Mandatory Quality Research Articles

Conservation Rates of Breast and Axilla Indicate the Quality of Surgical Management of the Early-Stage Breast Cancer Patient

Background: Multidisciplinary care in quality-assured specialized Brest Centre (BC) is nowadays considered optimal management of breast cancer and is associated with better patient outcomes. Modern breast cancer surgery should provide optimal oncological outcomes and preserve the quality of life. European Society of Breast Cancer Specialists (EUSOMA) set up the minimum requirements for a specialized BC and a set of 15 mandatory quality indicator (Q.I.) benchmarks for BC certification purposes. Six Q.I. are intended for breast cancer surgery quality assessment. Methods: In BC of Clinical Hospital Centre Rijeka, data were collected retrospectively for 2019 and prospectively thereafter in a clinical register, encrypted according to the EUSOMA instructions and uploaded into collective EUSOMA database. Following database validation, all Q.I. were calculated for our BC for 3 consecutive years. In addition, a comprehensive on-site audit was performed in 2021 for all services included in breast cancer management in Rijeka. Results: All mandatory surgical Q.I. were above the EUSOMA benchmarks in all 3 years. Non-compliance with EUSOMA recommendations were reported as major, minor, recommendations and observations. For BC surgical department, no major or minor non-conformities were reported. At the national level, mastectomy rates were above the permitted EUSOMA benchmark in 4 consecutive years. Conclusion: We have voluntarily initiated and performed quality control of our BC. The certificate obtained is a confirmation of the high quality of care. Concerning the mastectomy rate in Croatia, other centres should consider quality evaluation to determine the status of detected suboptimal surgical management.

Systematic review on the effects of the physical and social aspects of community pharmacy spaces on service users and staff.

Aim:This systematic review aimed to provide new insights into how pharmacy spaces, or the architecture of pharmacies, are experienced by pharmacy service users and staff. The review sought to identify environmental factors which may influence service users’ and staff participation in community-based pharmacy health services.Method:Ten databases were searched for English language publications, using a combination of search terms relating to pharmacy service users and staff; pharmacy spaces; and health and social care outcomes. Data from the final selected studies were extracted, thematically analysed using a narrative approach and the quality of each study assessed using the Integrated quality Criteria for the Review of Multiple Study designs (ICROMS).Results:80 articles reporting 80 studies published between 1994 and 2020 were identified; they were from 28 countries, involving around 3234 community pharmacies, 13,615 pharmacy service users, 5056 pharmacists and 78 pharmacy health staff. Most studies (94%) met the ICROMS minimum score, and half did not meet the mandatory quality criteria. Four themes likely to influence service users’ and staff experiences of pharmacy health services were identified: (1) privacy; (2) experience of the physical environment; (3) professional image; and (4) risk of error.Conclusion:To optimise the delivery and experience of pharmacy health services, these spaces should be made more engaging. Future applied research could focus on optimising inclusive pharmacy design features.

