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The history of proficiency testing/quality control
1Institute for Clinical Science, Philadelphia, PA 19107.
Clinical Chemistry
|July 11, 1992
Summary
Proficiency testing in clinical labs, introduced in the 1940s, significantly improved lab performance. Early poor results highlighted the need for regulations like the Clinical Laboratory Improvement Act of 1967.
Area of Science:
- Clinical laboratory science
- Medical diagnostics quality assurance
Background:
- Review of the historical development and origins of clinical laboratory proficiency testing.
- Exploration of the impact of early performance data on regulatory frameworks.
Observation:
- Proficiency testing was established in the late 1940s.
- Significant improvements in clinical laboratory performance have been observed since its inception.
Findings:
- The historical poor performance of clinical laboratories was a key factor cited for the enactment of the Clinical Laboratory Improvement Act of 1967 (CLIA '67).
- Proficiency testing has demonstrably enhanced the quality and reliability of clinical laboratory results over time.
Implications:
- Highlights the crucial role of external quality assessment in maintaining high standards in diagnostic testing.
- Underscores the historical link between performance monitoring and regulatory oversight in healthcare.
- Provides context for current quality assurance practices in clinical laboratories.