Proposed guidelines for the internal quality control of analytical results in the medical laboratory.

The factors involved in analytical quality relate to definition of quality, creation of quality, and control of quality, and errors arise from external and internal sources as well as from permanent and variable factors. Further, the two main types of error are classified as systematic and random errors. Internal quality control (IQC) systems can only operate on the variable factors which are related to batch-to-batch variations (external factors) and to the performance in the laboratory (internal factors). In creating an adequate internal control system, several problems are faced: (i) quality of control materials, (ii) types and frequency of possible errors, (iii) number and types of control materials, (iv) number of replicates of the control, (v) probability of error detection, (vi) probability of false rejection, (vii) consequences of reject signals, (viii) trouble-shooting systems, and (ix) prevention of errors among many other conditions. Gaussian distributions of control results are assumed and the statistical control rules are evaluated in relation to probability of false rejections, Pfr, and probability of error detection, Ped, for the different rules. Combinations of low Pfr and high Ped are obtained by combining results from e.g. four measurements of the same control sample by use of mean and range rules. Further, it is not possible to establish a common control system which can be used for all quantities and analytical procedures; on the contrary, each procedure should have its particular efficient IQC system. These aspects are discussed and a number of guidelines for statistical control rules and problem related internal quality control are presented.