A106 THE EPIDEMIOLOGY OF COMPLEX COLONIC POLYPS: A POPULATION BASED STUDY OF THE SOUTHWEST ONTARIO COLONOSCOPY COHORT

BackgroundComplex polyps are well recognized amongst endoscopists, but its definition varies in the literature and from one endoscopist to another. Despite its clinical importance, the epidemiology of complex polyps is poorly understood.AimsTo assess the epidemiology of complex polyps on a population level, and in FIT positive individuals.MethodsThe Southwest Ontario Colonoscopy cohort is a prospective database consisting of all adult patients undergoing colonoscopy at 21 hospitals in Southwest Ontario. Data is collected through a mandatory quality assurance form completed by the endoscopist after each procedure. All outpatient adult colonoscopies for any indication were included. Incomplete colonoscopies, repeat procedures, and poor preparation colonoscopies were excluded. A manual review of the colonoscopy report was completed in cases where the description of the complex polyps was missing. The primary outcomes were the prevalence of complex polyps in the cohort, and in FIT positive patients. Secondary outcomes include endoscopic description of the complex polyp, rates of attempted and complete resection, and identification of possible associations between patient and endoscopist factors with complex polyp detection and removal. A multivariate logistic regression model was generated to assess for factors associated with complex polyp detection.ResultsFrom February 2019 to December 2020, 43389 colonoscopies were included, of which 1459 were for FIT positive patients. 2294 patients had a complex polyp, with a prevalence of 5.3% [95% CI 0.051–0.055], while the prevalence was 17.1% [95% CI 0.152–0.191] in the FIT positive cohort. Compared to average-risk patients undergoing colonoscopy for colon cancer screening, the odds ratio (OR) of detecting a complex polyp in individuals with positive FIT was 4.12 [95% CI 3.42–4.98, p<0.0001]. Among complex polyps,1324 (57.7%) were described as large (>2cm) and 1290 (56%) described as sessile. Of 2294 patients with complex polyps,1992 (86.8%) [95% CI 0.855–0.882] underwent a removal attempt, with successful complete removal as determined by the endoscopist achieved in 1905 patients (95.6%) [95% CI 0.947–0.965]. Compared to gastroenterologists, general surgeons and internists were less likely to detect a complex polyp, OR 0.67 [95% CI 0.61–0.73, p <0.0001] and 0.36 [95% CI 0.20–0.67, p=0.0011] respectively. Trainee involvement was associated with higher rate of complex polyp detection, OR 1.20 [95% CI 1.07–1.35, p=0.0022]. Females were less likely to have a complex polyp compared to males, OR 0.71 [95% CI 0.65–0.77, p<0.0001].ConclusionsComplex polyps are more prevalent than previously reported in the literature, with a high prevalence among the FIT positive population compared to other indications of colonoscopy.Funding AgenciesNone

A71 POLYP TO ADENOMA CONVERSION FACTOR AS A SURROGATE FOR ADENOMA DETECTION RATE-– FINDINGS FROM THE SOUTHWEST ONTARIO COLONOSCOPY COHORT

BackgroundThe adenoma detection rate (ADR) is one of the main quality indicators of a colonoscopy but requires combining endoscopic and histologic data. However, the polyp detection rate (PDR) requires only endoscopic assessment and has been proposed as a proxy measure for the ADR.AimsTo calculate a conversion factor for PDR to ADR, for use as a future surrogate of ADR when only PDR is available.MethodsThe Southwest Ontario Colonoscopy cohort consists of all outpatient colonoscopies performed across 20 hospitals in Southwestern Ontario between April 2017 and February 2018. Data was collected prospectively through a mandatory quality assurance form that was completed after each procedure and pathology reports were manually reviewed. Endoscopies with associated histologic findings were included.The PDR and true ADR were calculated for each physician. A weighted polyp to adenoma detection rate quotient (APDRQ) was calculated, weighting each physician’s APDRQ by the number of procedures performed. The APDRQ was determined for all outpatient procedures and specifically for screening/surveillance indications.ResultsDuring the study period, 57 endoscopists performed 31,721 colonoscopies. The overall PDR was 41.1% and the ADR was 26.5%. The weighted ADPDRQ was 0.638 (95% CI: 0.600, 0.675). When limited to screening/surveillance colonoscopies, the weighted ADPDR was 0.616 (95% CI: 0.564, 0.669). To better understand the influence of endoscopists with low ADR: PDR, we excluded those with ratio below (<2 standard errors) the average, which resulted in greater ADR: PDR for all colonoscopies 0.695 (95% CI: 0.679, 0.711) and for screening/surveillance colonoscopies and 0.692 (95% CI: 0.677, 0.707).ConclusionsIn this large, population-based, cohort study, we calculated the ADR; PDR ratio. We propose this may be used in future studies to infer ADR when only PDR is available. Scatter plot of correlation between ADR and PDR, by physician. The dashed line indicates the line for which ADR=PDR, the maximum value the ADR can take for a given PDR. The marker size is proportional to the number of colonoscopies performed.Funding AgenciesNone

