Quality Assurance Scheme Research Articles

Measurement of teicoplanin by liquid chromatography-tandem mass spectrometry: development of a novel method

Teicoplanin is an antibiotic used for the treatment of endocarditis, osteomyelitis, septic arthritis and methicillin-resistant Staphylococcus aureus. Teicoplanin is emerging as a suitable alternative antibiotic to vancomycin, where their trough serum levels are monitored by immunoassay routinely. This is the first report detailing the development of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for measuring teicoplanin in patients' serum. An Acquity™ UPLC (ultra-pressure liquid chromatography) tandem mass spectrometer was used to measure teicoplanin concentrations in samples from patients, quality assurance schemes and quality control preparations. Ristocetin was successfully implemented as a suitable internal standard. Ion suppression, linearity, stability, matrix effects, recovery, imprecision, lower limits of quantification and detection, interference and method comparison against immunoassay were all assessed. Teicoplanin and ristocetin had elution times of 1.39 and 1.24 min, respectively. Ion suppression was shown to be negligible, and linear calibration curves (0-200 μg/mL) were consistently reproduced to have r(2) values >0.99. Postextraction stability was achieved up to 20 h, while matrix effects were minimal coupled with sample recovery of >93%. The lower limit of quantification was 1 μg/mL, and 0.2 μg/mL was the lower limit of detection. Interference with other antibiotics was dependent on the combination of drugs present in patients' serum. A method comparison between immunoassay and LC-MS/MS suggested a negative bias for tandem mass spectrometry. This novel method of teicoplanin determination by LC-MS/MS is proven to be a robust protocol that is consistent and reproducible. Clinicians searching for alternatives in therapeutic drug monitoring may have an additional option that is potentially more accurate and specific.

AN OVERVIEW OF CURRENT UK FRESH PRODUCE FARMING PRACTICES THAT MINIMISE THE RISK OF FOODBORNE ILLNESS OUTBREAKS ASSOCIATED WITH READY TO EAT FRESH PRODUCE

As a consequence of recent outbreaks of food borne illness associated with consumption of fresh produce, there is increased scrutiny of the microbiological risks associated with the consumption of ready to eat produce within the UK retail sector This project was funded to summarise the UK industry approach to managing risk in fresh produce production and identify best practices and areas of risk. Copies of quality assurance scheme codes of practice for fresh produce growers were reviewed from a food safety viewpoint against the stipulations of Codex Alimentarius. In general, all of the guides require good practices conducive with the production of food that is free from human pathogens. A survey of growers was undertaken to assess compliance with these codes and to identify areas in the codes that growers found difficult to comply with or to implement. Growers find it difficult to risk assess water sources used for irrigation and water usage. Furthermore, the selection of bacterial indicators that were encountered was diverse and growers experienced difficulty in choosing appropriate indicators to test for, and in using the results of these tests as the basis of informed decisions. Large growers supplying the UK multiple retail chains are required by their customers to comply with one or more assurance code as a condition for the sale of their produce. Small growers that supply farmers’ markets and wholesalers are under little or no pressure from their customers to do the same. This disparity in supply chains suggest that moves to encourage wholesalers to comply with assurance schemes would help reduce the risks to UK consumers from the consumption of fresh produce.

QuILT: Covering every aspect of quality

Nursery WorldVol. 2012, No. 7 FeatureQuILT: Covering every aspect of qualityPublished Online:4 Mar 2014https://doi.org/10.12968/nuwa.2012.9.7.1106163AboutSectionsView articleView Full TextView EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View articleAbstractJudith Twani, independent early years consultant, trainer and early education improvement officer for Thurrock Council, explains how a modular quality assurance and improvement scheme is proving both versatile and enduring for a range of settings FiguresReferencesRelatedDetails 1 July 2012Volume 2012Issue 7ISSN (print): 0029-6422ISSN (online): 2059-9358 Metrics History Published online 4 March 2014 Published in print 1 July 2012 Information© MA Education Ltd

