Clinical Biochemists Research Articles

Laboratory Medicine Management: Leadership Skills for Effective Laboratory.

SummaryForum of the European Societies of Clinical Chemistry (FESCC) decided that the FESCC Symposium for Balkan Region would be held each year in Belgrade and organized by the Society of Medical Biochemists of Serbia and Montenegro (SMBSM). Professor Victor Blaton, at the time President of the FESCC, supported the organization of the Symposium. Purpose of these Symposia has been to educate clinical biochemists from Balkan region to improve management, leadership skills for effective laboratories. As a result of these decision twelve symposia have been organized thus far very successfully. Here the most important Symposium topics will be reviewed. Also, the 13th EFLM Symposium for Balkan Region under the title »Laboratory Medicine Management: Leadership Skills for Effective Laboratory« (Belgrade, September 2017) is organized by EFLM and SMBS under the Auspices of the International Federation of Clinical Chemistry (IFCC), Ministry of Education, Science and Technological Development of Serbia and Ministry of Health of Serbia with participation of the European and domestic specialists in field of Laboratory Medicine.

Medical Biochemistry as Subdiscipline of Laboratory Medicine in Serbia.

SummaryMedical biochemistry is the usual name for clinical biochemistry or clinical chemistry in Serbia, and medical biochemist is the official name for the clinical chemist (or clinical biochemist). This is the largest sub-discipline of the laboratory medicine in Serbia. It includes all aspects of clinical chemistry, and also laboratory hematology with coagulation, immunology, etc. Medical biochemistry laboratories in Serbia and medical biochemists as a profession are part of Health Care System and their activities are regulated through: the Health Care Law and rules issued by the Chamber of Medical Biochemists of Serbia. The first continuous and organized education for Medical Biochemists (Clinical Chemists) in Serbia dates from 1945, when the Department of Medical Biochemistry was established at the Pharmaceutical Faculty in Belgrade. In 1987 at the same Faculty a five years undergraduate study program was established, educating Medical Biochemists under a special program. Since the academic year 2006/2007 the new five year undergraduate (according to Bologna Declaration) and four-year postgraduate program according to EC4 European Syllabus for Postgraduate Training in Clinical Chemistry and Laboratory Medicine has been established. The Ministry of Education and Ministry of Public Health accredited these programs. There are four requirements for practicing medical biochemistry in the Health Care System: University Diploma of the Faculty of Pharmacy (Study of Medical Biochemistry), successful completion of the professional exam at the Ministry of Health after completion of one additional year of obligatory practical training in the medical biochemistry laboratories, membership in the Serbian Chamber of Medical Biochemists and licence for skilled work issued by the Serbian Chamber of Medical Biochemists. In order to present laboratory medical biochemistry practice in Serbia this paper will be focused on the following: Serbian national legislation, healthcare services organization, sub-disciplines of laboratory medicine and medical biochemistry as the most significant, education in medical biochemistry, conditions for professional practice in medical biochemistry, continuous quality improvement, and accreditation. Serbian healthcare is based on fundamental principles of universal health coverage and solidarity between all citizens.

Hemoglobinopathies/thalassemias: Why clinical biochemists need to know about them

The clinical catchment area for the Metabolic service at the Women's and Children's Hospital in Adelaide, South Australia, covers nearly 2.5 million km2. Care of children with metabolic disorders in these remote areas is assisted from Adelaide, and at times, using plasma ammonia results from laboratories up to 3000 km away. There are seven different platforms measuring plasma ammonia within this vast clinical catchment area. Hence, a correlation study was conducted to examine the relationship between plasma ammonia results from the seven different platforms in use throughout central Australia.Multiple aliquots of plasma from remainder EDTA samples for haematological investigations were frozen. Samples were then dispatched on dry ice to the laboratories being correlated. At an agreed date and time correlation samples were thawed and plasma ammonia measured.Passing-Bablok regression analysis showed slopes ranging from 1.00 to 1.10 and y-intercepts ranging from − 10 μmol/L to 1 μmol/L.Despite the absence of a reference method or reference material and troublesome pre-analytical effects in ammonia measurement, plasma ammonia results from the different platforms in general compare well. The study also demonstrates that samples for ammonia measurement can be transported over great distances and still correlate well. Furthermore, a common reference interval for plasma ammonia may be a possibility.

