Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)

Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/- 10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P = 0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation. Crown Copyright (C) 2003 Published by Elsevier Science Ltd. All rights reserved.

Quality assurance of paediatric cardiac surgery: A prospective 6-year analysis

Objective: To audit effective quality assurance methods to monitor outcomes following paediatric cardiac surgery at a single institution. Methods: All patients undergoing cardiac surgery from January 1996 to December 2001 were enrolled prospectively. Patients were stratified by complexity of surgical procedure into four groups, with Category 4 being the most complex procedure. Outcome measures included death, length of admission and morbidity from complications. Results: A total of 1815 patients underwent 1973 surgical procedures. Of these, 1447 (73.3%) were cardiopulmonary bypass procedures, and 543 (27.5%) were more complex (Category 3 and 4) procedures. Median patient age was 3.5 years (range, 1 day-20 years) and patient weight 15.0 kg (range, 900 g to 90 kg). Sixty-six patients (3.6%) died during the study period. Of the procedures in 1996, 22.7% were classified as complex compared with 29.2% of procedures in 2001. The annual surgical mortality ranged from 1.9-4.7% (P=0.20), and when mortality was adjusted for complexity of surgery, there was no significant yearly variation in the mortality rate (P=0.57). Analysis of individual surgeon's results showed no significant difference in the mortality rate by complexity of surgery performed (P=0.90). Mean ventilation times did not change significantly over time (P=0.79). The yearly incidence of significant neurological complications ranged from 0.6% to 4.5% and the incidence of arrhythmias from 4.2% to 8.0%. No difference was detected between the years. Conclusions: Stratifying complexity of surgery proved valuable in monitoring surgical outcomes and detecting differences in performance over time as large subgroups were created for analysis.

Skin cancer medicine in primary care: towards an agenda for quality health outcomes

The number of skin cancer clinics functioning within Australia's primary care environment is increasing rapidly, and significant concerns have been raised about the type and quality of work done by some doctors in some clinics. Mainstream general practice is threatened by perceived fragmentation, and specialist practice in dermatology and plastic surgery is threatened by encroachment into their domains of practice. We propose an agenda of training, standards, accreditation, audit and research to ensure that skin cancer clinics provide optimal health outcomes for patients.

External audit in the National Health Service in England and Wales:a study of an oversight body's control of auditor remuneration

In the National Health Service (NHS) in England and Wales an oversight body, the Audit Commission (AC), defines the scope of the external auditors’ work, appoints the auditors and has oversight of their fees and audit quality. This heavily regulated audit regime mitigates some of the deficiencies observed in high profile corporate failures. Independence, it has been argued, is influenced by the total auditor remuneration paid by the client. In this study we examine total auditor remuneration in a regulated market which seeks to ensure audit independence and audit quality. In particular we undertake rigorous analysis of auditor remuneration by the type of auditor: We place emphasis on the differentiation between private sector firms and the AC’s in-house auditors (District Audit). Individual private audit firms charge premiums (up to 16%) for particular audit work in identified locations, but no premiums were found when we examined total auditor remuneration. The regime appears to permit efficient operation of the audit market while safeguarding both audit independence and standards.

An empirical investigation of audit pricing in the public sector:the case of Greek LGOs

This paper investigates the associations between audit pricing and multidimensional characteristics of local governments by using a sample of Greek municipalities. The Greek institutional setting is interesting because it is politically pluralistic. Moreover, independent auditors appointed through a bid process exclusively perform the audits. Our results suggest a considerable variation on audit fees which is mainly driven by politically related factors indicating the importance of relevant theoretical anticipations in audit pricing in the public sector. Agency costs appear strong enough to explain audit pricing. We also confirm prior findings on the significance of audit complexity and size. Results also suggest that audit fees are reduced when an internal team dedicated to accrual accounting is appointed. Therefore, our conclusions offer practical implications for policy setters and regulators in the public sector in relation to audit quality.