NASA’s Black Marble Multiangle Nighttime Lights Temporal Composites

In addition to the daily Black Marble products (VNP46A1/A2), the recently released temporal composite products (VNP46A3/A4) are generated from daily high-quality, atmospheric, and lunar-Bidirectional Reflectance Distribution Function (BRDF) corrected, Visible Infrared Imaging Radiometer Suite (VIIRS) Day/Night Band (DNB) nighttime radiances (VNP46A2). This letter describes the algorithm of NASA&#x2019;s Black Marble monthly and annual (VNP46A3/A4) Nighttime Light (NTL) composites that are operationally produced for multiple view angle categories and snow conditions, along with ancillary metrics and mandatory quality assurance flags. Boxplot metrics are calculated to systematically remove outliers and minimize reliance on empirical or regional thresholds. VNP46A3/A4 products represent all nighttime conditions (i.e., moon-lit and moon-free periods), leading to an increased number of high-quality observations. To fully make use of the VIIRS DNB&#x2019;s wide-swath (3040 km), both VNP46A3/A4 are generated for three view zenith angle categories (near-nadir, off-nadir, and all-angles) and two different snow conditions (snow-free and snow-covered). The introduction of global multidirectional data should be of interest to the scientific and applications communities. In particular, they can enable standardized intercomparisons across NTL products and allow a greater capability to track additional dimensions of NTL change, including the intrinsic characteristics of human settlements and their infrastructure. VNP46A3/A4 products are currently made available retrospectively via NASA&#x2019;s Level-1 and Atmosphere Archive and Distribution System (LAADS) from the start of the Suomi-National Polar-orbiting Partnership (S-NPP) mission period (c. January 2012).

Abstract PO-078: Introduction of implicit bias training to oncology faculty as a quality improvement initiative

Abstract Background: In a review, Hall (2015) found that implicit bias was significantly related to patient-provider interactions and health outcomes. Implicit Bias Training is a tool to help individuals understand and take corrective action for unfair behaviors. Purpose: Our goal was to assess physician attitudes towards Implicit Bias Training and to measure physician participation in the training when implemented as an NCCN quality measure. Methodology: Implicit Bias Training was offered by the DEI Office at Yale-New Haven Health. This incentivized quality initiative was required for all practicing oncologists. Of 109 physicians, 45 (41.3%) completed this training. The anonymous survey, which included a link to the Harvard Implicit Project's Implicit Association Test (IAT), was emailed to the 45 oncologists prior to participation in the session. There were 21 respondents (46.7% response rate). Results: The self-reported results of the IAT are as follows: 9.5% (n=2) report a strong automatic preference for European Americans (EA) vs. African Americans (AA). 23.8% (n=5) report a moderate automatic preference for EAs vs. AAs 42.9% (n=9) reported little to no automatic preference between AAs vs. EAs. 4.8% (n=1) report a slight automatic preference for AAs vs. EAs. 19% (n=4) did not participate in the IAT. 33.3% (n=7) of physicians report being either extremely or moderately surprised by the result of their IAT, while 33.3% (n=7) report being neither surprised nor unsurprised. 14.3% (n=3) report being moderately unsurprised, and the remainder did not respond. Physicians were asked to report their enthusiasm about Implicit Bias Training on a scale of 0 to 10. The Mean was 6. While physician enthusiasm reports show polarization not apparent by the mean, 57.1% (n=12) of physicians report being hopeful or very hopeful that training would help to improve both collegial and patient-physician relationships. Conclusion: Though this was a mandatory quality initiative that was incentivized, participation was less than 50%. Explanations for the observed participation rate are multifactorial and nuanced. Of the 17 respondents who completed the IAT, nearly one-half (n=7) reported strong or moderate bias for one racial group, and 41% report being surprised by their result. Our findings suggest that unconscious bias was demonstrated in a significant percentage of participants, many of whom were surprised by their results. The results support the need for Implicit Bias Training as part of ongoing oncology quality improvement. 57% of participating physicians were optimistic that the initiative would lead to positive changes. Future Work: We postulate that bias training could increase awareness and result in improved communication with minority patients. Our next project will evaluate the effect of Implicit Bias Training on minority participation in clinical trials. Inclusivity and representation in clinical trials is paramount in efforts to democratize cancer care and our study suggests that bias training could be a valuable tool to achieve this goal. Citation Format: Renee C. Taylor, Andrea Silber. Introduction of implicit bias training to oncology faculty as a quality improvement initiative [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-078.