Uptake of recommended common reference intervals for chemical pathology in Australia.

Background Reference intervals are a vital part of reporting numerical pathology results. It is known, however, that variation in reference intervals between laboratories is common, even when analytical methods support common reference intervals. In response to this, in Australia, the Australasian Association of Clinical Biochemists together with the Royal College of Pathologists of Australasia published in 2014 a set of recommended common reference intervals for 11 common serum analytes (sodium, potassium, chloride, bicarbonate, creatinine male, creatinine female, calcium, calcium adjusted for albumin, phosphate, magnesium, lactate dehydrogenase, alkaline phosphatase and total protein). Methods Uptake of recommended common reference intervals in Australian laboratories was assessed using data from four annual cycles of the RCPAQAP reference intervals external quality assurance programme. Results Over three years, from 2013 to 2016, the use of the recommended upper and lower reference limits has increased from 40% to 83%. Nearly half of the intervals in use by enrolled laboratories in 2016 have been changed in this time period, indicating an active response to the guidelines. Conclusions These data support the activities of the Australasian Association of Clinical Biochemists and Royal College of Pathologists of Australasia in demonstrating a change in laboratory behaviour to reduce unnecessary variation in reference intervals and thus provide a consistent message to doctor and patients irrespective of the laboratory used.

Application of Sigma Metrics and Performance Comparison Between Two Biochemistry Analyser and a Blood Gas Analyser for the Determination of Electrolytes.

Electrolytes have a narrow range of biological variation and small changes are clinically significant. It is important to select the best method for clinical decision making and patient monitoring in the emergency room. The sigma metrics model provides an objective method to evaluate the performance of a method. To calculate sigma metrics for electrolytes measured with one arterial blood gas analyser including two auto-analysers that use different technologies. To identify the best approach for electrolyte monitoring in an emergency setting and the context of routine emergency room workflow. The Coefficient of Variation (CV) was determined from Internal Quality Control (IQC). Data was measured from July 2015 to January 2016 for all three analysers. The records of KBUD external quality data (Association of Clinical Biochemists, Istanbul, Turkey) for both Mindray BS-2000M analyser (Mindray, Shenzhen, China) and Architect C16000 (Abbott Diagnostics, Abbott Park, IL) and MLE clinical laboratory evaluation program (Washington, DC, USA) for Radiometer ABL 700 (Radiometer Trading, Copenhagen, Denmark) during the study period were used to determine the bias. The calculated average sigma values for sodium (-1.1), potassium (3.3), and chloride (0.06) were with the Radiometer ABL700. All calculated sigma values were better than the auto-analysers. The sigma values obtained from all analysers suggest that running more controls and increasing the calibration frequency for electrolytes is necessary for quality assurance.

Abstracts of 43rd National Conference of Association of Clinical Biochemists of India (ACBICON 2016)

Abstracts of 43rd National Conference of Association of Clinical Biochemists of India (ACBICON 2016)

The Royal Postgraduate Medical Centre, Hammersmith Hospital, London

Ball-pen sketch of Hammersmith Hospital in 1968 Recent photo of Hammersmith Hospital When I was repacking old books, documents, and other stored objects for a major renovation of my house, I found some ball-pen sketches and watercolor paintings I did during my first trip to the United Kingdom. In 1967, after completing my PhD, I was the first clinical biochemist from Singapore's Ministry of Health Department of Pathology to be awarded a Commonwealth Fellowship for further professional training and acquisition of the latest knowledge in the field at several well-known British medical centers, namely: the Royal Postgraduate Medical School in London, the Queen Elizabeth Hospital at the University of Birmingham, …