Measuring farmers' attitudes to animal welfare and health

PurposeThe purpose of this study was to develop a behavioural framework for developing a scale to measure farmers' attitudes to animal welfare and health and to take an explorative approach to initiating development of such a scale.Design/methodology/approachA literature review was used to develop the behavioural framework. Exploratory factor analysis was then used to initiate development of a measurement scale, based on a sample of 108 Swedish livestock farmers.FindingsBased on the framework developed, the authors' data suggest unidimensionality of farmers' attitudes to animal welfare and health; and that farmers perceive animal welfare as being about animal health and comfort in particular.Research limitations/implicationsFurther research should be devoted to this area to develop a more final measurement scale. This could be done by re‐evaluating the scale obtained in this paper in both exploratory and confirmatory factor analysis settings. The behavioural framework proposed here provides a basis for such scale development and a more rigid framework for evaluating and comparing farmers' attitudes to animal welfare.Practical implicationsThe behavioural framework and scale development initiated in this paper can be used by policymakers and organizations responsible for quality assurance schemes to develop policy measures and education programmes to re‐train farmers' behaviour into a system that supports higher animal welfare and health standards.Originality/valueThe originality of this paper is that it develops and uses a behavioural framework based on psychological and psychometric theory to initiate development of a scale to measure farmers' attitudes to animal welfare and health.

Cross-Examination of Vulnerable Witnesses—Towards a Blueprint for Re-Professionalisation

There is now an abundance of research, across a range of jurisdictions, to establish that cross-examination techniques traditionally deployed in adversarial systems can confuse vulnerable witnesses, reduce their ability to comprehend the issues and diminish the cogency and accuracy of their testimony. The nature of the problem and its scale will be illustrated in this article primarily by reference to children and people with mental disabilities or learning difficulties. The core of the problem is the limited understanding on the part of some advocates of the special needs of vulnerable witnesses and their reluctance or inability to abandon or modify traditional cross-examination techniques. The scale of the problem is considerable, having regard to the growth in the number of vulnerable witnesses and evidence of their negative perceptions of the experience of testifying. Except in jurisdictions in which the cross-examination has effectively been removed entirely from the hands of the advocate, legal developments have focused on the use of pre-trial recordings, intermediaries, improved judicial training and enhanced powers to curtail improper cross-examination. These reflect an ‘accommodation approach’ that has had a limited educative effect on practitioners. The professional duty of the advocate is not to ignore or take advantage of the difficulties faced by vulnerable witnesses, but to develop new methods to test their evidence. There is an urgent need for re-professionalisation, i.e. the development and introduction of new systems for the training and accreditation of advocates, involving a fundamental culture change and the acquisition of new specialist knowledge and skills. This article explores what such re-professionalisation should involve. It analyses critically two recent sets of proposals : proposals for the implementation of a quality assurance scheme put forward by the English legal regulatory authorities, and proposals for training and accreditation schemes put forward by the Advocacy Training Council, the joint body of the four Inns of Court with responsibility for overseeing standards of advocacy training for the Bar of England and Wales. Regard is also had to relevant pedagogical precepts and recent relevant case law.

Governing Cooperative Quality Schemes

This paper describes the development, functioning and governance of quality assurance schemes for olive oil in three cooperative organizations. Two questions are addressed: first, how the construction of new quality schemes by cooperatives can lead to the fragmentation of the membership base, and hence the need for new institutional arrangements; and second, how the development of such schemes alters the interdependencies between parties (cooperative organization and its members), and how this is governed. The comparative analysis shows the relevance of the social and cultural contexts in shaping the mechanisms of governance, as well contributing to the policy debate in the European Union regarding new food quality schemes.