Comparison of Innovation in the Electronic Banking Services of the Largest Slovak Banks

At the time of digitization, the requirements of consumers are constantly increasing. Systematization of scientific sources and approaches and implemented surveys prove that new requirements impact the development of electronic innovations, which have also appeared in the banking sector. The digitization of provided banking services also represents innovations focusing on creating environmentally friendly innovations. Moreover, electronic banking has been used by clients of commercial banks for several years, as it represents easy access to finance, their overview, and other e-banking advantages. The opportunity to use the home environment is irreplaceable for many people. Wasting paper while providing banking operations in a brick-and-mortar branch or spending valuable time standing in a crowd of the bank’s clients is an unacceptable idea for many people, especially in the situation caused by the COVID-19 pandemic. This paper compares the electronic banking services of the three largest Slovak banks using the Kano model. The Kano model, through 5 categories of perceived quality by customers, expresses the relationship between their degree of satisfaction and quality attributes. These categories include one-dimensional, attractive, mandatory, reverse, and indifferent attributes of products creating quality. The individual categories of perceived quality change in accordance with the life cycle. They pass from indifferent through attractive, one-dimensional to the category of mandatory quality attributes. This paper focuses on selected types of provided services and innovations in electronic banking, drawing attention to the perception of risk by Slovak bank clients. The authors pointed out the differences among the services offered in individual banks provided within the portfolio of their services and the identification of customer requirements. The findings showed that the customers have not largely mastered the innovations, but they are nevertheless very important from the future perspective. The results of the research could be useful for bank managers to find the best way how to approach clients who approach innovations in banking with distrust and reluctance to adopt them.

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study.

We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR). All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9. Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates.

Ten Years of Improving Acute Stroke Management in a Metropolitan Area: A Population-Based Quantification of Quality Indicators

Background and Purpose: Rapid access to acute stroke treatment improves clinical outcomes in patients with ischemic stroke. We aimed to shorten the time to admission and to acute stroke treatment for patients with acute stroke in the Hamburg metropolitan area by collaborative multilevel measures involving all hospitals with stroke units, the Emergency Medical Services (EMS), and health-care authorities. Methods: In 2007, an area-wide stroke care quality project was initiated. The project included mandatory admission of all stroke patients in Hamburg exclusively to hospitals with stroke units, harmonized acute treatment algorithms among all hospitals, repeated training of the EMS staff, a multimedia educational campaign, and a mandatory stroke care quality monitoring system based on structured data assessment and quality indicators for procedural measures. We analyzed data of all patients with acute stroke who received inhospital treatment in the city of Hamburg during the evaluation period from the quality assurance database data and evaluated trends of key quality indicators over time. Results: From 2007 to 2016, a total of 83,395 patients with acute stroke were registered. During this period, the proportion of patients admitted within ≤3 h from symptom onset increased over time from 27.8% in 2007 to 35.2% in 2016 (p < 0.001). The proportion of patients who received rapid thrombolysis (within ≤30 min after admission) increased from 7.7 to 54.1% (p < 0.001). Conclusions: Collaborative stroke care quality projects are suitable and effective to improve acute stroke care.

Non-Financial Disclosure and Corporate Financial Performance Under Directive 2014/95/EU: Evidence from Italian Listed Companies

This paper investigates the impact of Directive 2014/95/EU on both the quantity and quality of non-financial disclosure (NFD) and its relationship with corporate financial performance (CFP) in 20 Italian listed companies. The current study considers both the annual reports (AR) and social and environmental reports (SER) released two years prior (2015–2016) and two years after (2017–2018) the Directive’s application. A manual content analysis was conducted and OLS regression analyses were carried out to evaluate the relationship between NFD and CFP, measured by ROA, ROE and Tobin’s Q. The findings show that the Directive affected the quantity of NFD, but not the quality, and that a transfer of information occurred from the different reporting mediums considered. Overall, NFD quality is significant and positively associated with CFP when measured by ROA and ROE, however, the mandatory NFD quality following the Directive does not show a significant relationship with CFP.

