Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies.

OBJECTIVES: The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. METHODS: The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. RESULTS: Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. CONCLUSIONS: The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.

External quality assessment practices in medical laboratories: an IFCC global survey of member societies.

OBJECTIVES: Clinical laboratory results are required for critical medical decisions, underscoring the importance of quality results. As part of total quality management, external quality assessment (EQA) is a vital component to ensure laboratory accuracy. The goal of this survey was to evaluate the current status of global laboratory quality systems and assess the need for implementation, expansion, or harmonization of EQA programs (EQAP) for Clinical Chemistry and Laboratory Medicine. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC full and affiliate members (n=110) on laboratory quality practice. A total of 41 (37.3%) countries representing all IFCC regions except North America provided responses about EQA availability and practices. RESULTS: All 41 countries perform EQA, 38 reported that their laboratories had EQA policies and procedures, and 39 further act/evaluate unacceptable EQA results. 39 countries indicated they have international and/or national EQAP and 30 use alternative performance assessments. EQA frequency varied among countries. Generally, an EQAP provided the EQA materials (40/41) with four countries indicating that they did not have an EQAP in their country. CONCLUSIONS: Globally, most laboratories participate in an EQAP and have defined quality procedures for EQA. There remain gaps in EQA material availability and implementation of EQA as a part of a total laboratory quality system. This survey highlights the need for education, training, and harmonization and will guide efforts of the IFCC TF-GLQ in identifying areas for enhancing global laboratory quality practices.

Defining acceptable limits for the metrological traceability of specific measurands.

Although manufacturers are compelled by the European IVD Directive, 98/79/EC, to have traceability of the values assigned to their calibrators if suitable higher order reference materials and/or procedures are available, there is still no equivalence of results for many measurands determined in clinical laboratories. The adoption of assays with metrological traceable results will have a significant impact on laboratory medicine in that results will be equivalent across different laboratories and different analytical platforms. The IFCC WG on Allowable Errors for Traceable Results has been formed to define acceptable limits for metrological traceability chains for specific measurands in order to promote the equivalence of patient results. These limits are being developed based on biological variation for the specific measurands. Preliminary investigations have shown that for some measurands, it is possible for manufacturers to assign values to assay calibrators with a measurement uncertainty that allows the laboratory enough combined uncertainty for their routine measurements. However, for other measurands, e.g., plasma sodium, current assays are too imprecise to fulfil limits based on biological variation. Although an alternative approach based on probability theory is being investigated, the most desirable approach would be for industry to improve measurement methods so that they meet clinical requirements.

Effect of NT-proBNP testing on diagnostic certainty in patients admitted to the emergency department with possible heart failure.

BACKGROUND: Difficulty in distinguishing congestive heart failure (HF) from other causes of dyspnoea in the emergency department (ED) may result in delay in appropriate treatment and referral. Although the diagnostic value of serum amino-terminal pro-B-type natriuretic peptide (NT-proBNP) is well documented, the impact on diagnostic certainty of providing these results to ED physicians is not well studied. We sought to determine the effect of providing NT-proBNP results on diagnostic certainty of physicians managing patients presenting to the ED with suspected HF. METHODS: A randomized controlled study was conducted in 68 patients presenting to the ED with dyspnoea. ED clinicians initially rated the probability of HF as the cause of dyspnoea without the knowledge of the result. A scale of 1-7 was used, with 1 representing a high degree of certainty of a diagnosis other than HF and 7 representing a high degree of certainty of HF being the cause of dyspnoea. In 38 patients, the ED physician then reassessed the probability of HF as the cause of dyspnoea after receiving the NT-proBNP result. A cardiologist blinded to the NT-proBNP result determined the final diagnosis after review of medical records and investigations. RESULTS: Providing the NT-proBNP result reduced diagnostic uncertainty, defined as a test score of 3-5, from 66% of cases to 18% of cases (P < 0.0001) and improved diagnostic accuracy from 53% to 71% (P = 0.016). CONCLUSION: Measurement of NT-proBNP concentrations reduces diagnostic uncertainty and improves diagnostic accuracy in patients presenting to the ED with dyspnoea and possible HF.

Use of Capability Index to improve laboratory analytical performance.

