Laboratory precision performance: state of the art versus operating specifications that assure the analytical quality required by clinical laboratory improvement amendments proficiency testing. 1996

J O Westgard, and N Bawa, and J W Ross, and N S Lawson
Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison, USA.

OBJECTIVE To estimate the percent of laboratories with precision performance sufficient to satisfy the operating specifications and guarantee the quality required by the proficiency testing criteria defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). METHODS Cumulative distributions that describe state-of-the-art laboratory imprecision were obtained for 1500 laboratories participating in the 1990 College of American Pathologists Quality Assurance Service. Allowable imprecision was estimated from the x-intercepts of charts of operating specifications prepared for commonly used single and multirule quality control procedures having two to four control measurements per run. METHODS The derived values for allowable imprecision were imposed on the cumulative distributions to obtain graphical estimates of the percent of laboratories satisfying the operating specifications. RESULTS Up to 28% of laboratories achieve the imprecision allowable for albumin, up to 64% for total bilirubin, 52% for calcium, 35% for chloride, 48% for cholesterol, 28% for cortisol, 84% for creatinine, 9% for digoxin, 61% for glucose, 64% for high-density lipoprotein cholesterol, 88% for hemoglobin, 95% for potassium, 66% for total protein, 18% for sodium, 29% for thyroxine, 87% for triglycerides, 35% for urea nitrogen, and 81% for uric acid. CONCLUSIONS Improvements in precision are still needed for many laboratory tests to assure the analytical quality required by the CLIA proficiency testing total error criteria.

UI MeSH Term Description Entries
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D001774 Blood Chemical Analysis An examination of chemicals in the blood. Analysis, Blood Chemical,Chemical Analysis, Blood,Analyses, Blood Chemical,Blood Chemical Analyses,Chemical Analyses, Blood
D005069 Evaluation Studies as Topic Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D005161 Facility Regulation and Control Formal voluntary or governmental procedures and standards required of hospitals and health or other facilities to improve operating efficiency, and for the protection of the consumer. Facility Control,Facility Regulation,Regulation, Facility,Control, Facility,Controls, Facility,Facility Controls,Facility Regulations,Regulations, Facility
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D019411 Clinical Laboratory Techniques Techniques used to carry out clinical investigative procedures in the diagnosis and therapy of disease. Clinical Laboratory Test,Clinical Laboratory Testing,Clinical Laboratory Diagnoses,Clinical Laboratory Testings,Clinical Laboratory Tests,Diagnoses and Laboratory Examinations,Diagnosis, Laboratory,Laboratory Diagnosis,Laboratory Examinations and Diagnoses,Laboratory Techniques, Clinical,Clinical Laboratory Technique,Diagnose, Clinical Laboratory,Laboratory Diagnoses,Laboratory Technique, Clinical,Laboratory Test, Clinical,Laboratory Testing, Clinical,Technique, Clinical Laboratory,Test, Clinical Laboratory,Testing, Clinical Laboratory

Related Publications

J O Westgard, and N Bawa, and J W Ross, and N S Lawson
March 2013, Clinics in laboratory medicine,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
November 1991, Clinical chemistry,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
February 1992, Journal of health and hospital law : a publication of the American Academy of Hospital Attorneys of the American Hospital Association,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
April 2004, Journal of the National Cancer Institute,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
November 2020, Clinica chimica acta; international journal of clinical chemistry,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
March 2023, Clinical chemistry and laboratory medicine,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
September 1996, Clinics in laboratory medicine,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
July 2017, Clinical biochemistry,
J O Westgard, and N Bawa, and J W Ross, and N S Lawson
December 2002, Archives of pathology & laboratory medicine,
Copied contents to your clipboard!