Limitationsof Quality Control in Physicians’Offices and Other Decentralized Testing Situations:The Challenge to Develop New Methods of Test Validation

Traditional quality-control methods are effective for de-tecting systematic error caused by deterioration of re-agents or instruments, but ineffective for detecting spo-radic error, which is more likely to occur in low-volume testing environments. Decentralized testing performed by individuals without formal laboratory training has a high potential for sporadic errors. New methods for validating test results, used each time a test result is produced, should replace current quality-control procedures. Under the rules of CLIA ‘88, manufacturers and the US Food and Drug Administration have an opportunity to develop new approaches to test validation. Quality-control (QC) testing has been used since the 1950s as a means of ensuring that the variability of laboratory test results is within allowable limits. QC, a