Analytical Evaluation of Hemochroma POC Haemoglobin Reader

Background: Good laboratory practice requires that Clinical laboratories verifies the performance claims of a method before results generated by such an instrument can be used for decisions about patient care. Analytical evaluation of a new point of care methods should be done before its introduction into the routine use in order to confirm its declared analytical performance specifications. Objective: To evaluate the degree of analytical accuracy of the Hemochroma POC haemoglobin reader relative to the Coulter AcT hematology analyzer. Study design and setting: A comparative study, conducted at the University of Nairobi, Thematic unit of Clinical Chemistry Laboratory and the Department of Obstetrics and Gynecology. Materials and methods: The evaluation was performed according to the guidelines of the European Committee for Clinical Laboratory Standards (ECCLS) and the guidelines on the evaluation of point of care testing instruments by the Australian Association of Clinical Biochemists (AACB). The analytical ability of Hemochroma POC reader (Boditech Med Inc.) to determine the levels of hemoglobin (Hb) according to the manufacturers claimed accuracy levels was evaluated using the routine 'comparative' method, Coulter AcT (Beckman Coulter Inc, Fulerton, CA 92835). Results: Hemochroma POC hemoglobin reader yielded a correlation coefficient of 0.976 against the Coulter AcT hematology analyzer. The slope and the y-axis intercept as well as their 95% confidence intervals were 0.990 (95% CI 0.891 to 1.020) and 0.003 (95% CI -0.151 to 1.439), respectively.

Abstracts of 42nd National Conference of Association of Clinical Biochemists of India (ACBICON 2015)

Abstracts of 42nd National Conference of Association of Clinical Biochemists of India (ACBICON 2015)

Reporting unit size and measurement uncertainty: current Australian practice in clinical chemistry and haematology

In this study we aimed to compare the reporting unit size used by Australian laboratories for routine chemistry and haematology tests to the unit size used by learned authorities and in standard laboratory textbooks and to the justified unit size based on measurement uncertainty (MU) estimates from quality assurance program data. MU was determined from Royal College of Pathologists of Australasia (RCPA) - Australasian Association of Clinical Biochemists (AACB) and RCPA Haematology Quality Assurance Program survey reports. The reporting unit size implicitly suggested in authoritative textbooks, the RCPA Manual, and the General Serum Chemistry program itself was noted. We also used published data on Australian laboratory practices.The best performing laboratories could justify their chemistry unit size for 55% of analytes while comparable figures for the 50% and 90% laboratories were 14% and 8%, respectively. Reporting unit size was justifiable for all laboratories for red cell count, >50% for haemoglobin but only the top 10% for haematocrit. Few, if any, could justify their mean cell volume (MCV) and mean cell haemoglobin concentration (MCHC) reporting unit sizes.The reporting unit size used by many laboratories is not justified by present analytical performance. Using MU estimates to determine the reporting interval for quantitative laboratory results ensures reporting practices match local analytical performance and recognises the inherent error of the measurement process.

Evaluation of the effect of clinical validation of out of hours critical laboratory results.

The aim of the study was to review the clinical validation process of out of hours critical biochemistry results by a clinical biochemist and its effect on primary care services. A prospective study was conducted of all critical results for primary care patients who were analysed out of hours. The nine-month study period was conducted between June 2013 and February 2014. The data collected include patients' age, clinical details, critical results and the urgency of result communicated. The patients' subsequent attendance rate at the emergency department in the local hospital was reviewed. A total of 311 out of hours critical results were identified in the laboratory. After clinical validation, 110 (35.4%) results were telephoned urgently and 155 (49.8%) results were deferred to the next day. Forty-six (14.8%) results were not telephoned. Following the urgent result communication, 53/110 (48.2%) patients attended the hospital emergency department within 24 h and 17/110 (15.5%) had their repeat blood test by their general practitioner surgery within 48 h. When the result was telephoned during working hours the next day, only 15/155 (9.7%) attended the hospital acute services within 48 h and 16/155 (10.3%) had repeat blood test at their general practitioner surgery. In our practice, the clinical validation of out of hours critical results by a clinical biochemist is associated with a reduction in the number of results telephoned when compared against the critical limits list recommended by the Royal College of Pathologists and may focus out of hours clinical activity on more suitable patients.

May CTC technologies promote better cancer management?

