Charts of operational process specifications ("OPSpecs charts") for assessing the precision, accuracy, and quality control needed to satisfy proficiency testing performance criteria.
"Operational process specifications" have been derived from an analytical quality-planning model to assess the precision, accuracy, and quality control (QC) needed to satisfy Proficiency Testing (PT) criteria. These routine operating specifications are presented in the form of an "OPSpecs chart," which describes the operational limits for imprecision and inaccuracy when a desired level of quality assurance is provided by a specific QC procedure. OPSpecs charts can be used to compare the operational limits for different QC procedures and to select a QC procedure that is appropriate for the precision and accuracy of a specific measurement procedure. To select a QC procedure, one plots the inaccuracy and imprecision observed for a measurement procedure on the OPSpecs chart to define the current operating point, which is then compared with the operational limits of candidate QC procedures. Any QC procedure whose operational limits are greater than the measurement procedure's operating point will provide a known assurance, with the percent chance specified by the OPSpecs chart, that critical analytical errors will be detected. OPSpecs charts for a 10% PT criterion are presented to illustrate the selection of QC procedures for measurement procedures with different amounts of imprecision and inaccuracy. Normalized OPSpecs charts are presented to permit a more general assessment of the analytical performance required with commonly used QC procedures.
Westgard
J O
JO
Department of Pathology and Laboratory Medicine, Medical School, University of Wisconsin, Madison 53792.
D002624:Chemistry, Clinical / Q000331:legislation & jurisprudence / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards* / Q000706:statistics & numerical data; D008004:Licensure / Q000331:legislation & jurisprudence; D011786:Quality Control