21. Complaints, Grievances, and Ombudsmen

Quality control and quality assurance procedures at the THOR BNCT facility

Appropriate quality assurance (QA) and quality control (QC) procedures have been well developed and validated for dual X-ray absorptiometry (DXA), and are widely applied in multicenter clinical trials to monitor device stability used to check the treatment effects on bone mineral density. This is not yet the case for quantitative ultrasound (QUS) technology, for which no QC approaches have yet been fully tested. The first Achilles (GE-Lunar Corporation, Madison, WI, USA) has been on the market for 10 years (1991). The goal of this study was to develop the QC methodology for the QUS Achilles+ device using its past/current experience (log and maintenance files.) as well as by integrating the progress made over the last years in the ultrasound domain so as to better understand the influence of temperature on ultrasound parameters. Because of the lack of confidence in the external black rubber phantom used in daily QC with the Achilles+, to monitor the device stability, we selected several QC parameters known to be influenced by potential malfunctions as experienced by the maintenance department of GE-Lunar company as well as the physical approach. These are phantom temperature-adjusted speed of sound (PSOS-TC) and broadband ultrasound attenuation (PBUA-TC), water speed of sound error (WSE), water spectrum slope (WSS) and water gain (WG). We used four Achilles+ devices perfectly stable during their entire QC range, to calculate the optimum thresholds (based mostly on 95% confidence interval) for each of these parameters as well as the precision for the in vitro SOS and BUA. An additional not fully stable Achilles device has been used to run a QC procedure example. The precision expressed as the CV was 0.22% and 0.65% for the PSOS-TC and PBUA-TC, respectively. The alarm thresholds used for QC process are +/- 0.6%, +/- 1.9%, +/- 6.8 m/s, +/- 5.3% and +/- 7.3% for the PSOS-TC, PBUA-TC, WSE, WSS and WG, respectively. Applying a logical approach on the impact of each parameter on each other as well as their respective reactivity to malfunctions, we build a QC process flowchart meant to detect real malfunction in the daily QC. We found that in case of real malfunctions, the in vivo SOS should be decreased by 1.33 m/s for each 1 m/s increase in WSE. Unfortunately, in vivo BUA can not be adjusted when real malfunction occurs. Nevertheless, the BUA can be qualified as bad quality data and excluded from the medical interpretation. Using the currently available phantom and parameters, the best possible QC procedures to detect long-term drift in the daily QC of the Achilles+ was developed. To fully validate our approach and gain confidence in the defined limits it is our plan to apply this QC processing to a higher number of QUS devices.

Reservoir fluid properties play a key role in the design and optimization of production processes and facilities for efficient reservoir management. Inaccurate and unreliable fluid characterization leads to high uncertainties in in-place hydrocarbon volume estimates, negatively impacting ultimate recovery predictions and hence the asset value. Obtaining reliable PVT properties of reservoir fluids starts with the acquisition of adequate volumes of representative fluid samples followed by PVT data measurement and phase behavior modeling. Subsequent laboratory analysis should be monitored through established quality control procedures to provide high quality data. The fluid characterization methodology should employ best-practice techniques to model fluid behavior as functions of pressure, temperature, and fluid composition. In this paper, we discuss key steps in sampling and fluid characterization for a wide spectrum of fluid types ranging from extra-heavy oils to lighter gas-condensates including complex near-critical fluids. Using several field examples, sampling tool design and procedures for obtaining representative samples are discussed. Laboratory fluid analysis strategies for various fluid types are highlighted with an emphasis on employing quality control and quality assurance procedures. The importance of special PVT tests to capture fluid behavior under different production strategies ranging from simple depletion to complex tertiary recovery is emphasized. Application of recommended fluid modeling techniques such as C7+ characterization and Gibb's energy minimization are demonstrated through field examples.