Related party transactions, corporate governance and accounting quality in Greece

Related Party Transactions (RPTs) have been considered recently in research as a phenomenon which is associated with several financial scandals, shareholder’s wealth expropriation and is used for earnings management (EM) purposes by the reporting entity. This study aimed to: (i) assess the extent of EM and RPTs i Greece; (ii) investigate the association between RPTs and EM; (iii) investigate the association between corporate governance and EM; (iv) investigate the association between corporate governance and RPTs; and (v) investigate the impact of RPTs on Accounting Quality. Greece was selected for this study as it provides a special context due to poor investor protection, high levels of EM and unhealthy financial reporting environment where wealth extraction and EM are more likely. This study examines the relationship between earnings management and RPTs for the firms listed on the Athens Stock Exchange (ASE). Moreover, it examines the association between earnings management and corporate governance activities. The results show a negative and significant relationship between EM and RPTs. This finding does not support the conclusion that RPTs are necessarily conducted to mask fraud or the extraction of firm resources. The results show that firms audited by one of the Big 4 audit firms are associated with less EM. Additionally, the study investigates the relationship between RPTs and accounting quality. The findings show that that there is no significant difference in accounting quality between RPTs firms and non-RPTs firms. This study contributes to the EM, accounting quality and corporate governance literatures. This research suggests recommendations for researchers, data providers and policy makers on ways to reduce the problems associated with RPTs.

Shareholder ratification of the auditor and audit market competition

In my dissertation, I examine factors associated with firms’ submission of auditor selection for shareholder ratification and test if shareholder ratification of auditor selection is associated with the extent of price competition in the audit market (as measured by audit fees) and audit quality (as measured by clients’ earnings management). The dissertation is motivated from the recent recommendation of the U.S. Treasury’s Advisory Committee on Auditing Profession (ACAP) regarding the submission of auditor selection for shareholder ratification votes. The ACAP suggests that this practice may improve the competition in the audit market; yet, there is no empirical evidence supporting the ACAP’s recommendation. My dissertation attempts to fill the gap in the literature on an issue of current interest to the auditing profession. I find that firm size, CEO-Chair duality, insider ownership and institutional ownership are associated with the submission of auditor selection for shareholder ratification vote. However, I do not find an association between audit committee variables and the submission of auditor selection for shareholder ratification vote. The second essay investigates the association between auditor ratification and audit fees. Audit fees are higher in firms that submit auditor selection for shareholder ratification. The finding is not consistent with the increased price competition predicted by the ACAP. The third essay of my dissertation examine whether the submission of auditor selection for shareholder ratification is associated with earnings management. I find that firms that submit auditor selection for shareholder ratification are more likely to have lower level of earnings management. Overall, the results suggest that the same factors that are associated with higher quality monitoring also may be associated with the submission of auditor selection for shareholder ratification vote. The results call into question the one-size-fits-all approach recommended by the ACAP.

An empirical analysis of the global audit market: International Financial Reporting Standards-related changes and differences within the Big 4 global networks

Ongoing debates within the professional and academic communities have raised a number of questions specific to the international audit market. This dissertation consists of three related essays that address such issues. First, I examine whether the propensity to switch between auditors of different sizes (i.e., Big 4 versus non-Big 4) changes as adoption of International Financial Reporting Standards (IFRS) becomes a more common phenomenon, arguing that smaller auditors have an opportunity to invest in necessary skills and training needed to enter this market. Findings suggest that clients are relatively less (more) likely to switch to (away from) a Big 4 auditor if the client's adoption of IFRS occurs in more recent years. ^ In the second essay, I draw on these inferences and test whether the change in audit fees in the year of IFRS adoption changes over time. As the market becomes less concentrated, larger auditors becomes less able to demand a premium for their services. Consistent with my arguments, results suggest that the change in audit service fees declines over time, although this effect seems concentrated among the Big 4. I also find that this effect is partially attributable to a differential effect of the auditors' experience in pricing audit services related to IFRS based on the period in which adoption occurs. The results of these two essays offer important implications to policy debates on the costs and benefits of IFRS adoption. ^ In the third essay, I differentiate Big 4 auditors into three classifications—Parent firms, Brand Name affiliates, and Local affiliates—and test for differences in audit fee premiums (relative to non-Big 4 auditors) and audit quality. Results suggest that there is significant heterogeneity between the three classifications based on both of these characteristics, which is an important consideration for future research. Overall, this dissertation provides additional insights into a variety of aspects of the global audit market.^

