Association Of Clinical Biochemists Research Articles

Standardisation of adjusted calcium equation: the UK approach—a narrative review

Background and Objective: Adjusted serum calcium in the UK has, since the 1970s, almost exclusively been calculated in relation to the serum albumin level measured on the same specimen. Since 1973 various adjustment equations have been derived and reported in the literature. More recently, laboratory information systems have allowed laboratories easily to derive their own adjustment equations. Both Pathology Harmony UK and The Association for Clinical Biochemistry and Laboratory Medicine (ACB) have proposed similar protocols for laboratories to follow to achieve this aim. The objective of this review is to investigate the various strategies for adjustment of calcium and compare their performance for assessment of physiological calcium status against actual (unadjusted) and ionised calcium.

EP-373 Appropriate requesting of tumor marker, CEA, at a district hospital in Ireland: An audit cycle to improve practice

Abstract Aims Tumor markers play an important role in oncology and the appropriate requesting of tumor marker tests are facilitated by national and international guidelines, inappropriate use increases both the laboratory workload and overall cost of management. Our aim was to assess our practice against the ACBI (Association of Clinical Biochemists in Ireland) guidelines for carcinoembryonic antigen (CEA) and conduct teaching sessions to improve practice. Methods 1st cycle: All carcinoembryonic antigen (CEA) tests ordered in the hospital between the 1st to 31st of October 2020 were obtained through the HSE Online Lab Web Inquiry System, files were then reviewed for indications. Results from the initial audit were presented to the department and two separate teaching sessions were conducted to educate on the guidelines. 2nd cycle: All CEA test ordered from 1st January to 28th February 2021 were obtained, re-audited and results were compared. Results 76% of the tests ordered by General Surgery in the second cycle were appropriately ordered and incorrectly ordered tests decreased from 35.7% to 23.8%. Conclusions Through the process of this audit an improvement was seen in practice of the department. More tests ordered adhered to indications in guidelines.

Asian Conference on Biomedical Research and Laboratory Medicine 2021

Asian Conference on Biomedical Research and Laboratory Medicine was organized by three associations: Malaysian Association of Clinical Biochemists (MACB), Association of Scientific Officers Ministry of Health (ASOMH), and Malaysian Biomedical Science Association (MyBIOMED). The conference was held on 24th-25th August 2021 and a workshop on 26th August 2021 through Webex Webinar Platform with the theme of “Revolutionising laboratory medicine through research and innovation”. This conference aimed to bring together leading academic, scientists, laboratory medical scientists, pathologists, researchers, and research scholars to exchange and share their experiences and research results about all aspects of laboratory medicine and health sciences. There were a total of almost 500 participants registered and over 100 abstracts submitted for this conference.

A UK national audit of the laboratory investigation of phaeochromocytoma and paraganglioma.

Phaeochromocytomas and paragangliomas (PPGL) are catecholamine secreting tumours associated with significant morbidity and mortality. Timely diagnosis and management are essential. A range of laboratory tests can be utilised in the investigation of PPGL. There is scope for significant variation in practice between centres. We aimed to investigate how the laboratory investigation of PPGL is performed in laboratories across the United Kingdom. A questionnaire consisting of 21 questions was circulated to Clinical Biochemistry laboratories in the United Kingdom via the Association for Clinical Biochemistry and Laboratory Medicine office. The survey was designed to allow audit against Endocrine Society Guidelines on the Investigation and Management of PPGL and to obtain information on other important aspects not included in these guidelines. Responses were received from 58 laboratories and the data were compiled. The majority of laboratories use either urine or plasma metanephrines in first-line testing for PPGL, although a number of different combinations of biochemistry tests are utilised in different centres. All laboratories measuring metanephrines or catecholamines in-house use LC or LC-MS/MS methods. There are some marked differences between laboratories in urine metanephrines reference ranges used and sample requirements. There is evidence of good practice in UK laboratories (as assessed against Endocrine Society Guidelines) such as widespread use of urine/plasma metanephrines and appropriate analytical methodologies used. However, there is also evidence of variations in practice in some areas that should be addressed.

Reflex and reflective testing practice in Clinical Biochemistry in the United Kingdom - a national survey.

Background/aims The addition of further tests to patient samples, whether by reflex (automated) methods or reflectively after result review, remains an important function of the diagnostic laboratory. This can assist clinicians with interpretation of results and aid further management. We aimed to investigate how this is performed within Clinical Biochemistry laboratories across the United Kingdom (UK). Methods A questionnaire, consisting of 16 clinical scenarios, was circulated to Clinical Biochemistry laboratories across the UK via the Association for Clinical Biochemistry and Laboratory Medicine (ACB) office. The survey sought to examine opinion on what tests are considered reflex and reflective, which staff members are involved in addition of further tests, whether clinicians are contacted and how abnormal results are handled. Results Responses were received from 74 laboratories, and data were compiled for each scenario surveyed. The majority of laboratories are adding calcium and magnesium, reflectively, to confirm hyperkalaemia or hypocalcaemia, and a number of additional endocrine tests are also commonly performed in particular scenarios. However, there are variations in what is regarded as reflex and reflective testing, in how this testing is conducted within the laboratory and in the level of communication with the requesting clinician. Discussion We present the consensus views of the survey participants for a number of commonly used additional tests within Clinical Biochemistry and a discussion on current reflex and reflective testing practice based on the survey results and evidence, where it exists. There is a need for harmonization and national guidance in this area.

