Quality Assurance Scheme Research Articles

Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness

The implementation of infectious disease Point-of-Care (ID-POCT) diagnostics into the clinical environment lags behind the implementation of Point-of-Care diagnostics in other fields of medicine, especially in the field of clinical chemistry, where for example blood pressure and blood sugar POCT diagnostics are relatively common (1,2). In fact, the problems associated with the implementation of ID-POCT are numerous and currently include among others: a lack of reimbursement of costs by insurers, incomplete acceptance by physicians of the actual value of ID-POCT, and issues related to introducing ID-POCT into existing infectious disease clinical diagnostic work practices, e.g., coupling ID-POCT to existing laboratory information management systems, the establishment of new quality control and quality assurance schemes, training staff to perform non-routine manipulations, introducing new reporting procedures, etc.) (3-6). Additionally, although many existing and new ID-POCT devices are (becoming) available for clinicians to use, many of these have been/are being developed with a focus on adapting current state-of-the-art technologies to the medical environment, instead of focusing on the actual clinical need and then developing/adapting technologies to meet these actual needs (in terms of costs, ease-of-use, time-to-result, etc.). Performing research into the effect of ID-POCT, by for example measuring the impact of the use of ID-POCT in the clinical environment using parameters such as reduction in unnecessary antibiotic prescribing, shortening the length of hospital stay and rationalizing the use of isolation facilities, is one way of providing tangible evidence of the advantages, or disadvantages, of implementing ID-POCT into clinical environments. A recent study by Brendish et al. provides more evidence for the debate surrounding the implementation of ID-POCT into emergency departments and acute medical units (7,8).

Quality assurance of GEM foils for the upgrade of the ALICE TPC

With the planned upgrade of the ALICE Time Projection Chamber (TPC) the current readout technology will be replaced by a Gas Electron Multiplier (GEM)—based readout technology in order to allow for a continuous operation at high interaction rates up to 50 kHz. A stack of four GEM stages with non-standard field configuration was chosen to achieve a suppression of the ion backflow below 1%, while maintaining a good energy resolution below σ / E= \\unit[12]% for 55 Fe. A discharge probability of 10−10 for α-particles was confirmed for this low ion backflow field configuration. This is comparable to standard triple GEM detectors in low discharge settings. To upgrade all the Inner and Outer Readout Chambers of ALICE, 576 GEM foils will be needed. Only GEM foils that fullfill the highest quality criteria can be used. Therefore a quality assurance scheme has been developed that includes a large set of quality assurance measurements.

Diagnostic concordance of breast pathologists: lessons from the National Health Service Breast Screening Programme Pathology External Quality Assurance Scheme.

Previous concordance studies examining accuracy of breast diagnosis by pathologists, typically targeting difficult, histologically challenging breast lesions using artificial and restrictive environments, have reported aberrantly high levels of diagnostic discordance. The results of these studies may be misinterpreted by non-pathologists and raise concerns relating to routine practice. This study aims to assess the diagnostic agreement among UK breast pathologists. Two hundred and forty consecutive breast lesions, submitted by participants from their routine practice, included in the UK National Health Service Breast Screening Programme (NHSBSP) breast pathology EQA scheme during the last 10 years were reviewed. An average of approximately 600 participants viewed each case. Data on diagnostic categories (benign, atypical, in-situ malignant and invasive malignant) were collected. In this study, benign and atypical diagnoses were grouped together. The overall diagnostic agreement level was in the almost perfect range. Thirty-five cases (14.6%) showed diagnostic concordance of ≤95%. Reasons for discordance included one or more of: (1) scheme methodology limitations such as: (i) miscoding of certain lesions (e.g. phyllodes tumours and lobular neoplasia) (n = 7) and (ii) variable representation of the index lesion on glass slides (n = 18); and (2) diagnostically challenging cases that may be interpreted more easily using immunohistochemistry (n = 28). These latter included benign and malignant papillary lesions (n = 12), complex sclerosing lesions (n = 7), intraductal epithelial proliferative lesions (n = 6) and an unusual special tumour type (n = 1). Further review identified pathologists' misinterpretation in 13 cases (5.4%), with an average discordance rate of only 4.2%. The performance of breast pathologists is high. Exclusion of the effect of the scheme methodology limitations highlights further the high performance rate and identifies true diagnostically challenging entities. These difficult cases may benefit from additional diagnostic work-up and second opinions.

