QUALITY INDICATORS IN LABORATORY MEDICINE: THE EXPERIENCE OF A LARGE LABORATORY

BACKGROUND: The use of quality indicators (QIs) is needed to meet the requirements of ISO 15189 or national legi- slation, to provide information and accountability to stakeholders and users, to establish a programme of continual improvement to ensure the quality of care and patient safety. The revision issued in 2007 of ISO 15189 requires the implementation of QIs, but it does not specify what and how QIs have to be used. Only in the revision issued in 2012, the standard reports the definition of QIs and the rationale of their use. In this context, some years ago, our depart- ment designed a QIs system as a part of a coherent and integrated quality improvement strategy. The aim of this work is to report the procedure used to manage QIs and the results obtained. METHODS: 62 QIs have been identified for the key processes (35 pre-; 13 intra- and 5 post-analitycal phase; 5 POCT), and 4 the support processes. For each QI, an operative procedure and procedural forms describing the rationale, the data collection method to be used, the quality specification to compare data and responsibility, have been defined. A computer application has been create to guarantee an accurate, standardized and traceable data collection. Collected data were processed and results analysed to identify the needed actions. RESULTS: Some QIs results (percentage) collected in 2009 and 2013, are reported as example. Errors concerning the input of request data: 2.2-0.18 (outpatients) and 0.64-0.078 (inpatients), haemolysed samples: 1.69-1.04; insuffi- cient sample volume: 0.09-0.014; inadequate sample-anticoagulant: 0.75-0.60; inappropriate containers: 0.064-0.043; unacceptable results in IQC: 3.93-1.40; unacceptable performances in EQA/PT: 3.75-1.67. Turn Around Time (minutes) of Potassium: 50.7-44.83 (STAT) and 84.8-77.3 (routine). CONCLUSIONS: Results demonstrate a general improving for the most of QIs. The improving actions implemented (i.e. training events organized and informative documents issued in order to decrease the error of request data input and of samples unsuitability for administrative and for inside and outside lab staff, respectively) have been effective. The monitoring of performances using QIs is an important tool to assure the improving process and guarantee the patient safety.