Ian D Watson

Preanalytical quality improvement: from dream to reality

Abstract Laboratory diagnostics (i.e., the total testing process) develops conventionally through a virtual loop, originally referred to as “the brain to brain cycle” by George Lundberg. Throughout this complex cycle, there is an inherent possibility that a mistake might occur. According to reliable data, preanalytical errors still account for nearly 60%–70% of all problems occurring in laboratory diagnostics, most of them attributable to mishandling procedures during collection, handling, preparing or storing the specimens. Although most of these would be “intercepted” before inappropriate reactions are taken, in nearly one fifth of the cases they can produce inappropriate investigations and unjustifiable increase in costs, while generating inappropriate clinical decisions and causing some unfortunate circumstances. Several steps have already been undertaken to increase awareness and establish a governance of this frequently overlooked aspect of the total testing process. Standardization and monitoring preanalytical variables is of foremost importance and is associated with the most efficient and well-organized laboratories, resulting in reduced operational costs and increased revenues. As such, this article is aimed at providing readers with significant updates on the total quality management of the preanalytical phase to endeavour further improvement for patient safety throughout this phase of the total testing process.

What is the role of cerebrospinal fluid ferritin in the diagnosis of subarachnoid haemorrhage in computed tomography-negative patients?

Abstract Background Spectrophotometry of cerebrospinal fluid (CSF) for bilirubin is the recommended method for investigation in suspected cases of subarachnoid haemorrhage (SAH), when a computed tomography (CT) of the head is negative for blood. There is a potential need for a simpler alternative. Measurement of CSF ferritin might fulfil this need. Method We have measured ferritin in the CSF from 252 patients with suspected SAH who were negative on a CT of the head for blood, recruited on a consecutive intention to recruit basis from four centres. CSF spectrophotometry was performed on all samples. A positive outcome was taken as an aneurysm found on angiography that was treated or a discharge diagnosis of non-aneurysmal SAH. Results A final diagnosis of aneurysmal SAH was made in six patients, an arteriovenous malformation in one and non-aneurysmal SAH in nine. Receiver operating characteristic (ROC) analysis showed that at 6.4 μg/L, sensitivity, specificity, positive and negative predictive values were 1.0, 0.48, 0.12 and 1.0, respectively. At 12 μg/L, these values were 0.81, 0.91, 0.38 and 0.98, respectively. Conclusions At an appropriate negative predictive value (1.0) for a rule-out test, ferritin has too low a specificity to function as a stand-alone test and we cannot recommend it as an initial screen to be followed by spectrophotometry.

Glucose meters – fit for clinical purpose

Abstract Glucose meters have improved considerably since they were first introduced in 1960, but many questions are being asked about their accuracy and reliability in certain clinical situations. These questions have arisen because of the widespread use of these meters into clinical areas they have not been designed for such as critical care. The lack of understanding by some health professionals on factors that affect glucose results, such as sample type, glucose test strip methodologic limitations, calibration to recognized reference methods, and interferences, leads to misleading results that may affect patient care. Much debate continues on the quality specifications for glucose meters. Because there is an extensive use of these meters in different clinical scenarios, the setting of quality specifications will remain a challenge for regulatory and professional organizations. In this article, we have attempted to collect and provide relevant information addressing the limitations above. Pivotal to obtaining the best quality of results is education, particularly for diabetic patients monitoring their glucose. The International Federation of Clinical Chemistry and Laboratory Medicine through its Point-of-Care Testing Task Force and its Working Group on Glucose Point-of-Care Testing is actively working toward improving the quality of glucose results by improving education and working with the industry to improve strip performance and work toward the better standardization of strips.

European views on patients directly obtaining their laboratory test results

Abstract Background: Medicine is a highly professionalized endeavour, by tradition centred on the authority of physicians. Better education and the advent of the information age cater for increased demands on society in general and on health care in particular to enable people to make informed decisions regarding themselves. Participation in medical decisions requires informed knowledge which is hard to obtain without substantial and time consuming professional help. Methods: We performed a survey amongst the member organizations of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in order to investigate the recognition and preparedness of providing help to patients in interpreting their laboratory results. Results: Out of 40 EFLM Member Societies, 27 sent their responses to the survey. In most cases the first line delivery of laboratory results to physicians is by computer link (63%). Patients receive their laboratory results on demand from their physician in 60% of cases. However, 34% of laboratory specialists showed a negative attitude for delivering laboratory results to patients. Yet, in 48% of countries 1–5 patients per day ask a laboratory specialist about the significance of laboratory results outside the reference range. When patients are informed about the purpose of laboratory testing, they seek information primarily from their physician, followed by the internet and the Specialist in Laboratory Medicine. Conclusions: Changing practices increasingly enabling patient access to their records are on the increase facilitated by recent innovations in information technologies. Successful transfer of some of the responsibilities of physicians, demands a mutual triangular dialogue between the patient, their physician and laboratory medicine.

