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Clinical Chemistry: Laboratory Management and Clinical Correlations
BOOK REVIEWS
REAL classification of lymphoma, acute and chronic leukaemias, and myelodysplastic syndromes. Each case has a representative clinical history followed by a paragraph on flow cytometry and, where appropriate, notes on relevant investigations such as genotyping. This is followed by a discussion which includes morphology, immunophenotype, other special tests, genetics and clinical manifestations. The differential diagnosis is covered in the discussion but it is not a formal section heading. There are numerous colour and black and white illustrations of morphology, genetics and flow cytometer graphs. Information is presented in a tabular format where possible. Therapy is not discussed. References have been updated and appear current and quite extensive. The book is not dissimilar to the World Health Organization classification of lymphomas. The latter probably has better illustrations of lymphoma morphology and much of the discussion is similar. As expected, the atlas has more emphasis on flow cytometry. Even in this area, there may be a need for larger and more targeted references, particularly on technical aspects. The discussion chapters providing the clinical context would be useful for scientific staff. The introductory chapters are quite interesting as a refresher for areas outside a specific subspecialty or interest. Once a diagnostic case has been narrowed to a reasonable differential diagnostic, the case studies are a useful checklist and guide to confirming a diagnosis. The issue of therapy is not addressed and I feel that the principles of therapy would have been useful to both pathologists and scientists. This book will not replace the need for some larger reference texts. However, the broad coverage and the concise and tabular format makes it is useful as a guide and prompt for further investigations and as an introduction to the subject of haematological malignancy. Stuart Galloway St Vincents Pathology, Melbourne, Victoria Clinical Chemistry: Laboratory Management and Clinical Correlations KENT LEWANDROWSKI, EDITOR. Lippincott Williams and Wilkins, Philadelphia, 2002. ISBN 0-683-30085-7, Hardcover, pp xiiiz952, US$125 This 952-page book provides broad, excellent coverage of the topics of relevance to managing a clinical chemistry laboratory. The book is divided into three sections, covering management issues, instrumentation and methods, and clinical aspects of individual analytes. Each chapter is written by different author(s), clearly expert(s) in their field, and contains the most up-to-date information. The book’s most notable strength is that, throughout its 60 chapters, there is a careful balance between the complexity of specific details and presentation for ease of reading and understanding. There are also frequent, practical and highly useful references to actual laboratory experiences. It superbly achieves its objectives of providing core laboratory management teaching, with sufficient working knowledge of laboratory methods, technology and clinical information, for either the trainee pathologist or scientist to prepare for a role in laboratory management. The opening chapter outlines the relevant context, issues and challenges for the modern clinical chemistry laboratory, followed by an up-to-date chapter on current regulation of this industry in the US. Whilst the details of regulatory bodies are specific to the US, the concepts and structure presented in this chapter are nevertheless still highly applicable in Australia and elsewhere. The use of tables and lists efficiently conveys a considerable volume of information. The chapters on human resources and laboratory safety provide concise, useful overviews of these topics, as do the chapters on budget management, benchmarking and cost accounting. The inclusion of simplified examples of a budget report from a small laboratory, budget proposals for new equipment, a benchmarking report and transfer pricing, clearly illustrate relevant concepts of these topics. Lengthy discussions are avoided in the chapter on the role of the laboratory manager and this chapter best serves as a checklist of the topics and issues that are the concerns of the laboratory manager. The up-todate presentation on quality control and quality assurance includes many of the ‘new’ concepts currently being incorporated into modern laboratory services. The content on theory is not extensive, the great benefit being that it is easy to read and understand these concepts. The chapter on diagnostic accuracy covers the topics of assay sensitivity, specificity, predictive value, Bayes’ formula and receiver operating curves in an ideal, simplified manner for the uninitiated. An error worth noting, however, is that on page 115, in the second last paragraph, it states: ‘In contrast, if ones opts to increase the cut off…the sensitivity of the
275
test will increase.’ The last word of this sentence should, of course, be ‘decrease’. The chapter on method evaluation serves almost as a practical guide on aspects of assay performance to consider when setting up new methods. A number of practical case studies are also presented in the following chapter on operations analysis and re-engineering. Information on reimbursement for laboratory services are based on US practices, but similar models are also adopted in Australia or being considered for introduction. Especially relevant are the chapters on point of care (POCT), acute care and STAT testing, since much change has occurred recently in these areas and therefore older texts do not contain such up-to-date discussions. There is a balanced presentation of these topics, including issues and factors that both contribute to and hinder cost effectiveness of POCT and STAT, with illustrative case examples. The next chapter on specimen transport and processing includes many helpful and practical tips for handling different sample types for various requested tests. The brief chapter on integrated automation includes an overview of the various alternatives of robotic systems, conveyor belt, total