Quality assurance data for regional drip-and-ship strategies- gearing up the transfer process

BackgroundStroke patients with large vessel occlusion (LVO) require endovascular therapy (EVT) provided by comprehensive stroke centers (CSC). One strategy to achieve fast stroke symptom ‘onset to treatment’ times (OTT) is the preclinical selection of patients with severe stroke for direct transport to CSC. Another is the optimization of interhospital transfer workflow. Our aim was to investigate the dynamics of the OTT of ‘drip-and-ship’ patients as well as the current ‘door-in-door-out’ time (DIDO) and its determinants at representative regional German stroke units.MethodsWe determined the numbers of all EVT treatments, ‘drip-and-ship’ and ‘direct-to-center’ patients and their median OTT from the mandatory quality assurance registry of the federal state of Hesse, Germany (2012–2019). Additionally, we captured process time stamps from primary stroke centers (PSC) in a consecutive registry of patients referred for EVT in our regional stroke network over a 3 months period.ResultsAlong with an increase of the EVT rate, the proportion of drip-and-ship patients grew steadily from 19.4% in 2012 to 31.3% in 2019. The time discrepancy for the median OTT between ‘drip-and-ship’ and ‘direct-to-center’ patients continuously declined from 173 to 74 min. The largest share of the DIDO (median 92, IQR 69–110) is spent with the organization of EVT and consecutive patient transfer.Conclusions‘Drip-and-ship’ patients are an important and growing proportion of stroke patients undergoing EVT. The discrepancy in OTT for EVT between ‘drip-and-ship’ and ‘direct-to-center’ patients has been reduced considerably. Further optimization of the DIDO primarily aiming at the processes after the detection of LVO is urgently needed to improve stroke patient care.

PO-1100 Implementation of FAST-Forward during COVID19: Report of acute skin toxicity /resource implications

Purpose or Objective In March 2020, a 1-week hypofractionated adjuvant breast radiotherapy schedule, 26 Gy in 5 fractions was adopted to reduce the risk of COVID 19 exposure for patients and staff without compromising on cancer outcomes. This study aimed to confirm acceptable acute toxicity rates for patients receiving this 1-week schedule (+/- sequential boost) and to quantify the positive impact of implementing this schedule on linac capacity. Materials and Methods This is a multicentre prospective observational study of consecutive patients receiving 26 Gy in 5 fractions adjuvant breast cancer radiotherapy (+/- boost) Mar-Aug 2020. Consensus was obtained on planning procedure protocols which included dose-volume evaluation and mandatory radiation quality assurance objectives. Standardised virtual consultations assessed acute skin toxicity during treatment and at weeks 1, 2, 3 and 4 post treatment using CTCAE V5 scoring criteria. Toxicity was compared between patients who received a boost and those that did not. The total number of linac minutes saved was estimated accounting for boost and DIBH use Results In total, 135 women were included, 33 (24%) received a boost. 128/135 (95%) patients, including 31/33 boost patients, completed at least 3/5 acute toxicity assessments. 0/128 (0%) reported moist desquamation not confined to skin folds or minor bleeding (grade 3 toxicity). 41/128 (31%) reported brisk erythema, moist desquamation confined to skin folds or breast swelling (Grade 2) and 63/128 (50%) reported faint erythema or dry desquamation (Grade 1) as their worst reported acute skin toxicity. The highest prevalence of grade 2 toxicity occurred at week 1 following treatment (19.5%), which reduced to 2.6% by week 4. There was no statistically significant difference in acute toxicity between boost and no boost patients (p= 1.00). Delivering a 1-week schedule to 135 patients over a six month period led to a saving of 21,300 linac minutes and 1485 hospital visits compared to delivering a moderately hypofractionated regimen of 3 weeks duration. 6,300 LINAC minutes were saved and 462 hospital visits avoided for patients > 70 years and cocooning under national guidance $Φg $Φg Conclusion This study demonstrates the feasibility of rapidly implementing a 1-week hypofractionated adjuvant breast radiotherapy schedule in clinical practice and how this landmark change has a considerable impact on linac capacity. This change in practice has ensured ongoing access to treatment for patients during the COVID-19 pandemic and greatly reduced the risks of infection for patients and staff. It further confirms acceptable acute skin toxicity even when followed by boost.

