Inside perspectives on CLIA inspections

OBJECTIVE: To help laboratory directors prepare for inspections based on the Clinical Laboratory Improvement Amendments (CLIA) of 1988. DATA SOURCES: Authors' knowledge of regulations; two directors of laboratories that had undergone CLIA inspections; one CLIA inspector. DATA EXTRACTION: Interviews. DATA SYNTHESIS: Directors offer suggestions about preparing records for CLIA inspection related to personnel, continuing education, and quality control. Advice on staff department, and perspective on the inspectors' role as educators is included. CONCLUSION: Laboratories operating with good standard laboratory practices should not see their costs or procedures change much under CLIA. Inspectors would rather help laboratories reach compliance than cite them; inspectors see themselves, in part, as educators.