Definitive angiographic detection of subarachnoid haemorrhage compared with laboratory assessment of intracranial bleed in CT-negative patients

Background: Between 2·5% and 5% of cases of subarachnoid haemorrhage (SAH) give negative results for computed tomography (CT) scanning. Recent UK guidelines make recommendations as to standardization of laboratory methodology for the detection of SAH in individuals with a negative CT scan. We have compared this approach with our routine assessment using first-order derivative spectrophotometry, a recently reported iterative computer prediction model and measurement of cerebrospinal fluid (CSF) ferritin concentration. All methods were judged against cerebral angiography as the definitive means of determining patient outcome. Methods: Scanning spectrophotometry of CSF is necessary for both the UK guidelines and our in-house method. Absorbance measurements at 360, 405, 414 and 455 nm are required for the computer model. CSF ferritin concentration was measured using a serum method on a DPC Immulite 2000. This gave a value of <12 µg/L for normal CSF. Ethical approval and informed patient consent to additional investigation were obtained. Results: The sensitivity and specificity for the UK guidelines method, derivative spectrophotometry (in-house), iterative computer model and CSF ferritin were, respectively: 0·8, 1·0; 0·9, 1·0; 0·9, 0·5; 1·0, 0·78. Conclusion: First-order derivative spectrophotometry had best concordance with angiography. Combination of this with CSF ferritin measurement may improve sensitivity, although the zero-order method recommended in the UK guidelines for the detection of an intracranial bleed is more amenable and has comparable performance.

Clinical Chemistry and Laboratory Medicine: an appreciation

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) congratulate Clinical Chemistry and Laboratory Medicine on the occasion of its 50th anniversary. As Presidents of IFCC and EFLM we express our thanks and appreciation to the present and former Editors-in-Chief and to the publishers (DeGruyter) for their contribution to improving the quality and understanding of clinical chemistry and laboratory medicine in the interests of improved patient care. Clinical Chemistry and Laboratory Medicine is a journal published in association with IFCC and EFLM, which means that it is the ‘ official ’ journal of both Federations. Clinical Chemistry and Laboratory Medicine is also the official journal of nine national societies of clinical chemistry and laboratory medicine. This combination gives Clinical Chemistry and Laboratory Medicine a unique place in publishing articles of interest to laboratory medicine specialists. Fifty years ago clinical chemistry and laboratory medicine was an emerging specialism within medicine. The repertoire of laboratory investigations was limited, automation was at an early stage of development and laboratory informatics was little more than a concept. The structure of DNA had been known for < 10 years and the technique of immunoassay had only just been discovered. Quality management was not on anyone ’ s agenda. From these simple statements it is clear to see the huge advances that have been made during the past 50 years to enable the transition into a major branch of medicine that influences up to 70 % of clinical decisions. Today, laboratory medicine has a repertoire of almost 1000 investigations that are delivered in a wide range of clinical settings to a level of quality that cannot be surpassed in any other branch of medicine. Clinical Chemistry and Laboratory Medicine has played an important role in supporting that remarkable transition. The core business of any reputable scientific journal is the publication of original research articles. The quality of these articles may be measured indirectly through the impact factor assigned to the journal. In a highly competitive publishing market the recent yearly improvement in the impact factor achieved by Clinical Chemistry and Laboratory Medicine is a notable achievement. The presentation of these original articles in areas of clinical application is a simple but effective tool that helps the journal to develop focus and helps the reader to appreciate the latest developments in his/her particular field of interest. The huge expansion of laboratory medicine has led to a vast scientific and clinical literature. For laboratory medicine specialists who are responsible for service delivery, including clinical interpretation and future service development, this vast literature is challenging. The availability of Reviews; Mini Reviews; Opinion Papers; Point and Counterpoint; and Guidelines and Recommendations helps these specialists to acquire knowledge and insight in a convenient and timely manner. For our international organisations the publication of the endeavours of our various Working Groups need to be disseminated to communicate the best practice guidance to the members of our national societies. Clinical Chemistry and Laboratory Medicine has been an effective vehicle for such communications as well as regulatory information and occasionally more ‘ philosophical ’ items of professional relevance. Laboratory medicine is now at the forefront of understanding and implementing the products of the ‘ omics ’ revolution. To date the unravelling of the structure of the human genome has led to a massive increase of knowledge and understanding of the basis of human disease. New diagnostics are being developed from this knowledge but it is taking a long time for these diagnostics to find their way into routine clinical practice. There is a growing recognition that Translational Research is an important part of this journey as new diagnostics require rigorous clinical as well as technical validation against the high standards that arise from the introduction of evidence-based laboratory medicine. Meeting the regulatory requirements for a new diagnostic method is demanding of time and resource and so manufacturers have to pay careful attention to the likely cost effectiveness of any