* For detection of errors where the standard deviation is wide compared to clinical requirements, consider use of the Capability Index (Cps). * Cps is defined as 'Allowable Limit of Error divided by the standard deviation of between-batch QC measurement'. * 'Capable' assays have Cps >4 compared with 'incapable' ones with Cps <4. * Capability of an analyte can be used to optimise the amount of quality control (QC) required and still maintain appropriate error detection. * For EQA material, Cps can be used for continuously monitoring individual analytes, comparing laboratory performance with peers and comparison with industry-wide performance. * The capability approach can result in reducing the number of QCs run per day, reducing costs as well as significantly improving the performance of a number of assays.

The determination of the 99th centile level for troponin assays in an Australian reference population.

BACKGROUND: Current guidelines for the diagnosis and risk assessment of patients presenting with myocardial infarction recommend a single decision cut-off point for cardiac troponin (cTn) based on the 99th centile of a reference population. The 99th centile level for eight troponin assays was determined in an apparently cardio-healthy Australian reference population. METHODS: Nine laboratories measured troponin in serum and plasma collected from 111 reference individuals. An imprecision profile was determined using up to 10 serum samples analysed on 10 separate days. Method comparison using 100 routinely tested plasma samples was performed to estimate method concordance. RESULTS: Generally 99th centile values determined in this study were lower than, or the same as manufacturers' levels, except for cTnI by Architect (0.020 vs. 0.012 microg/L), and imprecision at the 99th centile was 20% coefficient of variation (CV) or higher. Troponin concentrations at 10% CV were greater than those quoted in the manufacturer's package insert except by AxSYM, 0.06 vs. 0.16 microg/L cTnI, and by E-170, 0.02 vs. 0.03 microg/L cTnT. In the method comparison 74, 70, 65, 75, 58, 66, 58 and 77 samples measured by Access, Architect, AxSYM, Centaur, Dimension RxL, E-170, i-STAT and Vitros ECi assays, respectively, had troponin concentrations above the study 99th centile. CONCLUSIONS: Depending on the selected reference population for troponin, there is likely to be variability in the 99th centile as shown in this study. Some differences in sample concordance at the 99th centile cut-off were observed between cTn methods and may result in different clinical classification.

EQA from an Australian perspective.

Enrolment in external quality assurance programs is part of the accreditation process for medical laboratories in Australia, with the majority of Australian laboratories being enrolled in programs from RCPA Quality Assurance Programs Pty Limited, a company owned by the Royal College of Pathologists of Australasia. An important feature of these programs is that they have been developed with the involvement and contribution of the profession. For example, the Chemical Pathology programs are a joint venture between the company and the Australasian Association of Clinical Biochemists (AACB). Some of the unique features of the programs are the composition of the material, the use of target values, the structure and information in the reports and the use of the internet for data entry and data review. Over the past thirty years, the development of these programs has made a significant contribution to the quality of laboratories in Australia.

Chronic kidney disease and automatic reporting of estimated glomerular filtration rate: a position statement.

The systematic staging of chronic kidney disease (CKD) by glomerular filtration measurement and proteinuria has allowed the development of rational and appropriate management plans. One of the barriers to early detection of CKD is the lack of a precise, reliable and consistent measure of kidney function. The most common measure of kidney function is currently serum creatinine concentration. It varies with age, sex, muscle mass and diet, and interlaboratory variation between measurements is as high as 20%. The reference interval for serum creatinine concentration includes up to 25% of people (particularly thin, elderly women) who have an estimated glomerular filtration rate (eGFR) that is significantly reduced (< 60 mL/min/1.73 m). The recent publication of a validated formula (MDRD) to estimate GFR from age, sex, race and serum creatinine concentration, without any requirement for measures of body mass, allows pathology laboratories to "automatically" generate eGFR from data already acquired. Automatic laboratory reporting of eGFR calculated from serum creatinine measurements would help to identify asymptomatic kidney dysfunction at an earlier stage. eGFR correlates well with complications of CKD and an increased risk of adverse outcomes such as cardiovascular morbidity and mortality. We recommend that pathology laboratories automatically report eGFR each time a serum creatinine test is ordered in adults. As the accuracy of eGFR is suboptimal in patients with normal or near-normal renal function, we recommend that calculated eGFRs above 60 mL/min/1.73 m be reported by laboratories as "> 60 mL/min/1.73 m", rather than as a precise figure.