Abstract
Edited by James Westgard and Sten Westgard
London: Elsevier, 2013
205 pp, Price £44.09
ISBN: 978-1-4557-7110-3
This is another piece of work from the Westgards (father and the son) presenting new advances in the field of quality to laboratory medicine specialists. The book is a collection of articles, written by leading experts on quality in laboratory medicine. The preface summarizes all the articles presented in the book and at the beginning of each chapter bulleted ‘key points’ describe what the article is about, which helps those who are familiar with the material presented to move on to the next chapter without feeling that they missed the general flow of the book. One of this book’s strong points is the way that it links a variety of subjects related to analytical quality through an overall objective of designing an ‘individualised Internal Quality Control Plan (IQCP) that meets the intended clinical need for the test’.
As expected given the title, the first article gives a risk management perspective on developing an IQCP that is customized to the laboratory environment, but equally considers patients’ needs. Although the IQCP focuses primarily on the analytical phase, the linking of this process to the clinical need means that pre-analytical and post-analytical considerations are part of the overall risk assessment. The final outcome of the risk estimation is that the IQCP mitigates the risk of production of erroneous test results.
The book goes on to discuss the new regulations that demand the introduction of risk management. Use of IQCPs is currently voluntary under clinical laboratory improvement amendments (CLIA) regulations in the USA. However, there are now plans to replace current IQC procedures with IQCPs based on risk assessment. This book will therefore provide a practical guide for laboratories in the USA as this transition period approaches.
Westgard explains the connection between the new risk assessment-based IQC approach and ISO15189. The latter addresses the concept of appropriate QC procedure thus: ‘The laboratory shall design internal quality control systems that verify the attainment of the intended quality of results’. For laboratories that do not fall under the umbrella of CLIA regulations, this concept of risk assessment through the use of an IQCP remains a very useful tool to maintain compliance with the requirements of ISO15189.
The authors describe some of industry’s famous methodologies for risk assessment such as failure mode and effect analysis. This is one of several transfers from industry to laboratory medicine, and it has proved to be a powerful tool in determining the likely frequency and severity of a risk. However, the authors also carefully highlight the drawbacks of this method’s application in laboratory medicine. They re-introduce the old concept of Six Sigma as a practical tool to determine the risks associated with the analytical phase and develop an IQCP that can mitigate the identified risk.
The remainder of the book presents other approaches to monitoring quality, spanning all phases in laboratory medicine: pre-analytical, analytical and post-analytical. Yundt-Pacheco and Parvin describe a scientific method which uses the concept of risk assessment to determine IQC frequency. Straseski and Strathemann gave an account on the use of patient population data as an additional QC approach, and a guide to analytes for which delta checking is best applied. Extremely useful examples of thorough method evaluation and systematic error assessment are given. The book also provides information on how to include a range of QC components in auto-verification by Laboratory Information Systems. This topic will be of greater importance for laboratories when accreditation is based on ISO15189.
Although it may seem that some old material such as statistical rules and analytical quality specifications is repeated, these topics are introduced in the context of a new approach to integrated quality control based on the principles of risk management. The clear message of this book is that risk management is not a replacement for our old approach to IQC, but rather a further evolution in the concept of quality control that we should embrace and integrate with more traditional tools.
Quality is always considered to be a dry topic, so it is not expected that this book will be an easy read for non-specialists. However, it has a good mix of theory and practical examples, and readers may select chapters that are relevant to their interest or need. I believe that the comprehensive approach to quality presented makes Quality Control in Risk Management a valuable resource for teaching the principles of quality in laboratory medicine and positions it as a useful reference during the forthcoming changes in the world of quality.