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How often should competency assessment be performed? Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patient specimens. Thereafter, competency assessment must be performed at least annually.

Proficiency testing is NOT required for waived testing; however, it can be used by waived labs as an indication of accuracy of testing. Proficiency testing is required for non-waived testing; however, it is required only for regulated analytes. The regulated analytes are listed in subpart I of the regulations.

CLIA defines six elements of competency assessment for anyone who actually performs testing, and all six must be documented for each person, each year.

Yes, competency assessment for non-waived testing must include all six methods, as applicable to the test system. The six elements include: Direct observation of routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing and testing.

The laboratory director is ultimately responsible for the oversight of competency; the director authorizes specific responsibilities and duties of supervisors and consultants, and ultimately, of all staff who are involved in all phases of testing.

A typical competency assessment process Step 1 - self assessment. The first step in competency based assessment is for a person to conduct a self-assessment. ... Step 2 - assessor review. ... Step 3 - identify development needs. ... Step 4 - on and off the job learning. ... Step 5 - re-assessment.

CLIA defines six elements of competency assessment for anyone who actually performs testing, and all six must be documented for each person, each year.