Portuguese EQAS vision versus experience on pre-analytical phase (2007-2011)

Portuguese EQAS vision versus experience on pre-analytical phase (2007-2011) Ana Faria, Helena Correia, M. Adelina Gomes Instituto Nacional de Saúde Dr Ricardo Jorge, Lisboa, Portugal (Gabinete de Avaliação Externa da Qualidade Laboratorial) Introduction: According to recent bibliography it's in the pre-analytical phase, that a predominance of errors is observed (32 to 75%) that are not noticed or are overlooked in assessment procedures or result interpretation. It became, therefore, important to monitor its use, as well as the absolute necessity to compare and standardize procedures. In 2007 the Evaluation of Pre-Analytic Phase was implemented, now part of the 77 existing Clinical Programs in the National External Quality Assessment of the National Institute of Health, Portugal. Objective: The main objective of this program is to evaluate the performance of participants in order to improve the performance of clinical laboratories nationwide in the pre-analytical phase. This study evaluated the results obtained in nine surveys by laboratories participating in the PNAEQ. Methods: Between 2007 and 2011 laboratories enrolled in theEvaluation in Pre-Analytic Phase program, 2 surveys per year. We distributed questionnaires, samples, case studies, medical request simulation, sample handling simulation, considerations for compliance of national legislation and guidelines of the General Directorate of Health, contents of collection manual or collection instructions, emergency situations, different conditions for special collection, collections in sampling stations, cases of drugs interference, questions about sample storage and transport , biosafety considerations, equipment and sample material, criteria for sample rejection, control and reagent preparation, record of traceability of the pre-analytical process over the nine surveys. We requested, when applicable, the classification of the recorded errors, with PNAEQ’s comments and clarification. The results were statistically analyzed, frequency charts performed, according with clients answers. In each survey a joint report was prepared with the overall results and pertinent comments. Results: In 5 years of this program 105 laboratories were enrolled with an average participation of 44%. Fifty seven percent enrolled only once, and only 14% maintained their registration with participation in four or more years. The highest percentage of answers received was in surveys that included shipment of samples with simulated clinical history (44 to 65%) or case studies (63%). In these surveys we considered some incomplete comments, but all correct. In patient registration and error detection in simulated medical request, participants submitted their comments on the most appropriate and complete. For questions asked on control records and reagent preparation, questionnaires with accounting errors and biosafety situations, we have not had significant response. We consider we are still in the sensibilization process of laboratories, trying to highlight the importance of participation in this program. In the report cards information is sent on critical points inherent in this phase. Conclusion: Although there has been a good first year in participation, there was a decrease in the number of laboratories enrolled over the years (in 2011less than 1/3 compared to 2007) but with a tendency to an increase active participation in surveys that included sample analysis and case study. Although with an average participation in the first survey of only 27%, the percentage of reported errors is consistent with those described in the literature. On this date there was no indication of automation of the pre analytical phase in laboratories. Laboratories that had an assiduous involvement in 4/ 5 years have the quality management system implemented, a facilitating tool for a response to the program, demonstrating a practice of procedures with records for detection and quantification of errors in different phases of the analytical process. Not reporting errors, does not mean their absence. It was in the information content of the Collection Manual and in simulated analysis with samples sent that we verified the existence of good practice procedures. The practice of recording in order to trace the entire pre analytical procedure will allow its monitoring. We believe that the formative part of this program may warn, encourage and sensitize the participants to errors that may occur at the beginning of the analytical process. It was always proposed that the laboratory staff members jointly reviewed the report card, so that they can draw conclusions and make the self-evaluation. As main objective, we have the evaluation of the impact of errors in future trials