A model for the statistical description of analytical errors occurring in clinical chemical laboratories with time

The main purpose of the present study was to describe the statistical behaviour of daily analytical errors in the dimensions of place and time, providing a statistical basis for realistic estimates of the analytical error, and hence allowing the importance of the error and the relative contributions of its different sources to be re-evaluated. The observation material consists of creatinine and glucose results for control sera measured in daily routine quality control in five laboratories for a period of one year. The observation data were processed and computed by means of an automated data processing system. Graphic representations of time series of daily observations, as well as their means and dispersion limits when grouped over various time intervals, were investigated. For partition of the total variation several two-way analyses of variance were done with laboratory and various time classifications as factors. Pooled sets of observations were tested for normality of distribution and for consistency of variances, and the distribution characteristics of error variation in different categories of place and time were compared. Errors were found from the time series to vary typically between days. Due to irregular fluctuations in general and particular seasonal effects in creatinine, stable estimates of means or of dispersions for errors in individual laboratories could not be easily obtained over short periods of time but only from data sets pooled over long intervals (preferably at least one year). Pooled estimates of proportions of intralaboratory variation were relatively low (less than 33%) when the variation was pooled within days. However, when the variation was pooled over longer intervals this proportion increased considerably, even to a maximum of 89-98% (95-98% in each method category) when an outlying laboratory in glucose was omitted, with a concomitant decrease in the interaction component (representing laboratory-dependent variation with time). This indicates that a substantial part of the variation comes from intralaboratory variation with time rather than from constant interlaboratory differences. Normality and consistency of statistical distributions were best achieved in the long-term intralaboratory sets of the data, under which conditions the statistical estimates of error variability were also most characteristic of the individual laboratories rather than necessarily being similar to one another. Mixing of data from different laboratories may give heterogeneous and nonparametric distributions and hence is not advisable.(ABSTRACT TRUNCATED AT 400 WORDS)