This chapter reviews basic principles of electrophoresis, the types of apparatus that are available, quality control and quality assurance procedures, and costs involved with the procedure and provides a wide variety of patterns with recommended interpretations. Electrophoresis of serum and urine in the clinical laboratory takes advantage of the fact that each protein has its own unique structure. The first studies of serum protein electrophoresis were performed entirely in a fluid-based system devised by Arne Tiselius, winner of the 1948 Nobel Prize in Chemistry, called moving boundary electrophoresis. An early-morning void collected into a container without preservative is adequate for screening for the presence of monoclonal free light chains. Each protein electrophoresis gel should have an internal control sample run on it. The percentage of protein in each fraction should be recorded and compared day to day. Good quality assurance requires coordination of all available laboratory information for the patient. A file is set up for the patient the first time that an M protein is detected in the serum or in the urine. In patients with cirrhosis, synthesis of hepatocyte-derived proteins such as albumin and transferrin is decreased. In protein-losing enteropathy, damage to the gastrointestinal tract such as occurs in gluten-losing enteropathy (celiac disease), the serum demonstrates findings similar to those of the nephritic syndrome with hypoalbuminemia, hypogammaglobulinemia, and occasionally elevated levels of α2 macroglobulin. The urine immunofixation is compared to the urine protein electrophoresis to determine which band is the monoclonal free light chains (MFLC).

SUMMARY During the months immediately preceding the implementation of the 1991 Criminal Justice Act the Home Office commissioned a study of quality assurance and quality control procedures used by probation services in their work on social inquiry reports and in their preparation for the change to pre-sentence reports. This paper summarizes the results of that study, which included a survey of current practice in probation services and the development of a quality control instrument for assessing the quality of pre-sentence reports. It is emphasized that the views expressed in this paper are those of the authors and not necessarily those of the Home Office. THE BACKGROUND TO THE STUDY The 1991 Criminal Justice Act introduced substantial changes in the reports provided to sentencers by probation officers in England and Wales. The familiar 'social inquiry report' (SIR) was replaced by the Pre-Sentence Report (PSR), which was intended to concentrate on the circumstances of and reasons for the current offence and, wherever appropriate, on the identification of a 'community sentence' which might help offenders to stay out of trouble in future. Previous patterns of offending were to be covered in so far as they assisted an understand ing of the current offence, and the whole report was to be informed by consideration of the seriousness of the offence so that discussion of a possible sentence could concentrate on those outcomes which were

Point-of-care testing (POCT) is the analysis of patient specimens outside the clinical laboratory, near or at the site of patient care, usually performed by clinical staff without laboratory training, although it also encompasses patient self-monitoring. It is able to provide a rapid result near the patient and which can be acted upon immediately. The key driver is the concept that clinical decision making may be delayed when samples are sent to the clinical laboratory. Balanced against this are considerations of increased costs for purchase and maintenance of equipment, staff training, connectivity to the laboratory information system (LIS), quality control (QC) and external quality assurance (EQA) procedures, all required for accreditation under ISO 22870. The justification for POCT depends upon being able to demonstrate that a more timely result (shorter turnaround times (TATs)) is able to leverage a clinically important advantage in decision making compared with the central laboratory (CL). In the four decades since POCT was adapted for the self-monitoring of blood glucose levels by subjects with diabetes, numerous new POCT methodologies have become available, enabling the clinician to receive results and initiate treatment more rapidly. However, these instruments are often operated by staff not trained in laboratory medicine and hence are prone to errors in the analytical phase (as opposed to laboratory testing where the analytical phase has the least errors). In some environments, particularly remote rural settings, the CL may be at a considerable distance and timely availability of cardiac troponins and other analytes can triage referrals to the main centers, thus avoiding expensive unnecessary patient transportation costs. However, in the Emergency Department, availability of more rapid results with POCT does not always translate into shorter stays due to other barriers to implementation of care. In this review, we apply the principles of evidence-based laboratory medicine (EBLM) looking for high quality systematic reviews and meta-analyses, ideally underpinned by randomized controlled trials (RCTs), looking for evidence of whether POCT confers any advantage in clinical decision making in different scenarios.

