The Clinical Laboratory and the Commitment to Quality

Abstract

The main role that clinical laboratories play in the detection, diagnosis, and treatment of diseases is clearly evident. Clinical laboratories need to sustain a commitment to quality and demonstrate a certifiable level of compliance. Many strategies are used to reduce laboratory errors, including internal QC procedures, external quality assessment programs, implementation of QIs and six-sigma methodology. All strategies should be consistent with the requirements of the international standard for medical laboratory accreditation and suitable for promoting corrective/preventive actions. They must promote total quality and patient safety and be consistent with the definition of a laboratory error. Harmonization process is in progress; however, further efforts must be made. Total quality management must be evaluated periodically. For a patient-centered approach, there is the need to assure that each and every step of the total testing process is correctly performed, that weaknesses are recognized, and that corrective and preventive actions are designed and implemented.