Abstract

AbstractLaboratory medicine in the healthcare system has recently been recognized as a fundamental service in the clinical decision-making process. Therefore, the notion of patient safety in laboratory medicine must be recognized as the assurance that harm to patients will be avoided, safe care outcomes will be enhanced through error prevention, and the total testing process (TTP) will be continuously improved.Although the goal for patient safety is zero errors, and although laboratory professionals have made numerous efforts to reduce errors in the last few decades, current research into laboratory-related diagnostic errors highlights that: (a) errors occur at every step of the TTP, mainly affecting phases at clinical interfaces; (b) despite the improvement strategies adopted, analytical quality remains a challenge; (c) errors are linked not only to clinical chemistry tests, but also to new, increasingly complex diagnostic testing.Medical laboratories must therefore implement effective quality assurance tools to identify and prevent errors in order to guarantee the reliability of laboratory information. Accreditation in compliance with the International Standard ISO 15189 represents the first step, establishing processes with excellence requirements and greater expectations of staff competency. Another important step in preventing errors and ensuring patient safety is the development of specific educational and training programs addressed to all professionals involved in the process, in which both technical and administrative skills are integrated. A wide variety of information is provided by a robust quality management system and consensus-approved Quality Indicators (QI) that identify undesirable events, evaluate the risk to the patient, and call for corrective and preventive actions. However, the effectiveness of the system depends on the careful analysis of data collected and on staff awareness of the importance of laboratory medicine to the healthcare process. The main task of the new generation of laboratory professionals should be to gain experience in “clinical laboratory stewardship.” In order to safeguard patients, laboratory professionals must assist clinicians in selecting the right test for the right patient at the right time and facilitate the interpretation of laboratory information.

Highlights

  • In the last few decades, changes in the nature of laboratory services have underscored a paradigmatic transformation of the laboratory scenario [1] thanks to technological innovation, the introduction of ever more complex tests in emerging diagnostic fields, more advanced diagnostics, and other internal and external drivers

  • In the ten points identified in the “Manifesto for the future of Laboratory Medicine professionals” (Table 24.1), great emphasis is placed on the importance of cooperation in reducing the risk of diagnostic errors, the implementation of reliable laboratory medicine stewardship, the involvement of laboratory medicine professionals in interdisciplinary teams, and the promotion of professional expertise

  • Other authors have reported that about 30% of cases of error in total laboratory testing translate into a patient care problem [14–16]

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Summary

24.1.1 Laboratory Medicine as a Driver in Ensuring Patient Safety

The phrase “clinical laboratory stewardship” effectively clarifies the indispensable role of. In order to reduce errors and improve quality of care, laboratory professionals must be made aware of the impact laboratory results have on the patient and, on the other hand, clinicians must have a thorough understanding of the tools implemented and used in the laboratory [3–5]. Other authors have reported that about 30% of cases of error in total laboratory testing translate into a patient care problem (e.g., inappropriate admission to critical care units, inappropriate transfusions, modifications in heparin and digoxin therapies) [14–16]. These data demonstrate the importance of laboratory information in clinical decision-­ making since it can significantly affect the diagnosis and subsequent patient management [17]. It is acknowledged worldwide that the fundamental role of laboratory medicine is to ensure patient safety, more could be done to highlight this role in order to make the laboratory’s work visible to the patient

24.1.2 From Laboratory-Related Errors to Diagnostic Errors
24.2 Safety Practices and Implementation Strategy
24.2.1 ISO 15189 Accreditation
24.2.2 Quality Indicators
53 Measurements
24.2.3 Professional Competence
24.2.4 Risk Management Procedures
Findings
56. World Health Organization
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