The Problem of DNA/RNA Contamination in the Laboratory during PCR Testing for COVID-19

Introduction. When conducting PCR (polymerase chain reaction) testing of biospecimens for SARS-CoV-2 RNA at the beginning of the COVID-19 pandemic, the laboratory service in Russia and foreign countries encountered problems related to the accuracy of diagnostics and obtaining false negative, false positive, and dubious results. The objective of this work was to analyze current literature on the problem of false positive and dubious results of RT-PCR testing for COVID-19. Material and methods. We selected Russian and foreign English-language publications devoted to organization of laboratory diagnostics of the novel coronavirus disease, challenges of PCR testing for SARS and MERS, and general issues of DNA contamination in a PCR laboratory for 2012–2020. We also reviewed current regulations and guidelines for COVID-19 diagnostic testing. Results. The analysis of factors leading to contamination of specimens with nucleic acids in the laboratories performing massive COVID-19 PCR testing during the pandemic showed that the main reasons for contamination included a large number of tests, accumulation of samples in the laboratory, and the increased amount of wastes containing amplification products. Cross-contamination occurs due to technical errors in the course of laboratory manipulations at the stages of sample preparation and inactivation, RNA isolation, and addition of cDNA/RNA or positive control samples to the reaction mixture. Pollution of laboratory working areas with amplicons arising from the opening of tubes and plates containing PCR products is the main cause of total contamination in the laboratory. Signs of cross-contamination include the increase in the proportion of positive samples with low threshold cycle values and detection of a positive signal from negative control samples at RNA isolation and amplification stages. A positive result for all samples in a round, including negative control samples, is a marker of “total contamination” in the laboratory. In addition to contamination, formation of nonspecific PCR products at late reaction cycles and nonspecific fluorescence of the reaction mixture, which occurs when reagent storage temperatures are not observed, may also lead to false positive results. Conclusion. To prevent contamination in a PCR laboratory, strict control over the flow of test samples and medical wastes, regular analysis of the frequency of positive test results, and mandatory laboratory quality control of testing and DNA/RNA contamination are compulsory.

Cross-evaluation of a parallel operating SVM – CNN classifier for reliable internal decision-making processes in composite inspection

In the aerospace industry, automated fibre laying processes are often applied for economical composite part fabrication. Unfortunately, the current mandatory visual quality assurance process takes up to 50% of the entire manufacturing time. An automised classification of manufacturing deviations using Neural Networks potentially improves the inspection's effectiveness. Unfortunately, the automated decision-making procedures of machine learning approaches are challenging to trace. Therefore, we introduce an approach for evaluating the classifiers response for this use case.For this purpose, we present a parallel classification approach of Convolutional Neural Network (CNN) and Support Vector Machine (SVM) with suitable intermediate checking stages between both classification processes. The particular novelty of this study is this intermediate comparison to trace the behaviour of the two classifiers along their image processing chains and to project the results back to the input image.With respect to the SVM, we analyse their extracted input features via t-Distributed Stochastic Neighbor Embedding calculations and parallel coordinates plots. Moreover, the classification score of the SVM as well as the feature vector distances within the SVM are investigated. For the CNN, the outputs of its first joined convolutional layer are correlated with the raw input images of different classes using Structural Similarity Index Measure metrics. Additionally, also the CNN's classification rates are analysed. Accordingly, a suitable uncertainty confidence interval for the CNN is determined on the bases of its neural activations. Finally, the relevance of individual pixels for the CNN decision is determined through Smooth Integrated Gradients and linked to the manually extracted image features for the SVM Classifier.The results of this paper are particularly valuable for developers and users of visual inspection systems in safety-critical domains.

Reappraisal of Quality Indicators in the Blood Center of a Tertiary Care Teaching Hospital - Are We Ready for Accreditation?

Background and Objectives: Ensuring quality in transfusion services has become an essential part of the hospital quality management system to provide safe blood supply to the patients. To assess the overall quality performance of our blood center, this study was conducted to evaluate the five mandatory quality indicators (QI) put forward by the National Accreditation Board for Hospitals and Healthcare Providers (NABH) and make recommendations, if any, for improvement of the same. Methods: The five mandatory QIs (defined by NABH) were observed and monitored monthly for a period of 1 year from April 2019 to March 2020, information was gathered in a structured manner, root causes for any deviation were analyzed, and specific corrective and preventive actions were taken. Results: The overall performance was found to be satisfactory with the mean transfusion-transmitted infection % being 1.82%, mean transfusion reaction rate 0.30%, and mean wastage rate 13.5%. The turnaround time was maintained at 28.5 min for emergency cases and 141.38 min for routine. There was no case of component quality control failure during the study period. Conclusion: The study observed that by strictly following the quality parameters put forward by NABH, processes can be controlled in a manner that errors are avoided or kept at minimum. This, in turn, shall help in attaining higher levels of performance. The study concluded by putting forward few important recommendations.