Internal Quality Assurance Program for ERBB2 (HER2) Testing Improves the Selection of Breast Cancer Patients for Treatment with Trastuzumab

International guidelines for ERBB2 (HER2) testing procedures in breast cancer patients highlight the importance of external quality control. In contrast, internal quality assurance programs have been poorly defined, and their clinical significance has not yet been investigated. We developed a quality assurance scheme by performing HER2 FISH on 724 patients randomly selected out of 1996 patients with breast cancer presenting at our institute. We collected samples monthly for tissue microarray analysis and correlated HER2 gene status with IHC scores. The concordance was excellent (κ = 0.92, P < 0.0001). HER2 amplification characterized 25% of score 2+ but also 13% of score 1+, thus expanding the number of patients eligible for trastuzumab. Based on these findings, the FISH test is now recommended at our institution for score 1+ and 2+ patients. Adherence to internal assurance program improves patient selection and may lead to the definition of in-house tailored diagnostic algorithms different from those proposed in international guidelines.

Preparation, certification and interlaboratory analysis of workplace air filters spiked with high-fired beryllium oxide

Occupational sampling and analysis for multiple elements is generally approached using various approved methods from authoritative government sources such as the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA), as well as consensus standards bodies such as ASTM International. The constituents of a sample can exist as unidentified compounds requiring sample preparation to be chosen appropriately, as in the case of beryllium in the form of beryllium oxide (BeO). An interlaboratory study was performed to collect analytical data from volunteer laboratories to examine the effectiveness of methods currently in use for preparation and analysis of samples containing calcined BeO powder. NIST SRM(®) 1877 high-fired BeO powder (1100 to 1200 °C calcining temperature; count median primary particle diameter 0.12 μm) was used to spike air filter media as a representative form of beryllium particulate matter present in workplace sampling that is known to be resistant to dissolution. The BeO powder standard reference material was gravimetrically prepared in a suspension and deposited onto 37 mm mixed cellulose ester air filters at five different levels between 0.5 μg and 25 μg of Be (as BeO). Sample sets consisting of five BeO-spiked filters (in duplicate) and two blank filters, for a total of twelve unique air filter samples per set, were submitted as blind samples to each of 27 participating laboratories. Participants were instructed to follow their current process for sample preparation and utilize their normal analytical methods for processing samples containing substances of this nature. Laboratories using more than one sample preparation and analysis method were provided with more than one sample set. Results from 34 data sets ultimately received from the 27 volunteer laboratories were subjected to applicable statistical analyses. The observed performance data show that sample preparations using nitric acid alone, or combinations of nitric and hydrochloric acids, are not effective for complete extraction of Be from the SRM 1877 refractory BeO particulate matter spiked on air filters; but that effective recovery can be achieved by using sample preparation procedures utilizing either sulfuric or hydrofluoric acid, or by using methodologies involving ammonium bifluoride with heating. Laboratories responsible for quantitative determination of Be in workplace samples that may contain high-fired BeO should use quality assurance schemes that include BeO-spiked sampling media, rather than solely media spiked with soluble Be compounds, and should ensure that methods capable of quantitative digestion of Be from the actual material present are used.

Scientific Opinion on the use of animal-based measures to assess welfare in pigs

Animal-based measures, identified on the basis of scientific evidence, can be used effectively in the evaluation of the welfare of on-farm pigs in relation to laws, codes of practice, quality assurance schemes and management. Some of these measures are also appropriate for ante-mortem inspection and there are additional post-mortem animal-based measures which can be taken at the slaughterhouse. Non-animal-based measures can be used when the association between them and the welfare outcome is strong and when they are more efficient than animalbased measures as a means to safeguard welfare. Both animal-based and non-animal-based measures can be useful predictors of welfare in pigs. In order to assess welfare, a wide range of measures is needed. However, to assess aspects of welfare it is unnecessary to use all animal-based measures on every occasion. The choice of animal-based measures will depend upon the specific objectives of the assessment. The full list is comparable to a ‘toolbox’, from which the appropriate range of measures can be selected. The Welfare Quality® protocol provides information on the majority of the welfare outcomes of the main hazards identified in the EFSA Scientific Opinions but not those where time limitation prevents it. There are currently insufficient animal-based measures to use as welfare outcome indicators on-farm or in the slaughterhouse to assess the issues of pain, frustration and other positive and negative emotional states. The extent to which short-term management can prevent the negative effects of hazards arising from genetic selection, and of most housing-related problems, is extremely limited. Herd monitoring and surveillance programmes should be implemented within the pig industry using a range of appropriate animal-based measures to document welfare changes over time. There should be both initial and ongoing training of assessors to ensure valid and reliable welfare measurement.

