Explore the vast range of titles available.

Objectives: To describe and evaluate a laboratory-based nursing education activity on transfusion to improve patient safety, an often-neglected opportunity. Methods: Our transfusion service developed a day-long \"Blood School\" to provide knowledge, skills, and behaviors to nurses in four aspects of transfusion: blood ordering, sample collection, transfusion procedures, and recognition and reporting of transfusion reactions. We collected survey data on methods and effects of training and hard data on the number of reported patient safety events. Results: Nurses want more hands-on experience to understand transfusion concepts, practice hospital procedures, recognize latent problems, and have behaviors to act effectively. We observed that engagement and understanding are best where participation is highest. Reported patient safety events were lower even as self-reported nursing mistakes increased. Conclusions: Blood School is a well-received and effective site for nursing education in transfusion. We seek ways to extend and improve laboratory-based nursing training to improve patient safety. Key Words: Patient blood management; Transfusion safety; Laboratory-based educational outreach; Laboratory corrective and preventive action (CAPA)

Abstract Objectives Transfusion-transmitted bacterial infection (TTBI) from platelet components is likely underrecognized and can be fatal. Twenty-four-hour prospective culture was felt to be insufficiently preventive after multiple TTBIs occurred and strategies to improve safety were sought. Methods Two fatal and one severe TTBIs occurred from a split-apheresis platelet donation contaminated with Klebsiella pneumoniae. Improvement opportunities were identified and corrective and preventive action (CAPA) followed. Results To mitigate bacterial contamination and improve detection sensitivity, additional prospective culture 48 hours postcollection was implemented. Since implementation, secondary cultures have caught two true positives (0.01%) missed by 24-hour culture. Bacterial testing at issue and pathogen reduction were later implemented as an added layer of safety. Conclusion While rare, TTBI is a prominent cause of morbidity and mortality from contaminated platelets. The approach to CAPA presented here may lower the risk of future transfusion-transmitted infections but must be weighed against potential added costs.

Every month in every neighborhood in Chicago, residents, teachers, school principals, and police officers gather to deliberate about how to improve their schools and make their streets safer. Residents of poor neighborhoods participate as much or more as those from wealthy ones. All voices are heard. Since the meetings began more than a dozen years ago, they have led not only to safer streets but also to surprising improvements in the city's schools. Chicago's police department and school system have become democratic urban institutions unlike any others in America. Empowered Participationis the compelling chronicle of this unprecedented transformation. It is the first comprehensive empirical analysis of the ways in which participatory democracy can be used to effect social change. Using city-wide data and six neighborhood case studies, the book explores how determined Chicago residents, police officers, teachers, and community groups worked to banish crime and transform a failing city school system into a model for educational reform. The author's conclusion: Properly designed and implemented institutions of participatory democratic governance can spark citizen involvement that in turn generates innovative problem-solving and public action. Their participation makes organizations more fair and effective. Though the book focuses on Chicago's municipal agencies, its lessons are applicable to many American cities. Its findings will prove useful not only in the fields of education and law enforcement, but also to sectors as diverse as environmental regulation, social service provision, and workforce development.

Purpose The purpose of this paper is to investigate the influence of ISO 9001 quality improvement requirements in ISO 9001:2008, i.e. the corrective and preventive actions and internal audit, on customer satisfaction. Design/methodology/approach For the purposes of the study, data were collected via a survey on 200 aerospace and transportation companies that belong to a Canadian multinational company supply chain. The relationships between the corrective and preventive actions and internal auditing, on the one hand, and customer satisfaction, on the other, were examined via the structural equation modeling technique. Findings The major contribution of this study is that it has identified internal audit as the most influential continual improvement ISO 9001 requirement prior to the ISO 9001 transition phase, along with the corrective actions, while the preventive actions in the present formulation do not significantly influence customer satisfaction. Research limitations/implications This study is based on a cross-sectional survey conducted on the supply chain level in the aerospace and transportation sector; hence, a longitudinal study is possible as a future research avenue. The generalizability of this study’s findings is limited to similar supply chains around a multinational company consisted of companies that have at least ISO 9001 standard, but also fulfill other industry-specific requirements. Also, findings are based mainly on quality managers’ attitudes, so future studies are recommended to examine other positions’ views, too. Practical implications This research contributes to the literature and bridges the gap between theory and practice. It could be of value to both the certification bodies and the organizations that are interested in improving customer satisfaction by implementing ISO 9001 in the multinational supply chains context such as the aerospace and transportation sector. Originality/value While the influence of the ISO 9001 standard on customer satisfaction has been the subject of prior research, this is the first time that the simultaneous effect of the corrective and preventive actions and internal auditing on customer satisfaction has been studied. The validity of the removal of preventive actions from ISO 9001:2015 has also been analyzed.