laboratory automation and automation of key processes. A number of different products by several manufacturers are briefly described. Although not of direct concern to the laboratory manager, the chapter on development of instrument platforms presents an interesting insight into a manufacturer’s planning and processes. Information on assay development and the Food and Drug Administration is particularly relevant for Australia, with current proposals by the Therapeutic Goods Administration to increase its regulations. Possibly due to the emphasis placed on the value of computer knowledge, the two chapters on laboratory information systems are especially comprehensive for a general textbook. For the computer-naive, this serves as an excellent introduction to computer technology for the laboratory. The four chapters on integrated delivery systems, the commercial reference laboratory, management of test utilisation and role of the diagnostic industry, reflect contemporary evolution of the laboratory and industry which have been largely driven by pressures of cost and service delivery. Discussions of these contemporary issues are unlikely to be found in older reference texts. In all, this first section of the book covers well the main management topics and issues. In particular, a number of chapters cover contemporary issues that would not be available in older references texts. The entire section presents information in the simplest and clearest manner. The second section of this textbook covers the methodology principles of measurement units, reference values, photometry, fluorometry, nephelometry, turbidimetry, atomic absorption, mass spectrometry, chromatography, capillary electrophoresis, electrochemistry, electrophoresis, osmolality and specific gravity, enzymology, and radioimmunassay, in a straightforward manner with an appropriate theoretical content, ideal for those who require only a background knowledge for laboratory management. Each of these chapters conforms to the book’s stated objective of providing working, practical knowledge and all are remarkably easy to read and understand. Readers who require more specific details on a topic are directed to references at the end of each chapter. Several chapters in this section are worth particular comment. The chapter on contemporary instruments is co-authored by the editor himself and is unlikely to be found in older texts. It lists the likely tests that are present or required in today’s clinical chemistry laboratory and briefly details features of a number of different analysers from various major manufacturers. Most of these would be familiar to readers already working in a clinical chemistry, but the chapter is most useful for those who have not recently been involved in core clinical chemistry. Significant developments have recently occurred in the area of immunoassays and two chapters have been devoted to this topic. The subject matter is reasonably well covered, but a slightly disappointing aspect of Chapter 28 is that it appears to be written from the perspective of a single manufacturer and does not fully represent technological developments made by other manufacturers. Molecular diagnostics is another rapidly developing field that is covered in Chapter 34. The author outlines different molecular approaches for amplification and detection of DNA and RNA and the various clinical diagnostic uses, including some specific examples of human clinical diseases. Clearly, the topic is too immense to be discussed in any detail and the author has included a good selection of references for further reading on each method, at the end of this chapter. The third and last section of this book covers individual analytes in clinically related groups. Once again, these chapters are written with the appropriate depth intended to provide good working knowledge for
276
BOOK REVIEWS
the person in a managerial role, and are easy to read. Though concise, the chapters contain up-to-date information. Notably, in addition to the widely accepted use of troponin, newer and experimental cardiac markers, such as CRP, carbonic anhydrase III, free fatty acid binding protein, albumin cobalt binding and brain natriuretic peptide, are also discussed. In the chapter on lipids, the NCEP guidelines for coronary risk assessment now include a further revision, the Adult Treatment Panel III, not included due to the timing of publication. The use of flowcharts to summarise diagnostic pathways in lipid, thyroid, endocrine, acid–base, electrolyte, respiratory, cardiac, renal, calcium, phosphate, liver, iron and pregnancy disorders, are particularly useful features in these chapters. The coagulation service is often a separate section of the pathology organisation to clinical chemistry, although, like many clinical chemistry tests, it is often required as a STAT service. A chapter on this topic seems like a bonus in this book. The only disappointment in this section is that, in an entire chapter devoted to pancreatic and gastrointestinal disease, there is sparse information on lipase. Considering that this book aims to be a significant
Pathology (2003), 35, June contemporary text on clinical chemistry, albeit on laboratory management aspects, this is a somewhat conspicuous omission. Other topics that are covered well in this section include plasma proteins, glucose and carbohydrates, lipids, pituitary and adrenal disorders, neuroendocrine tumours, reproductive endocrinology, inborn errors of metabolism, toxicology, therapeutic drug monitoring, trace elements, vitamins and nutrition, disorders of porphyrin synthesis, clinical chemistry of urine, pleural and peritoneal fluids, tumour markers, cerebrospinal fluid, and disorders of bone chemistry. In summary, this is an excellent teaching reference which provides a great practical overview of the clinical, methodological and administrative aspects of clinical chemistry laboratory management. I highly recommend this book to those, of either clinical or scientific background, preparing for a role in laboratory management and to any staff working in a clinical chemistry laboratory seeking to advance their knowledge or career. Lisa Koe Royal North Shore Hospital St Leonards, New South Wales