Quality assurance, part 1 - E-Quality Counts: Helping staff to work together

Nursery WorldVol. 2012, No. 1 FeatureQuality assurance, part 1 - E-Quality Counts: Helping staff to work togetherMary EvansMary EvansSearch for more papers by this authorMary EvansPublished Online:4 Mar 2014https://doi.org/10.12968/nuwa.2012.9.1.1096759AboutSectionsView articleView Full TextView EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View articleAbstractThe NDNA's online quality assurance scheme aims to maximise the potential of every individual to energise practice and keep it moving forward, as Mary Evans hears at the start of a new series. FiguresReferencesRelatedDetails 1 January 2012Volume 2012Issue 1ISSN (print): 0029-6422ISSN (online): 2059-9358 Metrics History Published online 4 March 2014 Published in print 1 January 2012 Information© MA Education Ltd

External Quality Assurance Scheme in a National Reference Laboratory for HIV Testing in South India

Background: The Department of Experimental Medicine functions as the National Reference Laboratory (NRL) for HIV testing covering 11 Medical Colleges (State Reference Laboratories SRL) & 723 subcenters i.e. Integrated Counseling & Testing Centres and Blood Banks. The External Quality Assurance Scheme (EQAS) in NRL implements Quality Control (QC) Testing, Proficiency panel testing and training programs. Materials & Method: 9419 samples (4393 HIV negative/5026 HIV positive) were tested for QC. All the samples were tested using HIV rapid test (CombAids) and HIV positives alone were tested using Tridot and EIA Comb. The QC samples consisted of 20% negative and all positives. All the 723 subcenters were provided with 5 coded plasma samples (3 reactive & 2 negative) for proficiency testing using rapid tests. The aliquot panel (500 μl) were provided twice a year for testing to monitor the laboratory performance. Results: Out of 9419 samples tested for QC, 9371 (99.49%) reported correct results and 48 (0.50%) discordant results. Out of 48 samples 26 (0.27%) were false positives and 22 (0.23%) false negative. Mislabeling, sample contamination, leaking vials, transcriptional errors, tests that were not performed correctly were identified. For proficiency testing 91.8% reported test results. 645 (97.13%) reported correct results & 19 (2.86%) incorrect results. Out of 19 samples 7 (1.05%) were false positive & 12 (1.80%) were false negative. Hands on training were provided and the 19 discordant centers reported correct results on retesting. Conclusion: Significant progress in establishing a well coordinated HIV Laboratory network of NRL and SRLs had been developed. However the HIV testing and Quality Assurance needs to be strengthened towards certification.

PHP132 Use of a Disease Specific Quality of Life Tool in a Quality Assurance Scheme for Day Case Hernia Surgery

Outpatient services in Germany are less controlled by external quality assurance programs. Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g. for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has been recently proposed (Carolinas Comfort Scale, CCS). This study evaluates the integration of CCS as part of a multicentre quality assurance scheme for outpatient surgery. Sixteen ambulant centres developed a web-based quality assurance scheme for hernia day surgery in Germany. In an evaluation phase, all patients which were intended to treat with 3-dimensional meshes, were registered with consensus into a database through a web-based portal. CCS questionnaires were mailed to patients 4 and 12 weeks after surgery. Patients were requested to send pseudonymized responses to an independent party for inputting answers into the database. Clinical examinations were made 4 and 12 weeks postoperatively. Additional follow-up is planned 52 weeks after surgery. CSS consists of 23 questions in 7 activity- categories and 3 dimensions: sensation of mesh, movement limitations, pain. During the first year (Oct 2009 to Sept 2010) 1429 patients were registered (1271 male, 158 female, median age 53 years) and treated for primary (88%) or recurrent (11%) hernia. 1300 (90%)/1246 (87%) patients were clinically reviewed 4/12 weeks after surgery. 1072 (75%) /1002 (70%) questionnaires were retrieved 4/12 weeks after surgery. Patient satisfaction rate was 98%. CCS scores are shown to be decreased from 4 to 12 weeks in all dimensions (Sensation: 0.51 to 0.35, Movement: 0.40 to 0.20, pain: 0.45 to 0.26). CCS, a short, hernia-specific quality-of-life questionnaire, is easy to use and well accepted by patients. It is shown to be a feasible instrument to evaluate patient reported outcome after day-case hernia surgery in a web-based multicentre quality assurance system.