A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities.

Background:Blood transfusion services (BTS) in India have progressed significantly during the last three decades. However, there is still inequity in the availability and access to blood due to various demand and supply-side issues. Appropriate laws, regulations, policies, and guidelines are critical to ensure universal access to blood.Aims and Objectives:This article aims to review the evolution and current status of legal, regulatory, and policy framework and analyses the issues, challenges, and opportunities for improvement of BTS in India.Methods:This article is based on an extensive review of currently available literature and government documents.Results:The review highlights the gaps and challenges in terms of licensing, safety and quality, voluntary blood donations, the organization of BTS, access to services, and regulatory bodies. The findings emphasize the need for a coordinated response by either the National Blood Transfusion Council or a newly established autonomous “National Blood Authority” consisting of technical, administrative, and legal experts which must be exclusively responsible for regulating the BTS. As adherence to quality management systems in blood banks is not a mandatory requirement, it recommends a legal measure to ensure mandatory quality assurance in blood banks and storage centers. Towards ensuring efficiency and universal access to blood, this article recommends evidence-based criteria for establishing new blood banks to avoid skewed distribution of blood banks, component separation facilities, and blood storage centers.Conclusion:The review emphasizes the need for periodic reviews and updates of the legal, regulatory and policy framework, considering the rapid developments and technical advancements with increasingly complex systems and processes in transfusion medicine.

Relative Influences of Review and Engagement Auditor Rotation on Audit Quality: Evidence from China

Manuscript type: Research paper Research aims: This study focuses on the effects of audit partner rotation on audit quality (AQ) in China. In particular, we examine the effects of review auditors (RAs) and engagement auditors (EAs) on AQ when they voluntarily and mandatorily rotate. Design/Methodology/Approach: The data in this study are retrieved from the Chinese Stock Market and Accounting Research (CSMAR) database. We develop an OLS regression model and logit model respectively to test the hypotheses developed. Finally, we have 13,856 firm-year observations collected for the first regression model, and 16,893 firm-year observations gathered for the second logit model from 2003 to 2015. Research findings: Findings show that RAs are more likely to behave opportunistically to retain clients by weighing up the benefits and costs of compromising audit quality in the first year after a rotation. The results imply that RAs may have an incentive to acquiesce the clients’ accounting irregularities in their first year of audit engagement when they are mandatorily rotated. However, we do not find this trend in terms of EAs’ rotation, suggesting that EAs are less affected by the auditor-client relationship compared to RAs. In addition, we find that RAs are less likely to issue modified audit opinions (MOPI) as the magnitude of negative discretionary accruals (DA) increases when they are voluntarily rotated. Theoretical contribution/Originality: Previous studies have investigated the relationship between mandatory audit partner rotation and audit quality. The results are mixed and inconclusive. Our study contributes to the extant literature by considering RAs’ opportunistic behaviour after mandatory rotation, which has not been explored in previous studies. In China, only a few studies have examined the relationship between mandatory audit partner rotation and audit quality. Our study is one of the first study focusing on the RA’s influence on AQ. Practitioner/Policy implication: The findings of our study can help Chinese authorities, listed firms and academics gain more understanding on whether mandatory audit partner rotation improves audit quality in practice. Since RAs have greater incentive to retain the existing client, we propose that RAs should bear more responsibility for the audit work, instead of the equally shared responsibility with EAs. Research limitation/Implications: Our study is subject to some limitations. First, our study adopts the performance-adjusted discretionary accruals as a proxy for audit quality. However, there can be a measurement error in estimating discretionary accruals. Second, we focus on the auditor rotation and exclude the case of audit firm rotation. Since the AQ can be affected by various factors, audit firm rotation can also affect AQ. Third, although we test the relative effects of RAs and EAs in audit work, we do not examine the effect of RAs’ characteristics such as their professional experience, educational background, and years of service. AQ can be affected by RAs’ characteristics.

