Some examples of items consistently cited by laboratory inspectors for Proficiency Testing deficiencies include:
- Incomplete or not Comprehensive Proficiency Testing Program -- Registration and completion of proficiency testing for all regulated analytes are required. Unregulated analytes should be assessed utilizing an appropriate process for good laboratory practice. The testing and documentation procedure should be included in the laboratory's policy and procedure.
- Alternate Proficiency Testing not Established -- Analytes or systems for which proficiency testing is not available must have an alternative proficiency testing system in place twice per year. One example of an alternative assessment process is split sample testing. The testing and documentation procedure should be included in the laboratory's policy and procedure.
- Incomplete Records -- Missing or incomplete proficiency testing records, as required for compliance, often results in citations during surveys.
- Attestation Statements -- Missing or unsigned attestation statements as required for compliance.
- Not treating/evaluating samples as patient samples -- Testing personnel must treat proficiency testing samples in the same manner as patients. Citations issued may include running samples multiple times when not indicated by established policy and procedure
- One person running all the samples -- CLIA requires that proficiency testing be rotated among all testing personnel. When rotation does not occur throughout the events, a citation will be issued
- No review or inappropriate corrective action -- Evaluation of all scored events is required. Assessment of all scores of 80% or less, codes, and events ungraded or not evaluated due to lack of consensus is required, and the evaluation is documented.