In the case of cancer, death is usually not due to the primary tumor itself but due to dissemination. Analysis of the circulating tumor cells (CTCs), i.e., cells responsible for a formation of metastases, should provide information useful for the management of cancer patients, fulfilling the objectives of predictive, preventive, and personalized medicine (PPPM). Despite promising results, the decisions on stage of disease and how to guide the adjuvant treatment still do not include results of CTC assessment. We want to describe two major reasons why the recent diagnostic value of CTC analysis is not sufficient for clinical use. The first reason arises from the biological nature of the tumor itself and the second reason is associated with an interdisciplinary status of CTC diagnostics in the sense that it is neither a theme purely for pathologists nor for haemato-oncologists nor clinical biochemists. We anticipate that there are at least three areas where CTCs can be useful for clinical practice. The first is monitoring of treatment efficacy of cancer patients. The second is a molecular characterization of captured CTCs for targeted treatment, and the third is a cultivation of captured CTCs for drug sensitivity testing. All of these approaches allow researchers recognize and respond to changes of phenotype of cancer cells during disease progression and introduce PPPM into clinical practice.

Quantitative Assay of Immunoglobulin Free Light Chains (FLC): Evaluation of Monoclonal Versus Polyclonal Antibody and Immunoturbidimetric Versus Immunonephelometric Detection Technology

Introduction. It has been rarely reported that a laboratory test introduced so rapid and radical changes in diagnostic algorithm as is the case with the quantitative assay of free light chains of immunoglobulins (FLC) in serum and its role in the diagnostic algorithm of monoclonal gammopathies. Since the first description of immunoassay in year 2001 until today, new evidence has continuously been reported in the literature that confirm the clinical usefulness of this test in diagnosis, monitoring and prognosis of monoclonal plasma-proliferative diseases, especially diseases of light chains such as primary amyloidosis, light chain deposition disease (LCDD) or light chain multiple myeloma (LCMM) and nonsecretory multiple myeloma (NSMM). Recently, a commercial test has become available on the market that uses polyclonal antibodies to specific epitopes of free light chains which are hidden in the intact immunoglobulin molecules. In 2011, a commercial immunoassay was launched on the market that uses monoclonal instead of polyclonal antibodies, reducing the variability between different series of reagents and controlling excess antigen in the sample.Aim. The aim of this study was to evaluate monoclonal versus polyclonal antibody and immunoturbidimetric versus immunonephelometric detection technology. Does different detection tehnology – besides different used antibody – contribute to greater variability in results?Method. In this study we compared results of 40 samples measured with polyclonal antibody (The Binding Site Ltd., Birmingham, UK) and monoclonal antibody (N Latex FLC, Siemens Healthcare Diagnostics, Marburg, Germany). In other 40 samples we compared results achieved with different antibodies and different analytical platforms (Siemens Nephelometer with Roche Cobas). Results were statistically analyzed using MedCalc software.Results. Results are shown in Table 1. Comparing all results, it is evident that there is at least proportional error when comparing different antibodies and different analytical systems. Although it is known that immunoturbidimetry is less sensitive than immunonephelometric method, greater discrepancies in results were not found. When we categorized patients as positive and negative according to manufacturer’s reference interval for kf/lf ratio, agreement between groups with different antibody and same detection technology was 63% (weighted kappa 0.30). Agreement between groups with different antibodies and different detection technology was 86% (weighted kappa 0.22). Although we have not measured the same samples when testing antibody and analytical platform, the selected analytical platform has, according to our results, no additional impact on the variability of results.Abstract 5680. Table 1Comparison of FLC results using different antibody and different analytical platformsMethodFLC kappa polyclonal Ab Nephelometer SiemensFLC kappa monoclonal Ab Nephelometer SiemensFLC lambda polyclonal Ab Nephelometer SiemensFLC lambda monoclonal Ab Nephelometer SiemensResults (min-max)6.59-5210.006.34-1600.001.67-3010.001.00-1600.00Passing-Bablok fitintercept (95% Cl)8.2442.9255 to 14.92491.0945-1.5910 to 5.5631slope (95% Cl)0.5950.4564 to 0.78521.87981.5336 to 2.1045Correlation rs (p<0.0001)0.9110.887MethodFLC kappa polyclonal Ab Cobas RocheFLC kappa monoclonal Ab Nephelometer SiemensFLC lambda polyclonal Ab Cobas RocheFLC lambda monoclonal Ab Nephelometer SiemensResults (min-max)2.40-453.201.10-342.002.30-452.1010.30-301.20Passing-Bablok fitintercept (95% Cl)2.622-3.8207 to 9.30230.1585-3.9731 to 4.5892slope (95% Cl)1.51.2972 to 1.99330.74160.6174 to 0.8708Correlation rs (p<0.0001)0.8730.929Conclusion. Physicians and especially clinical biochemists must be aware of the technical shortcomings of this test, such as the variability between different series (lots) reagents, non-linearity, unreliable detection of excess antigen and overestimation of FLC concentrations due to nonspecific interference or polymerization.Although initial results are not discouraging, it will be necessary to collect much more evidence, especially bearing in mind that use of monoclonal antibodies along with advantages has certain disadvantages. In the future, it will probably be necessary to incorporate into the guidelines a recommendation to report the method used, like for other tumor markers. [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Abstracts of 41st National Conference of Association of Clinical Biochemists of India (ACBICON 2014)

