These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance.
    Author: Westgard JO, Westgard SA.
    Journal: Am J Clin Pathol; 2006 Mar; 125(3):343-54. PubMed ID: 16613337.
    Abstract:
    To assess the analytic quality of laboratory testing in the United States, we obtained proficiency testing survey results from several national programs that comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. We studied regulated tests (cholesterol, glucose, calcium, fibrinogen, and prothrombin time) and nonregulated tests (international normalized ratio [INR], glycohemoglobin, and prostate-specific antigen [PSA]). Quality was assessed on the sigma scale with a benchmark for minimum process performance of 3 sigma and a goal for world-class quality of 6 sigma. Based on the CLIA criteria for acceptable performance in proficiency testing (allowable total errors [TEa]), the national quality of cholesterol testing (TEa = 10%) estimated sigma values as 2.9 to 3.0; glucose (TEa = 10%), 2.9 to 3.3; calcium (TEa = 1.0 mg/dL), 2.8 to 3.0; prothrombin time (TEa = 15%), 1.8; INR (TEa = 20%), 2.4 to 3.5; fibrinogen (TEa = 20%), 1.8 to 3.2; glycohemoglobin (TEa = 10%), 1.9 to 2.6; and PSA (TEa = 10%), 1.2 to 1.8. The analytic quality of laboratory tests requires improvement in measurement performance and more intensive quality control monitoring than the CLIA minimum of 2 levels per day.
    [Abstract] [Full Text] [Related] [New Search]