Adequately defining tumor cell proportion in tissue samples for molecular testing improves interobserver reproducibility of its assessment.

Gene mutation status assessment of tumors has become standard practice in diagnostic pathology. This is done using samples comprising tumor cells but also non-tumor cells, which may dramatically dilute the proportion of tumor DNA and induce false negative results. Increasing sensitivity of molecular tests presently allows detection of a targeted mutation in a sample with a small percentage of tumor cells, but assessment of tumor cellularity remains essential to adequately interpret the results of molecular tests. Comprehensive tumor cell counting would provide the most reliable approach but is time consuming, and therefore rough global estimations are used, the reliability of which has been questioned in view of their potential clinical impact. The French association for quality assurance in pathology (AFAQAP) conducted two external quality assurance schemes, partly in partnership with the French group of oncology cytogenomics (GFCO). The purpose of the schemes was to (1) evaluate how tumor cellularity is assessed on tissue samples, (2) identify reasons for discrepancies, and (3) provide recommendations for standardization and improvement. Tumor cell percentages in tissue samples of lung and colon cancer were estimated by 40-50 participants, on 10 H&E virtual slides and 20 H&E conventional slides. The average difference between lowest and highest estimated percentage was 66. This was largely due to inadequate definition of cellularity, reflecting confusion between the percentage of tumor cells and the percentage of the area occupied by tumor in the assessed region. The widest range of interobserver variation was observed for samples with dense or scattered lymphocytic infiltrates or with mucinous stroma. Estimations were more accurate in cases with a low percentage of tumor cells. Macrodissection of the most homogeneous area in the tissue reduced inter-laboratory variation. We developed a rating system indicating potential clinical impact of a discrepancy. Fewer discrepancies were clinically relevant since the study was conducted. Although semi-quantitative estimations remain somewhat subjective, their reliability improves when tumor cellularity is adequately defined and heterogeneous tissue samples are macrodissected for molecular analysis.

Higher technical skills

Purpose The purpose of this paper is to report the findings of a joint study carried out with groups of colleges in England and technical and further education (TAFE) institutes in Australia. It looks at the factors which promote the delivery of higher technical skills and the infrastructure arrangements that are needed for success. It relates these to the debate concerning the promotion of higher and degree apprenticeships (HAs and DAs) in England. Design/methodology/approach The report is derived from a series of interviews with college and TAFE staff. A policy comparison is also included to provide context. Findings The outcome of the study suggests that similar factors affect the decision to offer, pursue and contribute to the development of higher technical skills in both countries. HAs and DAs are an English construct and the experience of colleges involved in HAs adds a valuable contribution to discussions surrounding the marketing and delivery of DAs. The Australian decision not to pursue either structure encourages reflection on what it is that governments are trying to achieve and what lessons can be learned from their approach. Research limitations/implications The study was carried out within the non-university sector in both countries. Colleges and TAFE institutes are more likely to offer practice-based higher education (HE), have teaching staff with industry backgrounds and have long-established engagement with employers that may be found within universities. The paper was therefore written from a distinctive environment. However, it is likely that the issues identified apply to universities and private providers of HE as much as to colleges and TAFEs. Practical implications The findings suggest that developing HAs or DAs should not be seen merely as just another marketing opportunity. The hybrid nature of both structures requires a holistic approach to delivery on the part of institutional leaders that leads to significant overhaul of internal communications networks, quality assurance schemes and staff development. Originality/value The paper is one of relatively few published documents which focus on the role of dual sector colleges and TAFE institutes in the delivery of HE and higher technical skills. It offers insight into how government pressure for a particular style of HE, deemed necessary for the national economic interest of both countries, can be made into a reality. By using the expertise that already exists within the college and TAFE sectors and their established links with employers, more effective changes can be made at a faster pace.

Variability in physical contamination assessment of source segregated biodegradable municipal waste derived composts

Physical contaminants (glass, metal, plastic and ‘other’) and stones were isolated and categorised from three finished commercial composts derived from source segregated biodegradable municipal waste (BMW). A subset of the identified physical contaminant fragments were subsequently reintroduced into the cleaned compost samples and sent to three commercial laboratories for testing in an inter-laboratory trial using the current PAS100:2011 method (AfOR MT PC&S). The trial showed that the ‘other’ category caused difficulty for all three laboratories with under reporting, particularly of the most common ‘other’ contaminants (paper and cardboard) and, over-reporting of non-man-made fragments. One laboratory underreported metal contaminant fragments (spiked as silver foil) in three samples. Glass, plastic and stones were variably underreported due to miss-classification or over reported due to contamination with compost (organic) fragments. The results are discussed in the context of global physical contaminant test methods and compost quality assurance schemes.