Abstracts of 41st National Conference of Association of Clinical Biochemists of India (ACBICON 2014)

Lab tests online Australasia

Lab Tests Online Australasia is a patient-centred website providing information on pathology testing (http://www.labtestsonline. org.au/). There is also an app that can be downloaded. While the primary purpose of this website is to provide information to patients, caregivers, and their families, it is also used by general practitioners, nurses and medical students to gain up to date information on diagnostic testing. It is a peer-reviewed, noncommercial entity providing information on tests, sample collection and clinical associations. The site is managed by the Australasian Association of Clinical Biochemists (AACB) with support from the Royal College of Pathologists of Australasia (RCPA) and a funding grant from the Quality Use of Pathology Program (Commonwealth Department of Health and Ageing). The site is accredited by HONcode, which is an ethical standard aimed at offering quality health information. As part of this accreditation the site is fully reviewed every 3 years to ensure content is current and correct. For immunology, this is currently performed by Dr Daman Langguth who has been instrumental in updating and modifying content for the Australian market.

The monitoring of diabetes mellitus

Changes in clinical practice are often preceded by the gathering of evidence which can take several years. Diabetes mellitus is a prime example of how its management has changed with a mix of advances in laboratory medicine and technology. I was first introduced to the world of the Maillard reaction, Amadori rearrangement and Schiff bases in the early 1980s while working with Professor Sir George Alberti when he handed me a paper on nonenzymatic glycosylation of proteins and their use in diabetes control. Fast forward to the late 1980s when the University of Manchester Department of Medicine at Manchester Royal Infirmary moved from World War II hutments to a new building. The departmental library moved too, and volumes lay haphazardly on shelves. Professor Peter Adams, turning to me, a research fellow, said ‘You look a bit spare, how about sorting out this library?’ Among the journal volumes, there was a historical treasure trove of publications from famous names, but it was here that I first saw a complete collection of the Annals of Clinical Biochemistry starting from volume one. It belonged to the late Jeff Lumb who produced seminal works on vitamin D and calcium metabolism. It was interesting to see the current Annals evolve from the Proceedings of the Association of Clinical Biochemist meetings around the country. The monitoring of diabetes was initially based on urine glucose testing. RD Lawrence, the well-known Chemical Pathologist and Physician, in his 1937 edition of his book gave details of the best times to test for urine glucose and suggested that the Benedict’s test was better than using Fehling’s reagent. For general practitioners, he recommended tests such as the fermentation test for sugars and an iodine test for starch to determine suitability of ‘diabetic’ foods. By 1941, tablets were available to test for urine sugar and over time these morphed into the present day urine dipsticks. In 1962, a semiquantitative method for blood glucose was available. By the 1970s, self-monitoring of blood glucose (SMBG) was being developed and demonstrated to improve glycaemic control. In parallel to these developments, a new way to monitor glycaemic control was being developed. It started very much with Samuel Rahbar’s chance discovery of an unidentified band on electrophoresis in blood from a 67-year-old diabetic woman when he was working on a project looking at haemoglobin variants in Iran. He published his findings in a sister clinical biochemistry journal and confirmed his results in a larger series in the USA. Glycosylated haemoglobin A1c (HbA1c) was first described in 1958 by Huisman et al. and was characterized later in 1966, but the diabetes connection was only confirmed by Rahbar in 1969. Further work by Koenig et al. established the clinical utility of HbA1c through a series of papers in the mid 1970s. In the early 1990s, the Diabetes Control and Complications Trial confirmed the utility of HbA1c in type 1 diabetes and in the late 1990s, the United Kingdom Prospective Diabetes Study demonstrated