National Regulatory Authorities have the responsibility of ensuring that pharmaceutical manufacturers comply with Good Manufacturing Practices (GMP) to ensure that medicinal products are consistently produced according to quality standards. Since July 2016, the EAC National Medicines Regulatory Authorities (NRAs) have been collaborating to conduct joint Good Manufacturing Practice (GMP) inspections. This study was conducted to (a) assess the joint GMP inspection procedure, (b) determine key milestones and target timelines, (c) identify areas of improvement and opportunities for capacity building, and (d) identify the contribution of the EAC joint GMP inspections in the operationalization of the African Medicines Agency (AMA). A retrospective review of the timelines for joint GMP inspections conducted from 2016 to 2022 was performed using data recorded in the EAC metric tool. Data is captured based on key milestones, including screening, scheduling joint GMP inspections, planning for joint GMP inspections, conducting physical inspections, reviewing GMP documentation, writing inspection reports, peer reviewing inspection reports, reviewing CAPAs, communicating with applicants, and issuing GMP compliance certificates. JMP was used as the statistical software to analyze the main milestones of the EAC joint GMP inspection process. The study also looked into the twinning model and joint inspections for capacity building among NRAs. Results indicated that a total of 37 pharmaceutical manufacturing facilities, located in Africa, Asia, and Europe, were jointly inspected (35 physical inspections and two desk reviews) between 2016 and 2022. The inspected facilities manufacture vaccines, non-beta-lactam tablets/capsules, sterile products, and other biologicals. Of the 37 facilities inspected, 65% (24) met EAC GMP standards and received a certificate of compliance, valid for 3 years. 8% (3) of the facilities inspected between 2018 and 2022 failed to meet GMP standards and were advised to apply for reinspection. Two facilities have not submitted corrective and preventive action (CAPA) since 2016, and three facilities have not submitted one since 2022. The study further revealed that one facility is pending joint inspection, one has been awaiting CAPA review since 2019, and one with a CAPA is still under review. Two facilities scheduled for physical inspection in 2020 could not be inspected due to COVID-19 travel restrictions. Timelines for key milestones of the joint GMP inspection process showed that overall scheduling of joint GMP inspections took more than 14 workdays, such as 57 days in 2018, 24 days in 2019, 43 days in 2020, and 28 days in 2022. Median times for planning EAC joint GMP inspections aligned with the set timelines of 30 days; however, in 2017, the median duration was 40 days. All physical inspections conducted between 2016 and 2022 were completed within the median timeline of 3 days. Nonetheless, the median time for GMP report writing in 2016 was 16 days, slightly exceeding the established timeline of 14 days. Findings also indicated that manufacturing facilities (Applicants) take a lengthy time to submit CAPA, which should be done within 90 days. Median submission times for CAPA were 135 days in 2018 and 125 days in 2019. In 2022, notable improvements were observed, with applicants submitting CAPA in a median time of 49 days. EAC GMP inspections have served as a model for building capacity in lessresourced NRAs through the twinning program. The joint inspections are carried out by two inspectors from more experienced National Regulatory Authorities (NRAs) and one inspector from less-resourced NRAs. These NRAs benefit from learning and gaining practical skills, while also building confidence and trust among themselves. This model is suitable for adoption at the continental level by the African Medicines Agency and the African Medicines Regulatory Harmonization Programme to support reliance, convergence, and harmonization. The study identified several gaps, including incomplete data in the metric tool and a lack of monitoring and recording timelines for joint GMP desk assessments. Based on the findings, the EAC region needs to establish an annual planning mechanism for joint GMP inspections and update the metric tool to include key milestones and timelines for the joint GMP desk assessment process. Enhancing the stakeholders' feedback mechanism is also essential for reducing delays in submitting corrective and preventive actions (CAPA) from facilities and shortening timelines for the joint regulatory inspection process.