Abstracts of 45th National Conference of Association of Clinical Biochemists of India (ACBICON 2018)

Abstracts of 45th National Conference of Association of Clinical Biochemists of India (ACBICON 2018)

Guidelines on the management of abnormal liver blood tests

These updated guidelines on the management of abnormal liver blood tests have been commissioned by the Clinical Services and Standards Committee (CSSC) of the British Society of Gastroenterology (BSG) under...

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)

Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis.

Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators. The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. There are a variety of data collection methods, including audit, manual recording processes, incident reporting mechanisms and laboratory information systems. Quality management processes such as benchmarking, statistical process control, Pareto analysis and failure mode and effect analysis can be used to review data and should be incorporated into clinical governance mechanisms. In this paper, The Association for Clinical Biochemistry and Laboratory Medicine PreAnalytical Specialist Interest Group review the various data collection methods available. Our recommendation is the use of the laboratory information management systems as a recording mechanism for preanalytical errors as this provides the easiest and most standardized mechanism of data capture.

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.

Guidelines for laboratory analyses for poisoned patients in the United Kingdom

To enable consistency of investigation and the establishment of best practice standards, consensus guidelines were formulated previously by the UK National Poisons Information Service and the Association for Clinical Biochemistry. These joint guidelines have now been updated to reflect current best practice. The types of laboratory investigation required for poisoned patients are categorized as either (a) essential common laboratory investigations or (b) specific toxicological assays, and also as either (i) common or (ii) specialist or infrequent. Tests in categories (a) and (bi) should be available 24 hours per day, with a maximum turnaround time of 2 h. For the specialist assays, i.e. category (bii), availability and turnaround times have been specified individually. The basis for selection of these times has been clinical utility. The adoption of these guidelines, along with the use of the National Poisons Information Service (0844 8920111) and its online poisons information resource TOXBASE(®) (www.toxbase.org) enable the poisoned patient to receive appropriate, 'best practice' investigations according to their clinical needs and will avoid unnecessary investigations.

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.

Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach

In a time when laboratories are struggling to cope with increasing pressures on their services, and shrinking budgets demand management tools and strategies provide potential solutions. There are a number of areas where the laboratory is being squeezed including increasing workloads, increased costs, reduced revenue, inappropriate tests and changes in how their services are commissioned and delivered. The pathology workload in the UK alone is increasing by an average of 10% every year and must be delivered despite a 20% reduction in pathology funding [ 1 ]. Workload has been increasing due to both increases in appropriate and inappropriate tests. Advances in laboratory technology have allowed multiple testing, more rapid turnaround times and more choice. With the advent of the worldwide web, patients are better informed and become advocates for their own investigations. The population is also getting older with more patients having chronic diseases, which require effective long-term management. Requestors are also more defensive in the way they request for fear of missing a test or a medico-legal consequence. Identifying the appropriate and inappropriate test is a challenge for the laboratory, but this in itself depends upon the perspective of the individual. A standardised approach and definition of an appropriate or inappropriate test is required to allow the laboratories to effectively manage each. In Australia, the National Coalition of Public Pathology Report (2012) presents a matrix that can be used to ascertain whether a request is appropriate or inappropriate, thereby bringing some standardisation to this difficult area [ 2 ]. Therefore, the laboratory must be proactive in effectively managing its workload in order to provide the best service for the patient within the defined constraints. The ideal demand management strategy ensures that the right test is done on the right patient at the right time. It also provides an opportunity to harmonise processes and remove unnecessary waste thereby saving money. A number of demand management solutions are available, which can assist the laboratory and can be grouped into five areas: education, rules aimed at restricting test requests, redesign of request forms, computerised physician order entry (CPOE) and reimbursement models [ 2 ]. Fryer and Smellie have recently published a demand management toolbox to assist laboratories in achieving effective workload management [ 3 ]. One solution that has already showed promise and sustainability are rules aimed at restricting tests based on time between repetitive tests [ 4 , 5 ]. In this issue of the Clinical Chemistry and Laboratory Medicine , Janssens and Wasser discuss an example of this type of intervention, calculating the financial savings realised [ 6 ]. In partnership with hospital physicians “ spare periods ” (periods during which tests were barred) were produced and implemented through the laboratory information and management system (LIMS). Although the savings in this example were relatively low in proportion to their own pathology budget and previously published figures, they indicated that it should still be continued due to the minimum effort required to sustain it. A key step in such a solution is the partnership between the laboratory and the clinician using the service as demonstrated in this paper. What is sometimes lacking is the evidence to support an intervention particularly when barring tests, which from a user ’ s perspective may be thought to be necessary. The provision of and availability of individual tests may differ between laboratories with different demand management rules in place based on local practice and rarely published evidence or practice. To address some of the variance in practice and lack of evidence base, the Clinical Practice Section of the Association for Clinical Biochemistry (ACB) prepared a set of consensus/evidence based recommendations on when a test should be repeated [ 7 ]. The National Minimum Retesting Interval Project used a “ state of the art ” approach to prepare over 100 recommendations in a number of clinical areas [ 8 ]. Invited members working in small groups prepared recommendations, which when complete were then assessed by an independent reviewer before review by a panel of regional representatives. Where evidence