Shareholder Ratification of The Auditor and Audit Market Competition

In my dissertation, I examine factors associated with firms’ submission of auditor selection for shareholder ratification and test if shareholder ratification of auditor selection is associated with the extent of price competition in the audit market (as measured by audit fees) and audit quality (as measured by clients’ earnings management). The dissertation is motivated from the recent recommendation of the U.S. Treasury’s Advisory Committee on Auditing Profession (ACAP) regarding the submission of auditor selection for shareholder ratification votes. The ACAP suggests that this practice may improve the competition in the audit market; yet, there is no empirical evidence supporting the ACAP’s recommendation. My dissertation attempts to fill the gap in the literature on an issue of current interest to the auditing profession. I find that firm size, CEO-Chair duality, insider ownership and institutional ownership are associated with the submission of auditor selection for shareholder ratification vote. However, I do not find an association between audit committee variables and the submission of auditor selection for shareholder ratification vote. The second essay investigates the association between auditor ratification and audit fees. Audit fees are higher in firms that submit auditor selection for shareholder ratification. The finding is not consistent with the increased price competition predicted by the ACAP. The third essay of my dissertation examine whether the submission of auditor selection for shareholder ratification is associated with earnings management. I find that firms that submit auditor selection for shareholder ratification are more likely to have lower level of earnings management. Overall, the results suggest that the same factors that are associated with higher quality monitoring also may be associated with the submission of auditor selection for shareholder ratification vote. The results call into question the one-size-fits-all approach recommended by the ACAP.

Audit Tendering in the UK: A Review of Stakeholders’ Views

This study reports the results of a content analysis of the comment letters sent to the UK Financial Reporting Council (FRC), in response to its consultation document on the 2012 revisions of the UK Corporate Governance Code, concerning the proposal for mandatory audit tendering. The results indicate a general support for the FRC’s proposals with a number of key concerns related to audit quality, auditor independence and audit cost. There is also clear conflict of interests among some stakeholder groups such as audit firms and companies on one side and institutional investors on the other side. There is evidence of conflict of interest between Big 4 and non-Big 4 audit firms. Implications for future consultations and legislations are also discussed.

Addressing the theory practice gap in nurse education: evaluating teaching through audit against NMC standards and final management placement

Introduction
This paper outlines an innovative approach to auditing and evaluating the content of a management and leadership module for undergraduate nursing students after their final management clinical placement. Normally evaluations of teaching in a module take place at the end of a teaching module and therefore do not properly reflect the value of the teaching in relation to practical clinical experience.
Aim
This audit and evaluation sought to explore both the practical value of the teaching and learning, and also the degree to which it the teaching reflected against the NMC Standards of Education and Learning (2010 domain 3).
Methods
Having piloted the evaluative tool with an earlier cohort of nursing students, this evaluation explored both a quantitative assessment employing a Personal Response System (n =172), together with a qualitative dimension (n=116), thus delivering paper-based comments and reflections from students on the value and practicality of the module teaching theory to their final clinical management experience. The quantitative audit data were analysed for frequencies and cross tabulation and the qualitative audit data were thematically analysed.
Results
Results suggest a significant proportion of the students, appreciated the quality of the standard of teaching, but more importantly, ‘valued or highly valued’ the teaching and learning in relation to how it helped to significantly inform their management placement experience. A smaller proportion of the students underlined limitations and areas in which further improvement can be made in teaching and learning to the module.
Conclusion
Significantly positive evaluation by the students of the practical value of teaching and learning, to the theoretical management module. This has proved a useful auditing approach in assessing the theoretical teaching to student’s Level 3 clinical experience, and facilitated significant recommendations as far as developing the teaching and learning to better reflect the practice needs of nursing students

Validation of stress indicators for the assessment of animal welfare and prediction of pork meat quality variation at commercial level