Effect of Participating in a Quality Improvement System over Time for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing.

Users of point-of-care testing (POCT) in Norway participate in a quality improvement system that includes education and guidance in safe laboratory management along with participation in external quality assurance schemes (EQAS).The aim of this study was to identify the effect on the analytical performance of POCT C-reactive protein (CRP), glucose, and hemoglobin (Hb) with the use of a quality improvement system over time and to identify which factors are associated with good performance. Participants' results from 19 EQAS for CRP, glucose, and Hb from 2006 to 2015 along with information on the instruments used and different practice characteristics were analyzed. Logistic regression analysis was used to evaluate the factors associated with good laboratory performance. An instrument evaluation and comparison for CRP determination was performed by using commutable EQA material. The mean number of participants in each EQAS was 2134, 2357, and 2271 for CRP, glucose, and Hb, respectively. The percentage of good participant performances increased gradually whereas that of poor performances decreased with participation in a quality improvement system over 9 years for all 3 analytes. Independent factors associated with good performance were type of instrument, the number of times performing EQA, performing internal QC weekly, performing 10 or more tests weekly, and having laboratory-qualified personnel perform the tests. Considering CRP instrument performance, Afinion and QuikRead exhibited the lowest systematic deviation. The analytical quality of CRP, glucose, and Hb testing is improved by systematic participation in a quality improvement system over time.

A system to measure the data quality of spectral remote sensing reflectance of aquatic environments

Spectral remote sensing reflectance (Rrs, sr−1) is the key for ocean color retrieval of water bio-optical properties. Since Rrs from in-situ and satellite systems are subject to errors or artifacts, assessment of the quality of Rrs data is critical. From a large collection of high quality in situ hyperspectral Rrs datasets, we developed a novel quality assurance (QA) system that can be used to objectively evaluate the quality of an individual Rrs spectrum. This QA scheme consists of a unique Rrs spectral reference and a score metric. The reference system includes Rrs spectra of 23 optical water types ranging from purple blue to yellow waters, with an upper and a lower bound defined for each water type. The scoring system is to compare any target Rrs spectrum with the reference and a score between 0 and 1 will be assigned to the target spectrum, with 1 for perfect Rrs spectrum and 0 for unusable Rrs spectrum. The effectiveness of this QA system is evaluated with both synthetic and in situ Rrs spectra and it is found to be robust. Further testing is performed with the NOMAD dataset as well as with satellite Rrs over coastal and oceanic waters, where questionable or likely erroneous Rrs spectra are shown to be well identifiable with this QA system. Our results suggest that applications of this QA system to in situ datasets can improve the development and validation of bio-optical algorithms and its application to ocean color satellite data can improve the short- and long-term products by objectively excluding questionable Rrs data. This article is protected by copyright. All rights reserved.

91. Efficacy of multidisciplinary meetings on breast cancer outcomes. A systematic review and pooled analysis. European Commission Initiative on Breast Cancer, Quality Assurance Scheme Development Group, and Iberoamerican Cochrane Centre contributed

91. Efficacy of multidisciplinary meetings on breast cancer outcomes. A systematic review and pooled analysis. European Commission Initiative on Breast Cancer, Quality Assurance Scheme Development Group, and Iberoamerican Cochrane Centre contributed

Falsely low immunoglobulin (Ig)G4 in routine analysis: how not to miss IgG4 disease.

