Error budget calculations in laboratory medicine: linking the concepts of biological variation and allowable medical errors

Background: Random, systematic and sporadic errors, which unfortunately are not uncommon in laboratory medicine, can have a considerable impact on the well being of patients. Although somewhat difficult to attain, our main goal should be to prevent all possible errors. A good insight on error-prone steps in the laboratory process is essential to achieving a structured system for error reduction. Methods: Here, the process of laboratory medicine is divided into phases, and for each phase, an error frequency is presented. While error frequencies in the laboratory (pre-analytical to post-analytical) have been reported elsewhere, we also include them in the present paper. In order to investigate error frequencies in the pre-pre- and post-post-analytical phases, clinicians were asked to carefully answer questions concerning their ordering strategies for laboratory investigation and their interpretation of results. Results: In the present study, the overall error rate in laboratory medicine was found to be 20.0%. The error percentages in the pre-pre- and post-post-analytical phase were about 12.0% and 5.0%, respectively. This indicates that, also on the clinical side, error reduction is desirable, especially in the requesting of laboratory investigation. Error reduction can be achieved through process redesigning by, for example, applying the Hazard Analysis and Critical Control Points approach. The error budget that clinicians might spend, based upon critical differences, is 26.9%. For the same test set and production circumstances, the overall biological variation is 7.9%. Clinicians thus take the error rates into account in their practical, daily use, and the ultimate achievable in laboratory medicine is biological variation. Conclusions: Several currently available software applications can aid error reduction in clinical chemistry. Both laboratory consultants and the use of information and communication technology are essential tools in optimizing the efficiency of laboratory medicine