REAL classification of lymphoma, acute and chronic leukaemias, and myelodysplastic syndromes. Each case has a representative clinical history followed by a paragraph on flow cytometry and, where appropriate, notes on relevant investigations such as genotyping. This is followed by a discussion which includes morphology, immunophenotype, other special tests, genetics and clinical manifestations. The differential diagnosis is covered in the discussion but it is not a formal section heading. There are numerous colour and black and white illustrations of morphology, genetics and flow cytometer graphs. Information is presented in a tabular format where possible. Therapy is not discussed. References have been updated and appear current and quite extensive. The book is not dissimilar to the World Health Organization classification of lymphomas. The latter probably has better illustrations of lymphoma morphology and much of the discussion is similar. As expected, the atlas has more emphasis on flow cytometry. Even in this area, there may be a need for larger and more targeted references, particularly on technical aspects. The discussion chapters providing the clinical context would be useful for scientific staff. The introductory chapters are quite interesting as a refresher for areas outside a specific subspecialty or interest. Once a diagnostic case has been narrowed to a reasonable differential diagnostic, the case studies are a useful checklist and guide to confirming a diagnosis. The issue of therapy is not addressed and I feel that the principles of therapy would have been useful to both pathologists and scientists. This book will not replace the need for some larger reference texts. However, the broad coverage and the concise and tabular format makes it is useful as a guide and prompt for further investigations and as an introduction to the subject of haematological malignancy. Stuart Galloway St Vincents Pathology, Melbourne, Victoria Clinical Chemistry: Laboratory Management and Clinical Correlations KENT LEWANDROWSKI, EDITOR. Lippincott Williams and Wilkins, Philadelphia, 2002. ISBN 0-683-30085-7, Hardcover, pp xiiiz952, US$125 This 952-page book provides broad, excellent coverage of the topics of relevance to managing a clinical chemistry laboratory. The book is divided into three sections, covering management issues, instrumentation and methods, and clinical aspects of individual analytes. Each chapter is written by different author(s), clearly expert(s) in their field, and contains the most up-to-date information. The book’s most notable strength is that, throughout its 60 chapters, there is a careful balance between the complexity of specific details and presentation for ease of reading and understanding. There are also frequent, practical and highly useful references to actual laboratory experiences. It superbly achieves its objectives of providing core laboratory management teaching, with sufficient working knowledge of laboratory methods, technology and clinical information, for either the trainee pathologist or scientist to prepare for a role in laboratory management. The opening chapter outlines the relevant context, issues and challenges for the modern clinical chemistry laboratory, followed by an up-to-date chapter on current regulation of this industry in the US. Whilst the details of regulatory bodies are specific to the US, the concepts and structure presented in this chapter are nevertheless still highly applicable in Australia and elsewhere. The use of tables and lists efficiently conveys a considerable volume of information. The chapters on human resources and laboratory safety provide concise, useful overviews of these topics, as do the chapters on budget management, benchmarking and cost accounting. The inclusion of simplified examples of a budget report from a small laboratory, budget proposals for new equipment, a benchmarking report and transfer pricing, clearly illustrate relevant concepts of these topics. Lengthy discussions are avoided in the chapter on the role of the laboratory manager and this chapter best serves as a checklist of the topics and issues that are the concerns of the laboratory manager. The up-todate presentation on quality control and quality assurance includes many of the ‘new’ concepts currently being incorporated into modern laboratory services. The content on theory is not extensive, the great benefit being that it is easy to read and understand these concepts. The chapter on diagnostic accuracy covers the topics of assay sensitivity, specificity, predictive value, Bayes’ formula and receiver operating curves in an ideal, simplified manner for the uninitiated. An error worth noting, however, is that on page 115, in the second last paragraph, it states: ‘In contrast, if ones opts to increase the cut off…the sensitivity of the
275
test will increase.’ The last word of this sentence should, of course, be ‘decrease’. The chapter on method evaluation serves almost as a practical guide on aspects of assay performance to consider when setting up new methods. A number of practical case studies are also presented in the following chapter on operations analysis and re-engineering. Information on reimbursement for laboratory services are based on US practices, but similar models are also adopted in Australia or being considered for introduction. Especially relevant are the chapters on point of care (POCT), acute care and STAT testing, since much change has occurred recently in these areas and therefore older texts do not contain such up-to-date discussions. There is a balanced presentation of these topics, including issues and factors that both contribute to and hinder cost effectiveness of POCT and STAT, with illustrative case examples. The next chapter on specimen transport and processing includes many helpful and practical tips for handling different sample types for various requested tests. The brief chapter on integrated automation includes an overview of the various alternatives of robotic systems, conveyor belt, total laboratory automation and automation of key processes. A number