Les procédures appliquées avant l’abattage des animaux influencent directement la qualité de la viande en modulant l’état physiologique des porcs; ainsi, l’augmentation de la température corporelle, les taux élevés de lactate sanguin et l’épuisement des réserves de glycogène entre autres, occasionnent la majorité des baisses de qualité. L’objectif de cette thèse était de valider des outils indicateurs de stress porcin pour les fermes et les abattoirs. Ceux-ci seraient appliqués à la surveillance du bien-être animal et à la prédiction de variation de qualité de la viande porcine au niveau commercial. Premierement, les résultats de la thèse ont permis de conclure qu’un des outils développés (analyseur portatif de lactate) mesure la variation du niveau de lactate sanguin associé à l’état physiologique des porcs dans la phase péri-mortem et aide à expliquer la variation de la qualité de la viande chez le porc à l’abattoir, en particulier dans les muscles du jambon. Deuxièmement, les résultats des audits du bien-être animal appliqués de la ferme à l’abattoir ont démontré que la qualité du système d’élevage à la ferme d’origine et les compétences du chauffeur de camion sont d’importants critères affectant la réponse comportementale des porcs à la manipulation avant l’abattage. Ces résultats ont également démontré que les conditions de logement à la ferme (la faible densité et l’enrichissement dans les enclos), le comportement des porcs en période pré-abattage (glissade), ainsi que les interventions du manipulateur (utilisation du bâton électrique) dans la zone d’étourdissement de l’abattoir affectent négativement la variation de la qualité de la viande. L’application des protocoles d’audits dans la filière porcine a également démontré que le respect des critères de bien-être animal fixés par un outil de vérification est primordiale et permet de contrôler les conditions de bien-être des porcs à chaque étape de la période pré-abattage, de produire une viande de qualité supérieure et de réduire les pertes. Les audits de bien-être animal sont donc un outil qui apporte des resultats très pertinents pour aider a éviter les variations de la qualité de la viande chez le porc. Troisièmement, la thermographie infrarouge s’est avéré être une technique prometteuse permettant d’évaluer la variation de température corporelle de l’animal pendant et après un stress physique, en particulier lorsque cette mesure est prise derrière les oreilles. En conclusion, les outils validés à travers cette thèse représentent des méthodologies non invasives et potentiellement complémentaires à d’autres approches d’évaluation de l’état physiologique et du bien-être animal par rapport au stress, permettant de réduire les pertes de qualité de viande (par exemple en utilisation conjointe avec le niveau de lactate sanguin et les indicateurs de stress comportemental, entre autres).

Product quality and compliance in the pharmaceutical industry

This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.

Equipment quality control

Mammography equipment must be evaluated to ensure that images will be of acceptable diagnostic quality with lowest radiation dose. Quality Assurance (QA) aims to provide systematic and constant improvement through a feedback mechanism to address the technical, clinical and training aspects. Quality Control (QC), in relation to mammography equipment, comprises a series of tests to determine equipment performance characteristics. The introduction of digital technologies promoted changes in QC tests and protocols and there are some tests that are specific for each manufacturer. Within each country specifi c QC tests should be compliant with regulatory requirements and guidance. Ideally, one mammography practitioner should take overarching responsibility for QC within a service, with all practitioners having responsibility for actual QC testing. All QC results must be documented to facilitate troubleshooting, internal audit and external assessment. Generally speaking, the practitioner’s role includes performing, interpreting and recording the QC tests as well as reporting any out of action limits to their service lead. They must undertake additional continuous professional development to maintain their QC competencies. They are usually supported by technicians and medical physicists; in some countries the latter are mandatory. Technicians and/or medical physicists often perform many of the tests indicated within this chapter. It is important to recognise that this chapter is an attempt to encompass the main tests performed within European countries. Specific tests related to the service that you work within must be familiarised with and adhered too.

Are joint audits associated with higher audit fees?

In its October 2010 Green Paper on audit policy, the European Commission suggested that joint audits might be a way of improving the audit market in Europe. However, some parties consider that a joint audit system is not an efficient solution because the perceived improvements in audit quality, if any, are not commensurate with the significant increase in audit fees. We compare audit fees paid during the years 2007-2011 by listed companies in France, where joint audits are mandatory, with those paid by British and Italian companies. Theory suggests that audit fees in countries with high investor protection, such as the UK, are likely to be greater than those in countries with lower investor protection, such as France and Italy, ceteris paribus. However, we find significantly higher audit fees in France after controlling for well-documented auditor, client, and engagement attributes, which vary across countries. Furthermore, since we do not find statistically significant differences in the magnitude of abnormal accruals, the higher audit fees observed in France do not appear to be associated with higher audit quality.