Pathology harmony moves on: progress on implementation in haematology

Pathology harmony moves on: progress on implementation in haematology

Quality assessment, standardization

Background: Although protein electrophoresis of serum (SPEP) and urine (UPEP) specimens is a well-established laboratory technique, the reporting of results using this important method varies considerably between laboratories. The Australasian Association of Clinical Biochemists recognized a need to adopt a standardized approach to reporting SPEP and UPEP by clinical laboratories. Methods: A Working Party considered available data including published literature and clinical studies, together with expert opinion in order to establish optimal reporting practices. A position paper was produced, which was subsequently revised through a consensus process involving scientists and pathologists with expertise in the field throughout Australia and New Zealand. Results: Recommendations for standardized reporting of protein electrophoresis have been produced. These cover analytical requirements: detection systems; serum protein and albumin quantification; fractionation into alpha-1, alpha-2, beta and gamma fractions; paraprotein quantification; urine Bence Jones protein quantification; paraprotein characterization; and laboratory performance, expertise and staffing. The recommendations also include general interpretive commenting and commenting for specimens with paraproteins and small bands together with illustrative examples of reports. Conclusions: Recommendations are provided for standardized reporting of protein electrophoresis in Australia and New Zealand. It is expected that such standardized reporting formats will reduce both variation between laboratories and the risk of misinterpretation of results.

The availability of toxicological analyses for poisoned patients in Ireland

Background. The National Poisons Information Service and the Association of Clinical Biochemists in the United Kingdom published guidelines on laboratory analyses for poisoned patients in 2002. In 2003, U.S. guidelines were prepared by an expert panel of analytical toxicologists and emergency department (ED) physicians. Some professional associations in different countries quote these guidelines but there are no data to support adherence to these recommendations in the medical literature. Objective. To analyze the availability of 15 quantitative laboratory analyses, specifically relating to the management of the poisoned patient, in Ireland. Methods. A questionnaire relating to the provision of toxicological analyses was compiled and distributed to 39 acute care hospital laboratories in Ireland. The availability of 15 quantitative analyses (carbamazepine, carboxyhemoglobin, digoxin, ethanol, ethylene glycol, iron, lithium, methemoglobin, methanol, paracetamol, paraquat, phenobarbital, salicylate, theophylline, and valproic acid), specifically relating to the management of the poisoned patient, was analyzed. The reporting units for these analyses were also collected. The acute care hospitals were sorted into groups according to their number of ED attendances: A) <20,000, B) 20,000–30,000, C) 30,000–40,000, D) 40,000–50,000, and E) >50,000 based on ED activity data for 2008. The median number of assays provided by each hospital group was calculated. Results. The response rate was 100%, allowing complete national data to be ascertained. Hospital laboratories provided a more comprehensive testing service when ED attendances exceeded 30,000 per annum. Sixteen hospital laboratories (41.0%) performed at least 10 of the 15 toxicological investigations. The most widely available assay was paracetamol (74.4%, n = 29) and the least widely available assays were methanol, ethylene glycol, and paraquat (2.6%, n = 1). Only one hospital laboratory provided all 15 analyses. Hospital laboratories in groups A and B carried out a median number of 3/15 assays (range 0–8) and 4/15 assays (range 0–10), respectively. Hospital laboratories where ED attendances exceeded 30,000 per annum carried out a median number of 11/15 toxicological assays (range 1–15). There was a lack of consistency in the reporting units with both molar and mass units used. Conclusion. There is wide availability of toxicological analyses among hospital laboratories in Ireland. Most analyses were provided with 24-h availability. Hospitals with ED attendances in excess of 30,000 provided a more comprehensive laboratory service with respect to the number of analyses performed. The lack of consistency with units used by Irish hospital laboratories could present challenges with the reporting and interpretation of quantitative results. This study could be carried out in other countries to establish what analyses are available for the treatment of poisoned patients.