of different products by several manufacturers are briefly described. Although not of direct concern to the laboratory manager, the chapter on development of instrument platforms presents an interesting insight into a manufacturer’s planning and processes. Information on assay development and the Food and Drug Administration is particularly relevant for Australia, with current proposals by the Therapeutic Goods Administration to increase its regulations. Possibly due to the emphasis placed on the value of computer knowledge, the two chapters on laboratory information systems are especially comprehensive for a general textbook. For the computer-naive, this serves as an excellent introduction to computer technology for the laboratory. The four chapters on integrated delivery systems, the commercial reference laboratory, management of test utilisation and role of the diagnostic industry, reflect contemporary evolution of the laboratory and industry which have been largely driven by pressures of cost and service delivery. Discussions of these contemporary issues are unlikely to be found in older reference texts. In all, this first section of the book covers well the main management topics and issues. In particular, a number of chapters cover contemporary issues that would not be available in older references texts. The entire section presents information in the simplest and clearest manner. The second section of this textbook covers the methodology principles of measurement units, reference values, photometry, fluorometry, nephelometry, turbidimetry, atomic absorption, mass spectrometry, chromatography, capillary electrophoresis, electrochemistry, electrophoresis, osmolality and specific gravity, enzymology, and radioimmunassay, in a straightforward manner with an appropriate theoretical content, ideal for those who require only a background knowledge for laboratory management. Each of these chapters conforms to the book’s stated objective of providing working, practical knowledge and all are remarkably easy to read and understand. Readers who require more specific details on a topic are directed to references at the end of each chapter. Several chapters in this section are worth particular comment. The chapter on contemporary instruments is co-authored by the editor himself and is unlikely to be found in older texts. It lists the likely tests that are present or required in today’s clinical chemistry laboratory and briefly details features of a number of different analysers from various major manufacturers. Most of these would be familiar to readers already working in a clinical chemistry, but the chapter is most useful for those who have not recently been involved in core clinical chemistry. Significant developments have recently occurred in the area of immunoassays and two chapters have been devoted to this topic. The subject matter is reasonably well covered, but a slightly disappointing aspect of Chapter 28 is that it appears to be written from the perspective of a single manufacturer and does not fully represent technological developments made by other manufacturers. Molecular diagnostics is another rapidly developing field that is covered in Chapter 34. The author outlines different molecular approaches for amplification and detection of DNA and RNA and the various clinical diagnostic uses, including some specific examples of human clinical diseases. Clearly, the topic is too immense to be discussed in any detail and the author has included a good selection of references for further reading on each method, at the end of this chapter. The third and last section of this book covers individual analytes in clinically related groups. Once again, these chapters are written with the appropriate depth intended to provide good working knowledge for
276
BOOK REVIEWS
the person in a managerial role, and are easy to read. Though concise, the chapters contain up-to-date information. Notably, in addition to the widely accepted use of troponin, newer and experimental cardiac markers, such as CRP, carbonic anhydrase III, free fatty acid binding protein, albumin cobalt binding and brain natriuretic peptide, are also discussed. In the chapter on lipids, the NCEP guidelines for coronary risk assessment now include a further revision, the Adult Treatment Panel III, not included due to the timing of publication. The use of flowcharts to summarise diagnostic pathways in lipid, thyroid, endocrine, acid–base, electrolyte, respiratory, cardiac, renal, calcium, phosphate, liver, iron and pregnancy disorders, are particularly useful features in these chapters. The coagulation service is often a separate section of the pathology organisation to clinical chemistry, although, like many clinical chemistry tests, it is often required as a STAT service. A chapter on this topic seems like a bonus in this book. The only disappointment in this section is that, in an entire chapter devoted to pancreatic and gastrointestinal disease, there is sparse information on lipase. Considering that this book aims to be a significant
Pathology (2003), 35, June contemporary text on clinical chemistry, albeit on laboratory management aspects, this is a somewhat conspicuous omission. Other topics that are covered well in this section include plasma proteins, glucose and carbohydrates, lipids, pituitary and adrenal disorders, neuroendocrine tumours, reproductive endocrinology, inborn errors of metabolism, toxicology, therapeutic drug monitoring, trace elements, vitamins and nutrition, disorders of porphyrin synthesis, clinical chemistry of urine, pleural and peritoneal fluids, tumour markers, cerebrospinal fluid, and disorders of bone chemistry. In summary, this is an excellent teaching reference which provides a great practical overview of the clinical, methodological and administrative aspects of clinical chemistry laboratory management. I highly recommend this book to those, of either clinical or scientific background, preparing for a role in laboratory management and to any staff working in a clinical chemistry laboratory seeking to advance their knowledge or career. Lisa Koe Royal North Shore Hospital St Leonards, New South Wales