Pre Analytical Errors as Quality Indicators in Clinical Laboratory

The ISO 15189: 2012 standard for laboratory accreditation defines the preanalytical phase and recognizes the need to evaluate, monitor and improve all the procedures and processes in the initial phase of the Total Testing Process, including those performed in the phase of requesting tests and collecting samples, the so-called “pre pre-analytical phase”. Pre analytical phase is the most vulnerable part of the Total Testing Process. Errors in this stage can lead to a misdiagnosis and mismanagement and represent a serious harm for patients. Clinical Laboratories use many different methods to reduce errors and improve quality, including the assessment and monitoring of all steps of the Total Testing Process using Quality Indicators (QIs) and accreditation of laboratories. A prospective observational study was done in the Medical Biopathology Laboratories of a public secondary hospital, “Sismanoglio” General Hospital of Athens, Greece for a period of 7 months (June 2014 to December 2014). Of the 908.917 total tests received from the hospitalized patients and the patients treated in Emergency and Outpatient Department during the data collection period, 765 samples were found unsuitable for further processing. This accounted for 1.939% of all samples collected in the Medical Biopathology Laboratories. In order to reduce the number of errors in the pre-analytical phase of the Total Testing Process and to achieve the standards of high quality, special attention must be devoted to this process. Continuous monitoring and control will allow the decrease of pre analytical errors. The systematic reporting of these errors could be used as Quality Indicators such the model which the Working Group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has developed.