How to achieve harmonisation of laboratory testing -The complete picture

Abstract

Harmonisation is likely to be an important contributor to ensure high quality laboratory testing, thus potentially improving patient outcome. Efforts for harmonisation must be made in the total testing process, from test requesting to communication of the laboratory test results and its consequences to the patient. In this article, suggestions are given about what level of harmonisation is possible at the various steps of the testing process, who could be responsible for facilitating and monitoring the effects of harmonisation, and what are likely barriers to achieving harmonisation. Harmonisation can be achieved at local, national and international levels, and will be most challenging when it involves more than one profession as in the extra-analytical phases. Key facilitators will be laboratory associations, regulatory bodies and accreditation systems, whereas barriers are likely to be reimbursement systems or economic factors, opinion leaders and manufacturers. A challenge is to try to turn barriers into facilitators. Harmonisation effects can in most settings be monitored by external quality assurance organisations provided that schemes are expanded to cover all relevant steps and phases. We must combine our efforts, both within our profession as well as in cooperation with others, to achieve harmonisation of the total testing process, in the best interests of the patient.

Keywords: External quality assurance; Harmonisation; Laboratory management; Post-analytical; Pre-analytical; Total testing process.