Antibody interference in immunoassay: know your enemy

Antibody interference in clinical immunoassay continues to alarm clinicians, confound immunoassay manufacturers and challenge clinical biochemists. Every year sees the publication of case studies and articles describing situations where immunoassays have returned incorrect results and the adverse effect this can have on patient care. This month’s edition of the Annals contains three such articles. Essentially, antibody-related immunoassay interference is caused by circulating antibodies that can bind to either the analyte or the immunoassay reagents potentially generating incorrect results (see ref. for a comprehensive review). The incidence of assay interference is difficult to establish and is both assay and analyte dependent. Thyroglobulin immunoassay is notoriously susceptible to interference; results from the method comparison study cited here suggest an incidence of 12%. For thyroid-stimulating hormone (TSH) immunoassay, the incidence of 0.6% using polyethylene glycol (PEG) precipitation and gel filtration chromatography (GFC) studies is equally disturbing, given the widespread use of this assay as a ‘front-line’ test for thyroid dysfunction. This is not dissimilar to published values. While the mechanism of antibody interference is often considered academic, once established it can be used as a basis to improve assay design or guide the selection of alternative methods. Interfering antibodies can be specific to the assay reagents (anti-animal antibodies) or the analyte (autoantibodies if to an endogenous molecule). Weak polyspecific antibodies (heterophilic antibodies) are also a common cause of antibody interference as, in accordance with Murphy’s law, they too can have affinity for analytes or assay reagents. Falsely increased results can be generated with competitive immunoassays by antibodies which sequester tracer or block the assay antibody. Crosslinking of capture and detection antibody in twosite assays also leads to false-positive results, and this is the likely mechanism for the false-positive adrenocorticotrophic hormone (ACTH) result described here. Negative interference is usually caused by blocking the binding of either the capture or detection antibody in two-site assays, which is a likely cause of thyroglobulin assay interference. Falsely low results in competitive assays are rare, but have been described; in this case the interfering antibody must prevent displacement of the tracer from the detection antibody. Anti-analyte antibodies usually present as falsely elevated results as the analyte:antibody complex can be immunoreactive, but not biologically active. The clearance of the analyte:antibody complex is often delayed compounding the effect. These are widely referred to as ‘macro-analytes’; this is a plausible mechanism for the falsely elevated TSH cases described here. Considerable effort has gone into minimizing the risk of antibody interference and most commercial immunoassay kits contain reagents to address this. Anti-animal antibodies can be specifically targeted using excess animal immunoglobulin without affinity for the analyte in question. Heterophilic blocking agents are more mysterious, as their composition is commercially sensitive, but these can be antibody fragments designed to specifically block the invariant tail region (Fc) region of antibody reagents, where heterophiles usually bind. The use of antigen binding (FAb) fragments, rather than intact antibodies, also protects against heterophile interference using similar logic. There are several tools that laboratories can use to confirm the presence of assay interference.

Mass or molar? Recommendations for reporting concentrations of therapeutic drugs

A working party (WP) from the Australasian Association of Clinical Biochemists, Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, Royal College of Pathologists of Australasia and Royal Australasian College of Physicians recommends the following: *mass units should be used for reporting therapeutic drug concentrations in Australia and New Zealand; and the litre (L) should be used as the denominator when expressing concentration. Examples of these units are mg/L and μg/L Exceptions to these principles include: *drugs for which there is current uniformity of reporting and supporting information using molar units, notably lithium (mmol/L) and methotrexate (μmol/L); *drugs that are also present as endogenous substances, where the units used routinely should continue to be used. This applies to many substances, including minerals (eg, iron; μmol/L), vitamins (eg, vitamin D; nmol/L) and hormones (eg, thyroxine; pmol/L). *drugs for which the denominator is not a 198 of fluid and there is international uniformity of reporting (eg, thiopurine metabolites; per 109 red blood cells). These recommendations relate to drugs that are used therapeutically, whether measured for therapeutic drug monitoring purposes or for assessment of overdose. Other substances, such as drugs of misuse, heavy metals or environmental toxins, were not considered by the WP and are thus not covered by this document. These recommendations should also be applied to other supporting documentation such as published guidelines, journal articles and websites. The implementation of these recommendations in New Zealand is subject to local confirmation.