A survey of patients’ views from eight European countries of interpretive support from Specialists in Laboratory Medicine

Abstract Background: There is increasing interest in direct patient engagement including receiving their laboratory medicine results. We previously established an appetite for Specialists in Laboratory Medicine to support patients in understanding results. The aim of this study was to establish whether patients agreed with such an approach, determined through surveying views in eight European countries. Methods: A standardized five-question survey was administered across eight European countries to a total of 1084 individuals attending medical outpatient clinics, with 100 patients each in Poland, Serbia, Netherlands, Turkey and Czech Republic, 101 in Estonia, 116 in Denmark and 367 in Norway. The responses across countries were compared using the chi-square test (p<0.05). Results: Patients wanting their results ranged from 50% to 94% (mean 65%) of those responding positively, a mean of 72% wanted additional information with their results; direct receipt was preferred over referral to a website. Specialists in Laboratory Medicine providing such information were acceptable to a mean of 62% of those respondents wishing their results; in countries where payment was possible, there was little interest in making additional payment for such a service. Conclusions: A clear proportion of patients are interested in receiving their laboratory medicine results, the majority with explanatory notes; a role for Specialists in Laboratory Medicine is acceptable and raises the potential for direct engagement by such specialists with patients offering a new paradigm for the provision of laboratory medicine activities.

Making test results more easily understood by patients

O’Kane and colleagues ask whether patients can use test results effectively if they have direct access to these results.1 The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) established a working group on patient focused laboratory medicine that has …

Wrong biochemistry results

Editor—In their editorial Ismail and Barth discuss the possibility of getting wrong biochemistry results, particularly when immunoassays are done.1 Laboratories try to detect these problems and provide an accurate, clinically relevant result. But the large number of assays done has resulted in widespread reliance on automation, particularly for hormones, and the “one size fits all” approach inherent in this makes the likelihood of inaccurate results quite high. What is needed is fit-for-purpose assays on these automated platforms. We are aware, though, of the problems that this may present: we have experienced difficulty in persuading a company that the female testosterone values that its machine produces are analytically incorrect and may lead to inappropriate clinical action if preceded by an oestradiol assay (table). The fact that we elicited similar findings from other centres through a computer mailbase and added this weight of evidence to ours did not matter to the company or, worryingly, to the Medical Devices Agency. Until companies recognise that, in a clinical governance setting, no-blame reporting is constructive criticism requiring positive action, then inappropriate interventions will continue to affect patients. More critical oversight of analysis and its clinical implications by the Medical Devices Agency is vital. We need confidence that any problem will be addressed either cooperatively or by effective monitoring.

Wrong biochemistry results : Companies and Medical Devices Agency must act to prevent wrong results

Editor—In their editorial Ismail and Barth discuss the possibility of getting wrong biochemistry results, particularly when immunoassays are done.1 Laboratories try to detect these problems and provide an accurate, clinically relevant result. But the large number of assays done has resulted in widespread reliance on automation, particularly for hormones, and the “one size fits all” approach inherent in this makes the likelihood of inaccurate results quite high. What is needed is fit-for-purpose assays on these automated platforms. We are aware, though, of the problems that this may present: we have experienced difficulty in persuading a company that the female testosterone values that its machine produces are analytically incorrect and may lead to inappropriate clinical action if preceded by an oestradiol assay (table). The fact that we elicited similar findings from other centres through a computer mailbase and added this weight of evidence to ours did not matter to the company or, worryingly, to the Medical Devices Agency. Until companies recognise that, in a clinical governance setting, no-blame reporting is constructive criticism requiring positive action, then inappropriate interventions will continue to affect patients. More critical oversight of analysis and its clinical implications by the Medical Devices Agency is vital. We need confidence that any problem will be addressed either cooperatively or by effective monitoring.