ATLAS (A Toroidal LHC ApparatuS) is a general purpose experiment, which will start its operation at the Large Hadron Collider (LHC) at CERN in 2007. The ATLAS detector is designed to study the products of proton-proton collisions at c.m.s. energies of up to 14 TeV. Three Greek universities have taken the responsibility to construct 112 BIS-MDT (barrel inner small) chambers using 29000 drift tubes of /spl sim/1.7 m length that have been quality tested before assembly. This paper describes the quality assurance and quality control (QA/spl I.bar/QC) procedures for the monitored drift tubes (MDT), followed at the High Energy Physics Laboratory of the National Technical University of Athens. The quality parameters verification and the obtained results are presented.

As an evolution of the successful DMC II digital camera series, Leica Geosystems has introduced the Leica DMC III digital aerial camera using, for the first time in the industry, a large-format CMOS sensor as a panchromatic high-resolution camera head. This paper describes the Leica DMC III calibration and its quality assurance and quality control (QA/QC) procedures. It will explain how calibration was implemented within the production process for the Leica DMC III camera. Based on many years of experience with the DMC and DMC II camera series, it is know that the sensor flatness has a huge influence on the final achievable results. The Leica DMC III panchromatic CMOS sensor with its 100.3mm x 56.9mm size shows remaining errors in a range of 0.1 to 0.2μm for the root mean square and shows maximum values not higher that 1.0μm. The Leica DMC III is calibrated based on a 5cm Ground Sample Distance (GSD) grid pattern flight and evaluated with three different flying heights at 5cm, 8cm and 11cm GSD. The geometric QA/QC has been performed using the calibration field area, as well as using an independent test field. The geometric performance and accuracy is unique and gives ground accuracies far better than the flown GSD.

Two terms that have gained traction in the academia and policy making are Digital Transformation and Sustainable Development of public and private organizations. Digital transformation can be defined as the increasing application of digitization and automation that has important impacts on the structure of business ecosystems and their products and services. The core of Digital Transformation is the overall digitization and cross-linking of the value creation process. On the other hand, Sustainable Development has been defined as “the ability to meet the needs of the present without compromising the ability of future generations to meet their own needs” (Brundtland, et al., 1987). As it can be observed, the two terms are defined in a vague way, however, their practical importance cannot be overstated. Despite the lack of a unified definition and methodological framework on how to define them, public and private organizations are making efforts to incorporate them in their practices. Consequently, the purpose of the current paper is to map the opinions of employers, employees, policy makers, academics and students on what Digital Transformation and Sustainable Development mean for themselves and their organization. To achieve the objective of the paper, a survey was developed and disseminated across Europe. The questionnaire contained questions on the process of Digital Transformation and Sustainable Development themselves, what the respondents think of and fear about those two terms, what are barriers and finally what skills are missing that their organization faces in their effort to achieve Digital Transformation and Sustainable Development. Initial results include the following: Missing skills by the employers and managers was considered the main internal barrier for achieving Digital Transformation and Sustainable Development on an organization. Finally, a series of statistical tests is performed to examine the synergies between Digital Transformation and Sustainable Development. For example, we wanted to investigate whether the answer to the question of whether the organization has experienced difficulties in finding appropriate people to achieve Digital Transformation is independent of the answer to the same question for Sustainable Development. The respondents that consider that their organization has difficulties in finding appropriate people for Digital Transformation are likely to answer that they face the same difficulty for Sustainable Development. Consequently, since there is an overlap between those skills, training people could offer a double advantage for any organization.