Experience with a large point of care testing network

Introduction PoCT is an important enabler of evidence-based cardiac care allowing safe risk stratification and management of patients across country hospitals. Success of a large network relies on good communication, user-friendly instructions, effective IT, flexible training programs and good support systems. Methods The Integrated Cardiovascular Clinical Network Country Health SA (iCCnet CHSA) provides face to face and videoconferencing training, online education and competencies for PoCT operators. Online resources are located on the iCCnet CHSA website (www.iccnetsa.org.au) and 24/7 technical support is provided to PoCT operators. Results iCC net CHSA supports PoCT across country hospitals in South Australia. PoCT is managed by clinical network scientists complying with recommendations set by professional organisations such as the Australasian Association of Clinical Biochemists. They ensure all hospitals are involved in quality programs and have access to training when required. Because of staff resources across country, a variety of options for training PoCT operators are provided, ensuring it is accessible to all staff when convenient. Conclusions iCCnet CHSA removes the barriers to access education, training and support to allow the operation of PoCT within a quality framework in the management of cardiovascular disease. PoCT has been integral component to the improved cardiac outcomes reported by iCCnet CHSA. PoCT is an important enabler of evidence-based cardiac care allowing safe risk stratification and management of patients across country hospitals. Success of a large network relies on good communication, user-friendly instructions, effective IT, flexible training programs and good support systems. The Integrated Cardiovascular Clinical Network Country Health SA (iCCnet CHSA) provides face to face and videoconferencing training, online education and competencies for PoCT operators. Online resources are located on the iCCnet CHSA website (www.iccnetsa.org.au) and 24/7 technical support is provided to PoCT operators. iCC net CHSA supports PoCT across country hospitals in South Australia. PoCT is managed by clinical network scientists complying with recommendations set by professional organisations such as the Australasian Association of Clinical Biochemists. They ensure all hospitals are involved in quality programs and have access to training when required. Because of staff resources across country, a variety of options for training PoCT operators are provided, ensuring it is accessible to all staff when convenient. iCCnet CHSA removes the barriers to access education, training and support to allow the operation of PoCT within a quality framework in the management of cardiovascular disease. PoCT has been integral component to the improved cardiac outcomes reported by iCCnet CHSA.

Paediatric reference intervals

Worldwide there appear to be two main approaches to addressing the gap in paediatric biochemistry reference intervals: (1) large scale, government-funded reference interval studies based on recruiting healthy children, and (2) ‘harmonisation' to achieve common reference intervals (CRI). The first are national paediatric-focused reference interval studies, including CALIPER study (Canadian Laboratory Initiative on Pediatric Reference Intervals,), KiGGS (The German Health Interview and Examination Survey for Children and Adolescents), NORICHILD (Scandinavian Initiative for the Establishment of Pediatric Reference Intervals) and CHILDx (Children's Health Improvement through Laboratory Diagnostics) by ARUP Laboratories and the University of Utah, NIH. The second approach is a national or regional group undertaking the task of defining common reference intervals using a multicentre study design. The RIs are determined via collaboration of laboratories from different regions that use analytical methods traceable to a reference method. UK Harmony, ARQAG (Auckland Regional Quality Assurance Group) and SIQAG (South Island Quality Assurance Group) have taken this approach for adult and paediatric biochemistry RIs. This is also the approach recommended by the Australian Association of Clinical Biochemists (AACB) Paediatric Special Interest Group. Unfortunately there is no perfect solution; both approaches have obstacles that hinder the implementation by laboratories. Recent data from CALIPER suggest transference of RIs to all major instrument platforms may be possible based on their population studies