Evaluation of the use of digital images for a national prostate core external quality assurance scheme

To evaluate the use of virtual images as an alternative to glass slides to expand the number of participants in the External Quality Assurance Scheme for prostatic biopsies. Benign and neoplastic cases, previously circulated as glass slides, were selected to include cases that had demonstrated a high level of agreement (n = 10) and a lesser degree of agreement (n = 10). Whole slide virtual images were circulated to 68 pathologists; 51 responses were returned. The levels of agreement for the primary diagnosis and for Gleason grading of cancers were analysed using kappa statistics. Responses for glass slides versus images were compared for the 24 pathologists for whom data were available. Levels of agreement for diagnostic categories using virtual slides were moderate to substantial, comparable to those found using glass slides. The level of agreement for Gleason grades 8-10 was substantial, but for lower grades was fair or moderate, poorer than for the glass slide circulation. Circulation of virtual images of biopsy material is a suitable alternative to glass slide-based schemes for the evaluation of diagnostic consistency. The majority of participants agreed that the ability to evaluate limited diagnostic material outweighed the disadvantages of a virtual system.

EGFR and KRAS quality assurance schemes in pathology: generating normative data for molecular predictive marker analysis in targeted therapy

IntroductionThe aim of this study was to compare the reproducibility of epidermal growth factor receptor (EGFR) immunohistochemistry (IHC), EGFR gene amplification analysis, and EGFR and KRAS mutation analysis among different...

Students and the Governance of Higher Education in Norway

The article discusses the question of student participation in higher education governance at the national and the institutional levels in Norway. Two ideal-type perspectives on governance are developed in order to illuminate the Norwegian case: a democratic perspective and a market perspective. The article provides a brief overview of the historical development of student participation in higher education governance, emphasizing how students view their own role in the governance arenas in which they participate. Close attention is paid to student participation and influence in quality assurance schemes at both the national and the institutional levels. In the conclusion, the article discusses how the recent developments are changing the balance towards the market model of higher education governance, without obliterating significant elements of the hitherto predominant democratic governance model.

External Quality Assessment Scheme for Biological Monitoring of Occupational Exposure to Toxic Chemicals

ObjectivesIn this study, we summarized the External Quality Assessment Scheme (EQAS) for the biological monitoring of occupational exposure to toxic chemicals which started in 1995 and continued until a 31st round robin in the spring of 2010. The program was performed twice per year until 2009, and this was changed to once a year since 2010. The objective of the program is to ensure the reliability of the data related to biological monitoring from analytical laboratories.MethodsOne hundred and eighteen laboratories participated in the 31st round robin. The program offers 5 items for inorganic analysis: lead in blood, cadmium in blood, manganese in blood, cadmium in urine, and mercury in urine. It also offers 10 items for organic analysis, including hippuric acid, methylhippuric acid, mandelic acid, phenylglyoxylic acid, N-methylformamide, N-methylacetamide, trichloroacetic acid, total trichloro-compounds, trans,trans-muconic acid, and 2,5-hexanedione in urine. Target values were determined by statistical analysis using consensus values. All the data, such as chromatograms and calibration curves, were reviewed by the committee.ResultsThe proficiency rate was below 70% prior to the first round robin and improved to over 90% for common items, such as PbB and HA, while those for other items still remained in the range of 60-90% and need to be improved up to 90%.ConclusionThe EQAS has taken a primary role in improving the reliability of analytical data. A total quality assurance scheme is suggested, including the validation of technical documentation for the whole analytical procedure.

