Abstract

Quality Indicators of the Pre-Analytical PhaseQuality indicatorsare tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (post-analytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force calledLaboratory Errors and Patient Safety (WG-LEPS)with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra- and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and post-analytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.

Highlights

  • According to the ISO 9001 Standard, quality is always relative to requirements

  • In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force called Laboratory Errors and Patient Safety (WG-LEPS) with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety

  • For example, is the definition of quality offered by the Institute of Medicine (IOM) of the National Academies that states: »The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge« [1]

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Summary

Introduction

According to the ISO 9001 Standard, quality is always relative to requirements. This means that the quality of something can be determined by comparing the sum of related characteristics with the sum of necessary requirements. The criteria for the choice of quality indicators have been widely accepted by health organizations, and can be grouped into three conceptual areas: 1) significance, 2) scientific base, and 3) the possibility of measurement, which are elaborated in detail depending on where they are applied When it comes to laboratory medicine, it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation is based on the original brain-to-brain loop concept, described by Lundberg [3, 4] He sketched a series of activities, beginning with the clinical question in accordance with the doctor’s opinion, followed by test selection, sample collection, transportation to the laboratory, analysis, reporting back to the doctor, interpretation and decision making by the clinician [5]. Some authors include a »pre-pre« and a »post-post« analytical phase, in order to identify the activities that follow the initial choice of necessary analyses and their interpretation by the clini-

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