This article seeks to evaluate leadership styles—transformational, transactional, and laissez-faire—across the manufacturing and service sectors and at different organizational levels—senior management, middle management (supervisor), and junior level—to understand how these styles affect employees’ performance in public and private organizations in Guyana. Many studies have been conducted on leadership; however, there is a gap regarding the most appropriate leadership style for organisations to adopt to positively impact employees’ performance and contribute to the sustainable growth and development of the organisation. Moreover, a comparison between private and public organisations revealed that private organisations consistently outperform public organisations, as shown in parliamentary reports on public agencies and the published financial reports of privately owned organisations. The leadership styles examined by this study are hoped to bring clarity and set the stage for future studies.

Antibody tests have been extensively used to monitor the prevalence and changes in the HIV-1 epidemic in the general population. In the UK, unlinked anonymous testing of neonatal dried blood spot (DBS) samples has provided unbiased estimates of the prevalence of maternal infection in women with live births [1]. Quality assurance and quality control procedures are necessary to ensure consistent tests resulting in unbiased estimates of prevalence in population-based surveys. As part of the quality assurance programme for neonatal screening laboratories, Centers for Disease Control and Prevention (CDC, Atlanta, USA) has produced blinded (negative and positive) samples which have been sent to laboratories worldwide for 25 years [2]. In addition, CDC has supplied HIV-1-positive quality control DBS specimens produced to a set standard to measure assay performance. As part of the national unlinked anonymous surveillance programme covering the former Thames regions of England [3], we have received HIV-1 quality assurance samples every quarter and quality control samples every 6 months for over 20 years, and have a 100% record of correctly identifying HIV-1 antibody-positive DBS CDC quality assurance samples. In total, we have tested over 3.5 million neonatal DBS samples for HIV-1 maternal antibody. DBS samples are eluted overnight at 4°C in phosphate-buffered saline-Tween 80 and sodium azide (0.0005%). These eluted samples are then tested by making a 1 : 5 dilution in Treponema pallidum particle agglutination (TPPA) buffer into a V-well test plate and adding a 1 : 10 dilution of Serodia HIV-1 gelatin particles (Fujirebio Inc., Tokyo, Japan). After settlement for 4 h at room temperature, the plates are read over a light box, a positive result being shown by a characteristic agglutination pattern, and a negative result by a button of settled particles. Positive samples are titrated to an end point. Although DBS samples containing HIV-1 antibodies have been reported to be stable over time, even in unsuitable climatic and storage conditions [4,5], to our knowledge, no study has re-analysed them after a period of more than 5 years [6]. The stability of DBS samples over longer periods could prove useful for retrospective testing of antibodies for other conditions using long-term stored DBS samples [7]. To analyse antibody stability, we selected the oldest available DBS samples and eluates stored in our laboratory and re-tested them for HIV-1 antibodies. Firstly, we examined four DBS CDC quality control high positive control samples produced in 1991 and stored continuously in a freezer at −20°C in gas-impermeable bags with a dessicant. When tested in February 2014, all of them had the same titres as those measured in 1991. Secondly, we retested 12 DBS samples produced between October 1997 and October 1999 by the CDC quality assurance programme. The samples had been stored at 4°C in a laboratory fridge for at least 14 years and were originally tested when they reached our laboratory. They were re-tested in November 2013 and all 12 samples were HIV-positive; nine had the same titre, two increased by two dilutions, and one decreased by two dilutions. Finally, we re-tested 98 HIV-1-positive neonatal DBS eluates available from the unlinked anonymous anti-HIV-1 survey in pregnant women in North Thames which were originally tested in the first three quarters of 2003 and stored for over 9 years at −20°C. As we were interested in antibody degradation, we selected the DBS eluates with the lowest titres among the oldest specimens stored in our laboratory. When re-tested in March 2014, all remained positive for HIV-1 antibody. In 67 samples, titres remained unchanged, there was one dilution decrease in 1 sample, and an increase between 1 and 5 dilutions in 30 samples; the latter changes may be due to variations in testing conditions. In conclusion, these findings suggest that, over long periods, HIV-1 antibody concentration does not deteriorate in DBS samples stored at 4 and −20°C, or in eluates stored at −20°C. This implies that archived DBS samples could be reliably used in retrospective studies on HIV and potentially other infections. Acknowledgements We are grateful to the Laboratory Quality Assurance and Standardization Programs, Division of Laboratory Sciences, CDC for providing the quality assurance and quality control specimens used in this letter. D.W. curated the samples and carried out the testing. All authors contributed to the final draft and approved it. We are grateful to the Health Protection Agency (now Public Health England), and to the Welton Foundation for additional funding. The UCL Institute of Child Health receives a proportion of funding from the Department of Health's National Institute for Health Research Biomedical Research Centres funding scheme. Conflicts of interest There are no conflicts of interest.