Creatinine eGFR and all that, an update

The introduction of routine reporting of eGFR is now part of the health landscape in Australia and many countries worldwide. There are well known limitations to this process and it is appropriate to keep working to address these issues. Some areas of new activity include the development of a new formula, the CKD-EPI formula; consideration of common reference intervals for serum creatinine; estimation of GFR for drug monitoring purposes and racial effects. To date there has also been little co-ordinated progress for the paediatric population with regard to creatinine measurement, reference intervals and GFR estimation. The joint working party of the Royal College of Pathologists of Australasia, the Australasian Association of Clinical Biochemists (AACB) and Kidney Health Australia plans to address these issues during 2010.

HbA1c — new unit of measurement necessitates a new educational exercise

For those of a certain generation there was a time before routine HbA1c measurement, when the adequacy of diabetes control was assessed simply from serial urine tests supplemented by the occasional random blood glucose estimation. Seemingly sufficient at the time, we now know this means of monitoring was clearly inadequate, and the consequence of such inevitable poor control was associated with a prevalence of serious long-term diabetic complications substantially higher than those seen today. Along with blood glucose self-monitoring, the introduction of HbA1c measurement in the early 1980s heralded an exceptional milestone in diabetes care, coincident with developing awareness that good diabetes control was important if risk of complications was to be minimised. The principle of having an extended time-linked indicator of diabetes control was an entirely new concept in clinical care and its implications were immediately apparent to both patient and doctor alike (no specialist nurses on the scene at this stage!). Initially restricted to specialist hospital-based diabetic clinics, where in fact the majority of people with diabetes were then seen, HbA1c testing gradually became an established part of good clinical practice in diabetes care and an essential component of the annual review process. Indeed, its importance is recognised by priority inclusion within current ‘Quality Framework’ targets. All now involved in delivering diabetes care will be fully familiar with the fundamental knowledge gained from HbA1c measurement as an indicator of overall glycaemic control and that, derived from studies such as DCCT and UKPDS, the results can be extrapolated to provide an evidenced-based signal of long-term risk for the development of diabetic complications. Health care professionals now depend on the ready availability of quality-assured, reliable HbA1c measurement and the latest result will always be a main focus of discussion in a clinical consultation. Much will pivot on that outcome. However, its interpretation has not always been that straightforward. The similarity of unit expression between blood glucose concentration and HbA1c as a percentage of total haemoglobin often gives rise to the impression that both are one and the same. Yet, they are clearly not so and with the HbA1c% tracking significantly below the average glucose, a false interpretation of control may be made. In addition, despite laboratory efforts to reference to the DCCT specific standard, a need for a better global standardisation has been identified. For these and other reasons from 1 June 2009 the unit of measurement of HbA1c will change to mmol/mol and the figures will look very different. For example, present HbA1c levels of 6.5% and 7.5% will be reported as 48 mmol/mol and 59 mmol/mol, respectively (Table 1). For two years the old units will still be provided in parallel. The principle of measurement remains the same and some limitations as previously in respect of certain confounding haematological disorders remain. Yet it will require a focused educational exercise to ensure that the new reporting of HbA1c is understood and implemented safely into routine clinical diabetes care. With this purpose in mind two information sheets, one for clinical health care professionals and one for people with diabetes, have been produced from the Association for Clinical Biochemistry, NHS Diabetes and Diabetes UK. Copies can be downloaded from the latter's website: www.diabetes.nhs.uk. The changeover is imminent but it will be an interesting transitional time.

Quality regulations and accreditation standards for clinical chemistry in Turkey

Objective The purpose of this paper is to review the current status of laboratory quality regulations and accreditation standards in Turkey. Design and method This paper is written based on the current regulations, information collected by available websites and congress proceedings, and personal communications. Results A total of 14 private and one public laboratory have been accredited according to ISO 15189 voluntarily. The total number of the JCI accredited hospitals is 24. One hospital has been accredited by HQS. A few medical laboratories have been accredited according to ISO 17025, whereas a lot of them have ISO 9001 certification from Turkish Accreditation Agency, TURKAK. There are no comprehensive laboratory standards and/or regulations to maintain a mandatory minimum quality of laboratories. External QC is not mandatory and there is no national proficiency testing program. It is a requirement to get a license to open a laboratory. There are residency programs for clinical chemistry and clinical microbiology. The Association of Clinical Biochemists, KBUD, is the youngest society in the field of clinical chemistry and is a leader in quality and accreditation activities. KBUDEK is an external QC program of KBUD. KBUD has organized four national and an international symposiums on quality and accreditation in addition to annual congresses and courses. Conclusion The new standard and regulation should be designed and applied to all laboratories to increase the quality of laboratory service in Turkey. It will be useful if the ISO 15189 standard can be incorporated into the national standards and regulations.