Achieving the Health Care Financing Administration limits by quality improvement and quality control. A real-world example.

With the enactment of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88), the federal government is now using proficiency testing as the primary indicator of laboratory quality. Laboratories with proficiency test failures are now at risk of a variety of harsh penalties including large monetary fines and suspension of operations. To minimize the risk of failed proficiency testing, we initiated a continuous quality improvement program in our general chemistry laboratory in conjunction with the use of a new survey-validated quality control product. This article describes the quality improvement program and our success in reducing the long-term random error in general chemistry. Despite our improvement program, significant analytical errors (greater than 30% of the CLIA limits) still exist in analytes measured by our chemistry analyzer. These errors are present in nearly the same analytes measured by other common chemistry analyzers indicating the need for improvement in their design and manufacture.