Immunoglobulin (Ig)G4 disease can have apparently 'normal' levels of IgG4 due to antigen excess conditions. IgG4 measurement therefore appears falsely low. UK National External Quality Assurance Scheme (UK NEQAS) data and other reports have suggested that this problem occurred despite pre-existing antigen excess detection steps. To determine the clinical relevance of the problem, we examined the prevalence and characteristics of prozoning in our laboratory and patient cohorts. We establish that the prevalence of raised IgG4 in routine IgG4 analysis is low (< 1%) using one of the two routine methods in use in the United Kingdom. We show that subsequent assay modification appears to have reduced the likelihood of misleading readings. However, the original version of the assay prozoned to low levels (below 0·64 g/l) in 41% of high IgG4 samples in our patients. This may explain the previous reports of low sensitivity of raised IgG4 for IgG4RD, and predictive values should be re-evaluated in this disease using modified prozone-resistant protocols. All laboratories providing IgG4 measurements should verify that their assays are fit for the clinical quality requirement of detection raised IgG4 levels and must verify the upper limit of their reference ranges and freedom from prozoning.

Post-standardization of routine creatinine assays: are they suitable for clinical applications.

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239 μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100 μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based.

A way of policy bricolage or translation: The case of Taiwan’s higher education reform of quality assurance

This paper focuses on the process and mechanism of higher education policy change related to quality assurance in a globalized world. In particular, the purpose of the study was to identify the impact of globalization on domestic policy change in Taiwan, characterized as a peripheral country. Taiwan’s experience in terms of developing a national quality assurance system for higher education (1975–2013) was analyzed as a case study, based on the theories of new institutionalism. The analysis showed that in the whole process of policy change, the government retained significance through playing the role of policy entrepreneur. Regarding the mechanism of policy change, both bricolage and translation were identified in the process. However, translation tended to appear in the most recent period, which saw quality assurance schemes that spread from other places adopted in the local context, albeit with considerable modification. This would imply that, even in the global context, higher education policy change could come in different forms.

Laboratory Innovation Towards Quality Program Sustainability.

Laboratory innovation significantly affects program sustainability of HIV programs in low and middle income countries (LMICs) far beyond its immediate sphere of impact. Innovation in rapid development of diagnostic technologies, improved quality management systems, strengthened laboratory management, affordable external quality assurance and accreditation schemes, and building local capacity have reduced costs, brought quality improvement to point-of-care testing, increased access to testing services, reduced treatment and prevention costs and opened the door to the real possibility of ending the AIDS epidemic. However, for effectively implemented laboratory innovation to contribute to HIV quality program sustainability, it must be implemented within the overall context of the national strategic plan and HIV treatment programs. The high quality of HIV rapid diagnostic test was a breakthrough that made it possible for more persons to learn their HIV status, receive counseling, and if infected to receive treatment. Likewise, the use of dried blood spots made the shipment of samples easier for the assessment of different variables of HIV infection-molecular diagnosis, CD4+ cell counts, HIV antibodies, drug resistance surveillance, and even antiretroviral drug level measurements. Such advancement is critical for to reaching the UNAIDS target of 90-90-90 and for bringing the AIDS epidemic to an end, especially in LMICs.

Papillary carcinoma of the breast: diagnostic agreement and management implications

Papillary carcinoma (PC), which is a rare type of breast cancer, comprises a heterogeneous group of tumours. The diagnostic categorization of PC as in-situ and invasive disease remains a matter of debate with respect to interpretation of its overlapping histological features, and with respect to the uncertainty in clinical behaviour that this dilemma raises. The aim of this study was to assess the diagnostic agreement regarding PC among reporting breast pathologists. Six cases of PC included in the UK National Health Service Breast Screening Programme breast pathology interpretive external quality assurance scheme in the last 10 years were reviewed. In this scheme, one representative haematoxylin and eosin-stained slide from each case is circulated to an average of 600 participants. Data on diagnostic categories were collected and slides were reviewed according to the World Health Organization (WHO) diagnostic criteria. The number of final diagnoses of malignancy (in situ or invasive) was highest for invasive PC (99% of the participants diagnosed it as malignant), followed by solid PC (94% and 95%, respectively), encapsulated PC (92% and 92%, respectively), and papillary ductal carcinoma in situ (DCIS) (88%). Most cases of papillary DCIS were correctly classified as in-situ disease (77%), but 28% of the participants classified invasive PC cases as in-situ disease. Of the participants, 24% reported encapsulated PC as invasive disease. Of the two solid PC cases, one showed some features consistent with the WHO description of invasive solid PC, whereas the other showed features of classic (non-invasive) solid PC. Both cases were reported as invasive by 75% and 77% of participants, respectively. Breast specialists more frequently classified PC as an in-situ carcinoma than did non-specialist participants, and the difference was significant (P = 0.013). Recognition of PC as a malignant entity (in situ or invasive) is high, but concordance of its classification into in-situ and invasive disease is low. Histological features that can define invasion in PC should be better defined. These rare lesions require additional diagnostic work-up, and difficult cases should trigger consensus opinion or expert referral.

