Risk management in the preanalytical phase of laboratory testing
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Giuseppe Lippi
Abstract
The clinical laboratory is no longer its own limited ecosystem, as it is increasingly integrated with patient care, assisting diagnosis, monitoring therapies and predicting clinical outcomes. Although efforts and resources are continuously focused to achieve a satisfactory degree of analytical quality, there is clear evidence that the preanalytical phase is much more vulnerable to uncertainties and accidents, which can substantially influence patient care. Most errors within the preanalytical phase result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to in vitro hemolysis, clotting, insufficient volume, wrong container, contamination and misidentification. A reliable approach to overcome this problem entails prediction of accidental events (exhaustive process analysis, reassessment and rearrangement of quality requirements, dissemination of operating guidelines and best-practice recommendations, reduction of complexity and error-prone activities, introduction of error-tracking systems and continuous monitoring of performances), an increase in and diversification of defenses (application of multiple and heterogeneous systems to identify non-conformities), and a decrease in vulnerability (implementation of reliable and objective detection systems and causal relation charts, education and training). This policy, which requires integration between requirements and design, full commitment and interdepartmental cooperation, should make laboratory activity more compliant to the inalienable paradigm of total quality in the testing process.
Clin Chem Lab Med 2007;45:720–7.
©2007 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Foreword
- Errors in laboratory medicine and patient safety: the road ahead
- How can we make laboratory testing safer?
- “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory
- Risk management in the preanalytical phase of laboratory testing
- Recommendations for detection and management of unsuitable samples in clinical laboratories
- Effects of analytic variations in creatinine measurements on the classification of renal disease using estimated glomerular filtration rate (eGFR)
- Process and risk analysis to reduce errors in clinical laboratories
- Reduction of multi-dimensional laboratory data to a two-dimensional plot: a novel technique for the identification of laboratory error
- Does external evaluation of laboratories improve patient safety?
- Risk management in laboratory medicine: quality assurance programs and professional competence
- Point-of-care testing, medical error, and patient safety: a 2007 assessment
- Blood gas and patient safety: considerations based on experience developed in accordance with the Risk Management perspective
- The role of in vitro diagnostic companies in reducing laboratory error
- Application of the Six Sigma concept in clinical laboratories: a review
- One hundred years of laboratory testing and patient safety
Articles in the same Issue
- Foreword
- Errors in laboratory medicine and patient safety: the road ahead
- How can we make laboratory testing safer?
- “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory
- Risk management in the preanalytical phase of laboratory testing
- Recommendations for detection and management of unsuitable samples in clinical laboratories
- Effects of analytic variations in creatinine measurements on the classification of renal disease using estimated glomerular filtration rate (eGFR)
- Process and risk analysis to reduce errors in clinical laboratories
- Reduction of multi-dimensional laboratory data to a two-dimensional plot: a novel technique for the identification of laboratory error
- Does external evaluation of laboratories improve patient safety?
- Risk management in laboratory medicine: quality assurance programs and professional competence
- Point-of-care testing, medical error, and patient safety: a 2007 assessment
- Blood gas and patient safety: considerations based on experience developed in accordance with the Risk Management perspective
- The role of in vitro diagnostic companies in reducing laboratory error
- Application of the Six Sigma concept in clinical laboratories: a review
- One hundred years of laboratory testing and patient safety