Results of a Pilot External Quality Assurance Scheme for Somatic EGFR Mutation Testing in Non-Small Cell Lung Cancer Managed by EMQN, ESMO, ESP, and ETOP

77 Stratified HR (95% CI) 0.87 (0.73-1.05) 1.02 (0.59-1.77) 0.71 (0.54-0.94) Stratified LRT p-value 0.14 0.95 0.01 Median OS (pmab + CT vs CT), mos

Measuring interobserver variation in a pathology EQA scheme using weighted κ for multiple readers

BackgroundA Urological Pathology External Quality Assurance (EQA) Scheme in the UK has reported observer variation in the diagnosis and grading of adenocarcinoma in prostatic biopsies using basic κ statistics, which...

Quality Beef Schemes and Consumer Perception

Meat quality is currently conditioned to the fulfilment of different requirements concerning food safety and other ethic and social aspects. Nevertheless, restrictions and other considerations spreading faster than the above mentioned aspects could be applied in order to gain higher consumer satisfaction, which is to say, a higher quality. On the other hand, many different studies point to the existence of important shifts that manifest the need to increase the knowledge about consumer preferences and the fundamental need to support product differentiation by means of a quality labelling or different quality assurance schemes. This work analyzes different strategies related to the beef quality in a Spanish region (Castile and Leon), guaranteeing such quality with the presence of a quality labelling or a particular distinctive or brand, at the same time that some aspects concerning consumer behaviour behind beef quality are manifested. Data coming from the statistical treatment of different interviews are complemented with the information supplied by other secondary information sources, in order to construct the theoretical model to identify the main strategies to perform to promote the consumption of this product.

The Norwegian front‐end governance regime of major public projects

PurposeThe purpose of this paper is to present a theoretically based analysis and evaluation of the Norwegian quality assurance scheme (QA1 and QA2) for major public projects (MPPs), drawing on a number of different perspectives from organization theory and decision‐making theory, but also from insight from two major public reform waves – new public management (NPM) and post‐NPM. The purpose is to analyze the scheme as a governance system, focusing on the way of organizing the decision system. Two illustrative cases are also analyzed where the QA system is used.Design/methodology/approachThe theory used in the article is taken from decision‐making theory, including an economic‐rational, an instrumental‐structural and a garbage can perspective, but also from reform theory and studies. The quality assurance scheme in Norway is first outlined, followed by a presentation and application of decision‐making theory on the system, and then a discussion of the elements from reform waves in the system. Method is interviews and public documents. The paper is also based on a pilot study that the author has done together with a consulting firm, covering three MPPs and an ongoing analysis of 23 MPPs.FindingsA structural‐instrumental perspective gives the best insight into the complex design of the QA system, which encompasses both centralizing elements with the potential to increase political control, and devolutionary elements, such as the use of private experts, while an economic‐rational perspective helps to explain the technical planning ideal. The garbage can perspective highlights complexity, potential ambiguity and the use of symbols. In a second step, the article shows that the QA system's approach to planning and the inclusion of external experts is very much inspired by NPM reform thinking, the QA1 part of the system, which anchors the system in the central political leadership and thus potentially increases political control, is a typical post‐NPM element. The two cases illustrate both how the political executive can use the QA system to increase control, that the consultants play a mainly supportive role and that MPP as about many other aspects than the one central for a QA system.Originality/valueThere are very few studies of QA systems for MPPs that are using decision‐making theory and reform theory in this way. Many MPP studies are of a technical and economic character, while the study described in this paper very much digs into the political considerations build into such systems and their balancing towards other concerns and interests. Designing QA system will, accordingly, be much more a political issue and not a technical and economical one.