Bias, its minimization or circumvention to simplify internal quality assurance

Abstract Several concepts of analytical bias and remedies to minimize bias have been suggested with the ultimate goal to disregard it. Short-term bias (within one control cycle) should be treated as a random error if it is less than the permissible limits. Long-term bias should be eliminated if it is known or circumvented by estimating intra-laboratory reference limits (RLs). Consequently, analytical uncertainty could be reduced to permissible imprecision. Then, models combining imprecision and bias would become irrelevant, and the numerical value of total analytical error would become identical with imprecision. The purpose of the present report is to simplify quality assurance schemes considerably by disregarding bias either by estimating RLs or by verifying the applied reference limits (checking the transferability) as requested by ISO and CLSI.

Review of the national external quality assessment (EQA) scheme for breast pathology in the UK

BackgroundThe National Health Service Breast Screening Programme (NHSBSP; pathology) external quality assurance (EQA) scheme aims to provide a mechanism for examination and monitoring of concordance of pathology reporting within the...

THE PROTEAN PRINCIPLE OF PROPORTIONALITY: HOW DIFFERENT IS PROPORTIONALITY IN EU CONTEXTS?

THE Legal Services Board, tasked with the supervision of approved regulators of persons carrying on legal activities, granted an application (by the Bar Standards Board, Solicitors Regulation Authority, and ILEX Professional Standards Board) for approval of alterations to their regulatory arrangements to give effect to the so-called Quality Assurance Scheme for Advocates (“the decision”). The Scheme provides for judicial assessment of criminal advocates in England and Wales: only those deemed “competent” would gain full accreditation for upper levels of criminal work. Judicial review had been sought, unsuccessfully in the courts below, by barristers practising criminal law. The question in R. (on the application of Lumsdon and others) v Legal Services Board [2015] UKSC 41; [2015] 3 W.L.R. 121 was whether the decision was contrary to Regulation 14 of the Provision of Service Regulations 2009 (SI 2999/2009), which implemented Directive 2006/123/EC (O.J. No. L 376, p. 36). Regulation 14 requires that any authorisation scheme cannot be set unless, inter alia, the need for such a scheme is “justified by an overriding reason relating to the public interest” and the scheme's objective “cannot be attained by means of a less restrictive measure” (see Regulation 14(2)).

Two-dimensional liquid chromatography coupled to tandem mass spectrometry for vitamin D metabolite profiling including the C3-epimer-25-monohydroxyvitamin D3

A method based on automated on-line solid phase extraction coupled to two-dimensional liquid chromatography with tandem mass spectrometry detection (SPE-2DLC–MS/MS) is here reported for vitamin D metabolite profiling in human serum with absolute quantitation. Two-dimensional LC was configured with two complementary analytical columns, pentafluorophenyl (PFP) and C18 phases, for determination of 25 hydroxyvitamin D3 epimers and the resting bioactive metabolites of vitamin D (D3 and D2)-25-hydroxyvitamin D2, 1,25-dihydroxyvitamin D3, 1,25-dihydroxyvitamin D2 and 24,25-dihydroxyvitamin D3. Quantitative determination was supported on the use of a stable isotopic labelled internal standard for each analyte and the resulting method was validated by analysis of a standard reference material certified by the National Institute of Standards & Technology (NIST-972a) and 5 samples provided by the vitamin D External Quality Assurance Scheme (DEQAS). The limits of detection were between 9 and 90pg/mL for the eight analytes, and precision, expressed as relative standard deviation, was lower than 11.6%. Two-dimensional LC has shown to be the key to discriminate between 25 hydroxyvitamin D3 epimers in a quantitative analysis also involving dihydroxyvitamin D metabolites.

External quality assessment of AFB smear microscopy performances and its associated factors in selected private health facilities in Addis Ababa, Ethiopia.