The aim of this study was to assess time management skills of managers employed in public and private organization and examine the role of demographic variables on the time management skills of both public and private sector groups. The methodology entails a survey of 60 managers i.e. 30 from public organizations and 30 from private organizations, were selected randomly for the present study in Udaipur city, India. An online questionnaire technique was used for data collection. Secondary data was also used to get a better insight into the research problem. Frequency, percentage, mean weighted score were used for analysis of data, Results showed that majority of respondents were males, in 35-45 years age group and had 11- 20 years experience.Managers had excellent time management skills in both public and private organization i.e. 60 per cent and 80 per cent, respectively. Overall mean weighted score for time management skills were same in both private organization and public organizations. The major limitation of this study is that it was conducted in Udaipur city alone, while the work culture of organizations other than in Udaipur city may be different.

Proponents of new public management (NPM) expect public organizations to become more flexible and adaptive after administrative reforms, effectively showing convergence with patterns of organizational change in the private sector. This “convergence argument” is tested with a sample of 61 public and 61 private organizations in the Netherlands. We analyze whether public organizations, after 20 years of NPM reform, have changed their organizational structures and internal policies in relation to competitive, regulatory, and autonomy pressures, similarly to private organizations. Statistical analyses show that competition increases the incidence of change both in public and private organizations. High managerial autonomy and exposure to regulatory pressures relate to increased incidence of change in public organizations, but not in private ones. The results support the idea that NPM reform has made public organizations more similar to private organizations but that some concrete differences persist between private and public management in the Netherlands.

Over the past 10 years, the Peruvian National Tuberculosis (TB) Program, the National Reference Laboratory (NRL), Socios en Salud, and US partners have worked to strengthen the national TB laboratory network to support treatment of multidrug-resistant TB. We review key lessons of this experience. The preparation phase involved establishing criteria for drug susceptibility testing (DST), selecting appropriate DST methods, projecting the quantity of DST and culture to ensure adequate supplies, creating biosafe laboratory facilities for DST, training laboratory personnel on methods, and validating DST methods at the NRL. Implementation involved training providers on DST indications, validating conventional and rapid first-line DST methods at district laboratories, and eliminating additional delays in specimen transport and result reporting. Monitoring included ongoing quality control and quality assurance procedures. Hurdles included logistics, coordinating with policy, competing interests, changing personnel, communications, and evaluation. Operational research guided laboratory scale-up and identified barriers to effective capacity building.

Veterinary clinical trials generate data that advance the transfer of knowledge from clinical research to clinical practice in human and veterinary settings. The translational success of non-regulated and regulated veterinary clinical studies is dependent upon the reliability and reproducibility of the data generated. Clinician-scientists that conduct veterinary clinical studies would benefit from a commitment to research quality assurance and best practices throughout all non-regulated and regulated research environments. Good Clinical Practice (GCP) guidance documents from the FDA provides principles and procedures designed to safeguard data integrity, reliability and reproducibility. While these documents maybe excessive for clinical studies not intended for regulatory oversight it is important to remember that research builds on research. Thus, the quality and accuracy of all data and inference generated throughout the research enterprise remains vulnerable to the impact of potentially unreliable data generated by the lowest performing contributors. The purpose of this first of a series of statement papers is to outline and reference specific quality control and quality assurance procedures that should, at least in part, be incorporated into all veterinary clinical studies.