your practice has a medical assistant or histotechnologist grossing tissue or performing any high-complexity testing, they are required to meet those educational requirements.
Another common concern is the lack of proper quality control with procedures. Dermatology practices should test a minimum of two controls on each day patient samples are tested for proper quality control. Additionally, if a control is unavailable, the practice can split samples for testing with another CLIA-certified laboratory. There are exceptions to this depending on the type of test being performed.
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