Tuberculosis (TB) is still a public health problem in sub Saharan African countries. In resource-limited settings, TB diagnosis relies on sputum smear microscopy, with low and variable sensitivities, especially in paucibacillary pediatric and HIV-associated TB patients. Tuberculosis microscopy centers have several weaknesses like overworking, insufficiently trained personnel, inconsistent reagent supplies, and poorly maintained equipments; thus, there is a critical need for investments in laboratory infrastructure, capacity building, and quality assurance schemes. The performance of TB microscopy centers in the private health facilities in Addis Ababa is not known so far. The main objective of the study was to assess laboratory performance of acid fast bacilli (AFB) smear microscopy and its associated factors in selected private health facilities in Addis Ababa, Ethiopia. A cross-sectional study was conducted in 33 selected private health facilities of Addis Ababa, Ethiopia comprising 7 hospitals, 2 NGO health centers, 23 higher clinics and 1 diagnostic laboratory that provide AFB smear microscopy services. The study was conducted from January to April 2014. A total of 283 stained sputum smears were randomly collected from participant laboratories for blinded rechecking, 320 panel slides were sent to 32 microscopy centers to evaluate their performance on AFB reading, staining and reporting. Checklists were used to assess quality issues of laboratories. Data were captured, cleaned, and analyzed using SPSS version 16.0; χ2 tests, kappa statistics were used for comparison purpose. P value < 0.05 considered statistically significant. Among the 32 participant laboratories, 2-scored 100%, 15 scored 80-95% & the remaining 15 scored 50-75% for overall proficiency test performance. There were 10 (3.15%) major errors and 121 (37.8%) minor errors. The sensitivity, specificity, PPV and NPV of panel reading by microscopy centers were 89%, 96%, 96%, and 90% respectively. Out of 283 randomly selected slides for blind rechecking, 11 (3.9%) slides interpreted falsely for AFB, with overall agreement of 97.5%, sensitivity of 88.4% and specificity of 99.3%. In terms of slide quality assessment, 71.6% of AFB slides were graded as good for evenness, cleanness, thickness, size, staining and labeling. The performance score for AFB slide evenness was 56.9% (161 slides) and for labeling quality was 90.8% (257 slides); having significant difference in slide quality (p value < 0.05). On-site evaluation indicated problems in terms of infrastructure, standard operating procedure, reagent quality; equipment maintenance, data management and training issues. Most of the health facilities had poor maintenance scheme for microscope (53.5%) and poor inventory management (25.0%) system. Microscopy centers that scored a proficiency of 75.5%; which is below the acceptable minimum score of 80% and an overall error rate of 3.9% for blinded rechecking needs attention. Moreover, there are gaps identified through on site assessment including poor SOP, reagent quality, equipment maintenance, data management & lack of updated training on AFB microscopy techniques, requiring a concerted effort to alleviate the bottle neck problems and strengthening the public private partnership to control TB.

Pilot Experience with an External Quality Assurance Scheme for Acylcarnitines in Plasma/Serum.

The analysis of acylcarnitines (AC) in plasma/serum is established as a useful test for the biochemical diagnosis and the monitoring of treatment of organic acidurias and fatty acid oxidation defects. External quality assurance (EQA) for qualitative and quantitative AC is offered by ERNDIM and CDC in dried blood spots but not in plasma/serum samples. A pilot interlaboratory comparison between 14 European laboratories was performed over 3 years using serum/plasma samples from patients with an established diagnosis of an organic aciduria or fatty acid oxidation defect. Twenty-three different samples with a short clinical description were circulated. Participants were asked to specify the method used to analyze diagnostic AC, to give quantitative data for diagnostic AC with the corresponding reference values, possible diagnosis, and advice for further investigations.Although the reference and pathological concentrations of AC varied among laboratories, elevated marker AC for propionic acidemia, isovaleric acidemia, medium-chain acyl-CoA dehydrogenase, very long-chain acyl-CoA dehydrogenase, and multiple acyl-CoA dehydrogenase deficiencies were correctly identified by all participants allowing the diagnosis of these diseases. Conversely, the increased concentrations of dicarboxylic AC were not always identified, and therefore the correct diagnosis was not reach by some participants, as exemplified in cases of malonic aciduria and 3-hydroxy-3-methylglutaryl-CoA lyase deficiency. Misinterpretation occurred in those laboratories that used multiple-reaction monitoring acquisition mode, did not derivatize, or did not separate isomers. However, some of these laboratories suggested further analyses to clarify the diagnosis.This pilot experience highlights the importance of an EQA scheme for AC in plasma.