The role of in vitro diagnostic companies in reducing laboratory error
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Ana K. Stankovic
Abstract
Laboratory errors have a significant impact on patient safety. The manufacturers of in vitro diagnostic (IVD) products play an important role in the reduction of laboratory errors by ensuring the highest possible safety and efficacy of their products. In order to achieve this, the IVD industry has implemented rigorous product development and manufacturing processes. Many IVD companies apply Six Sigma principles in order to minimize variability within the whole product life cycle, starting with customer requirements, through product design and manufacture, as well as management of the potential issues that occur after the products have been released for use. A closer look into this process is presented here, using an evacuated blood collection tube as a model device.
Clin Chem Lab Med 2007;45:781–8.
©2007 by Walter de Gruyter Berlin New York
Artikel in diesem Heft
- 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
Artikel in diesem Heft
- 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