Changes in Dialysis Center Quality Associated With the End-Stage Renal Disease Quality Incentive Program : An Observational Study With a Regression Discontinuity Design.

In 2012, the Centers for Medicare & Medicaid Services started levying performance-based financial penalties against outpatient dialysis centers under the mandatory End-Stage Renal Disease Quality Incentive Program. To determine whether penalization was associated with improvement in dialysis center quality. Leveraging the threshold for penalization (total performance score< 60), a regression discontinuity design was used to examine the effect of penalization on quality over 2 years. Publicly available Medicare data from 2015-2018 were used. The effect of penalization at dialysis centers with different characteristics (for example, size or chain affiliation) was also examined. United States. Outpatient dialysis centers (n= 5830). Dialysis center total performance scores (a composite metric ranging from 0 to 100 based on clinical quality and adherence to reporting requirements) and individual measures that contribute to the total performance score. There were 1109 (19.0%) outpatient dialysis centers that received penalties in 2017 on the basis of performance in 2015. Penalized centers were located in ZIP codes with a higher average proportion of non-White residents (36.4% vs. 31.2%; P< 0.001) and residents with lower median income ($49290 vs. $51686; P< 0.001). Penalization was not associated with improvement in total performance scores in 2017 (0.4 point [95% CI, -2.5 to 3.2 points]) or 2018 (0.3 point [CI, -2.8 to 3.4 points]). This was consistent across dialysis centers with different characteristics. There was also no association between penalization and improvement in specific measures. The study could not account for how centers respond to penalization. Penalization under the End-Stage Renal Disease Quality Incentive Program was not associated with improvement in the quality of outpatient dialysis centers. None.

Pitfalls of rubella serology while on the brink of elimination: evaluation of national data, Belgium, 2017

BackgroundIn Belgium, rubella serology is frequently requested in women of childbearing age, despite high vaccination coverage and a near-absence of congenital rubella cases. Different test kits are available and should be standardised by an international standard preparation.AimTo analyse and compare rubella serology practices in Belgian laboratories.MethodsAs part of the mandatory External Quality Assessment programme for rubella serology in Belgium, the national public health institute, Sciensano, sent a voluntary questionnaire concerning anti-rubella IgM/IgG analyses in women aged 15 to 45 years in 2017 to 130 laboratories.ResultsThe questionnaire response rate was 83.8% (109/130). The majority of 169,494 IgG analyses were performed on Roche (55%), Abbott (17%) and Diasorin (13%) analysers. Not all laboratories used the proposed international cut-off of 10 IU/mL. Assumed median seroprevalence ranged from 76.3% with Liaison (Diasorin) to 96.3% with Modular (Roche). Despite very low rubella incidence in Belgium, 93 laboratories performed 85,957 IgM analyses, with 748 positive and 394 grey zone results. The National Reference Centre for Measles, Mumps and Rubella virus and the National Reference Centre for Congenital infections did not confirm any positive rubella cases in 2017.ConclusionThis retrospective analysis shows that rubella serology results may differ considerably according to the assay used. It is therefore important to use the same test when comparing results or performing follow-up testing. The number of anti-rubella IgM analyses was very high. Incorrect use of IgM for screening women of childbearing age can lead to unwarranted anxiety and overuse of confirmation tests.

The impact of nurse staffing levels on nursing-sensitive patient outcomes: a multilevel regression approach

The goal of this study is to provide empirical evidence of the impact of nurse staffing levels on seven nursing-sensitive patient outcomes (NSPOs) at the hospital unit level. Combining a very large set of claims data from a German health insurer with mandatory quality reports published by every hospital in Germany, our data set comprises approximately 3.2 million hospital stays in more than 900 hospitals over a period of 5 years. Accounting for the grouping structure of our data (i.e., patients grouped in unit types), we estimate cross-sectional, two-level generalized linear mixed models (GLMMs) with inpatient cases at level 1 and units types (e.g., internal medicine, geriatrics) at level 2. Our regressions yield 32 significant results in the expected direction. We find that differentiating between unit types using a multilevel regression approach and including postdischarge NSPOs adds important insights to our understanding of the relationship between nurse staffing levels and NSPOs. Extending our main model by categorizing inpatient cases according to their clinical complexity, we are able to rule out hidden effects beyond the level of unit types.