RECOMMENDATIONS * DOD should develop and implement a supplier expectations policy and program to address supplier programs, such as crisis management, environmental monitoring, sanitation effectiveness monitoring, pest control, good manufacturing practices (GMPs), HACCP systems, preventive maintenance, the use of statistical process control (SPC), and verification testing, as appropriate to the individual operation. * DOD should share the information contained herein with suppliers who do not have documented and functioning food safety plans to begin the process of having them develop SPC charts to demonstrate process control and sanitary conditions.The product specification for fresh (unfrozen) raw meat and poultry should include a maximum time between slaughter and receipt by DOD. * DOD should leverage the implementation of the Food Safety Modernization Act (FSMA) legislation and regulations, requiring all suppliers that would be regulated by the U.S. Food and Drug Administration (FDA) to meet statutory and regulatory requirements as mandated by FSMA and corresponding regulatory rules. * DOD should use an information technology solution that requires all suppliers to input key data such as location, contacts, product identification, code dating and traceability program, significant hazards, audit scores, regulatory actions (e.g., equivalent to recalls, market withdrawals, and noncompliance records), SPC data, and microbiological test data.Metadata are data about the data, such as methods, sample size, analytical unit, point of sampling, and the reason the sample was collected. * DOD should incorporate evaluation of sampling schemes and SPC into audit procedures for those suppliers using the microbiological limits to assess process control and sanitary conditions. * DOD should consider enhancing diagnosis and reporting of foodborne illness and integrating this information amongst the Services to help identify potential problems within the supply chain.Received 25 July 2017/Accepted 5 September 2017/Published Online 27 December 2017 TABLE OF CONTENTS Executive Summary Recommendations Introduction: Statement of Charge to NACMCF and the Rationale for the Approach to the Charge Specific Charge to the Committee Public Health Focus Committee's Approach to Answering the Charge Scope of Committee's Work General Background: DOD Procurement Food Categories Process Flow Diagrams Principles Used in Making the Process Flow Diagrams Interpreting the Process Flow Diagrams Intended Use of the Process Flow Diagrams Manufacturing Processes and Opportunities for Loss of Process Controls Measuring Insanitary Conditions Sampling and Testing Use of Statistical Sampling Plans in the Supply Chain Finished-Product Testing to Aid in the Management and Control of Suppliers Process Control SPC Limits Process Capability SPC Monitoring via Microbiological Testing Considerations for Finished-Product Testing Sampling Plans for Screening and Auditing Suppliers Surveillance at Point of Sale Microbiological Limits and Criteria Development of Limits and Criteria Pathogens Important to Public Health Indicators that Reflect Loss of Process Control or Insanitary Conditions Comments on Microbiological Limits for Specific Food Categories Plan of Action If Limits Are Exceeded Commodity-Specific Comments on Microbiological Limits Other Indicators of Process Control and Sanitary Conditions Glossary Appendices: Available as supplemental materials References INTRODUCTION:

Sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results. The sponsor should implement a system to manage quality throughout all stages of the trial process. Quality management includes the design of efficient clinical trial protocols and tools and procedures for data collection and processing, as well as the collection of information that is essential to decision making. Every sponsor responsible for a clinical trial is required to provide independent quality assurance by means of audits. Essential features of the quality management system include clearly documented procedures, adequate training of staff, QC and QA procedures, and sound retention policies.

Prisoners of Mythis the first comprehensive history of the Tennessee Valley Authority from its creation to the present day. It is also a telling case study of organizational evolution and decline. Building on Philip Selznick's classic workTVA and the Grass Roots(1949), a seminal text in the theoretical study of bureaucracy, Erwin Hargrove analyzes the organizational culture of the TVA by looking at the actions of its leaders over six decades--from the heroic years of the New Deal and World War II through the postwar period of consolidation and growth to the time of troubles from 1970 onward, when the TVA ran afoul of environmental legislation, built a massive nuclear power program that it could not control, and sought new missions for which there were no constituencies. The founding myth of multipurpose regional development was inappropriately pursued in the 1970s and '80s by leaders who became \"prisoners of myth\" in their attempt to keep the TVA heroic. A decentralized organization, which had worked well at the grass roots, was difficult to redirect as the nuclear genii spun out of control. TVA autonomy from Washington, once a virtue, obscured political accountability. This study develops an important new theory about institutional performance in the face of historical change.

Quality can be defined as a ‘degree of excellence’ and assurance as ‘positive assertion’. Quality Assurance (QA) of a process therefore means that confidence in the outcome can be guaranteed at a pre‐defined level of quality. In transfusion, this is of prime importance and the ideal to be achieved is zero defects throughout the transfusion chain. Every laboratory must have an established internal incident reporting system as part of total quality management (TQM). This can include the use of root cause analysis (RCA) techniques when an error is detected. Organisational factors include problems associated with staffing levels and other administrative details but in general, when an error occurs, it has many contributory elements and may not be due to a single factor. When the reason(s) for the error has been determined, then corrective and preventive action (CAPA) should be implemented.

Clinical trials are designed to evaluate the efficacy, safety, or other characteristics associated with medical products. Trials are usually complex and require a large group of professionals to follow a clinical trial protocol, standard operating procedures, and study-specific manuals, guidelines, and plans. Clinical trial protocols prospectively describe the background and rationale for conducting the trial, the objectives of the trial, the trial design, the equipment to be used, the procedures to be performed, and the statistical methods on how the trial data are to be analyzed. Deviations from the protocol can result in harm to subjects, biased or inaccurate results, and possible rejection of all or part of the trial data by the sponsor or regulatory authorities. Despite preventive efforts, protocol deviations are likely to occur in most trials. This position paper proposes a common definition of protocol deviations and recommends best practices for their detection, classification, and management as part of their life cycle, with a goal of reducing their impact on subject safety and data integrity. The information contained herein is drawn globally from industry experts within the DIA Good Clinical Practice and Quality Assurance community, an industry-wide survey, and presentations with discussions at various industry meetings.