Application of HACCP for development of quality risk management in a water purification system

Abstract The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.

Streamlining an existing hip fracture patient pathway in an acute tertiary adult Irish hospital to improve patient experience and outcomes.

OBJECTIVE: To improve access for hip fracture patients to surgery within 48 h of presentation to the Emergency Department, and to increase the number of patients receiving pre-operative orthogeriatric review, through streamlining an existing hip fracture patient pathway. DESIGN: A pre-post design involving a multi-disciplinary team use of the Define, Measure, Analyse, Improve and Control framework integral to Lean Six Sigma (LSS) methodology, to assess and adapt the existing hip fracture pathway from presentation to Emergency Department to the initiation of surgery. SETTING: A 600-bed teaching hospital in Ireland. PARTICIPANTS: Nursing, medical, administrative and physiotherapy staff working across Emergency Medicine, Orthogeriatrics and Orthopaedic Specialities and Project management. INTERVENTIONS: LSS methodology was used to redesign an existing pathway, improving patient access to ortho-geriatrician assessment, pain relief and surgery in line with the Irish Hip Fracture Data Base Key performance indicators. MAIN OUTCOME MEASURES: Access to pain relief, access to surgery and volume of patients receiving ortho-geriatric assessment. RESULTS: The percentage of patients undergoing surgery within 48 h of presentation to Emergency Department increased from 55% to 79% at 3 months, and to 85% at 6 months. Improvements were also achieved in the secondary performance metrics relevant to quality of patient care. All care pathway changes were cost neutral. CONCLUSIONS: Hip fracture surgery within 48 h of presentation to hospital is a recognized standard of hip fracture care associated with decreased length of stay and decreased mortality. With respect to this performance metric, this intervention has contributed to improved patient outcomes.

Food and Nutrition Care in Long-Term Care Facilities: Examining the Perspectives of Frontline Workers.

Malnutrition in older adults residing in long-term care facilities continues to be a problem in the United States. Existing research has identified a list of possible contributing factors, including staffing problems. Few studies on food and nutrition care have attempted to gain the perspectives of nursing or dietary aides (henceforth, aides), the frontline staff who work most closely with the residents of long-term care facilities. The current study takes a qualitative approach grounded in a theoretical perspective based on Total Quality Management (TQM) to increase understanding of the interpersonal and management practices that affect resident wellbeing, health, and nutrition. Four focus groups (n = 24) were conducted with aides working in long-term care facilities. Aides expressed emotional closeness with residents and provided detailed knowledge about food and nutrition care. They reported both compassion fatigue and satisfaction. An element of dissatisfaction related to aide relationships with management and other employees who did not actively solicit their perspectives and knowledge on resident feeding. The knowledge and experience of aides could be better utilized by shifting management strategies to focus on employee empowerment and training. Principles of TQM could be applied to improve food and nutrition care in long-term care facilities.

The role of patient-centered care in nursing.

Patient-centered care (PCC) has become a key focus in the delivery of health care. It is necessary to gain some perspective of its fit into nursing, which has become physically and mentally demanding in the care of diverse populations. Although there is no agreed-upon definition or classification, there are several key aspects that work with PCC that are discussed in detail. This article provides more clarity to the role of nursing using several aspects of PCC in its many forms to improve the quality of care provided in a way that is both manageable and safe.

Determining the causal relationships among balanced scorecard perspectives on school safety performance: case of Saudi Arabia.

In the public schools of many developing countries, numerous accidents and incidents occur because of poor safety regulations and management systems. To improve the educational environment in Saudi Arabia, the Ministry of Education seeks novel approaches to measure school safety performance in order to decrease incidents and accidents. The main objective of this research was to develop a systematic approach for measuring Saudi school safety performance using the balanced scorecard framework philosophy. The evolved third generation balanced scorecard framework is considered to be a suitable and robust framework that captures the system-wide leading and lagging indicators of business performance. The balanced scorecard architecture is ideal for adaptation to complex areas such as safety management where a holistic system evaluation is more effective than traditional compartmentalised approaches. In developing the safety performance balanced scorecard for Saudi schools, the conceptual framework was first developed and peer-reviewed by eighteen Saudi education experts. Next, 200 participants, including teachers, school executives, and Ministry of Education officers, were recruited to rate both the importance and the performance of 79 measurement items used in the framework. Exploratory factor analysis, followed by the confirmatory partial least squares method, was then conducted in order to operationalise the safety performance balanced scorecard, which encapsulates the following five salient perspectives: safety management and leadership; safety learning and training; safety policy, procedures and processes; workforce safety culture; and safety performance. Partial least squares based structural equation modelling was then conducted to reveal five significant relationships between perspectives, namely, safety management and leadership had a significant effect on safety learning and training and safety policy, procedures and processes, both safety learning and training and safety policy, procedures and processes had significant effects on workforce safety culture, and workforce safety culture had a significant effect on safety performance.

[Development of Chinese herbal pieces and analysis of problems of total quality management].

Chinese herbal pieces are a key factor to protecting the quality of the clinical efficacy of traditional Chinese medicine (TCM), and it is one of the basic elements of ensuring the quality of TCM and people's usage safety. However, Chinese herbal pieces has massive problem such as adulteration and counterfeit, dyeing and weighting, pesticide residues, heavy metals in excess of the standards, and all the issues are repeated excessive in the clinic treatment. These issues impacted sound development of production, management and use of TCM, but also brings common people hidden trouble for the clinical safety of medication. Protect and improve the quality of the Chinese herbal pieces demand that continue improve quality system, in-depth scientific research, and strengthen self-discipline and other factors. So it is fundamentally to ensure good quality of Chinese herbal pieces with the color, taste and shape by systematic supervision to it from the source, production, management and research, with strengthened implementation and en- forcement of the "3G".

Quality planning, part 1: a holistic and practical approach.

This article is the first in a two-part series that breaks down quality planning into a systematic, stepwise process. Part 1 addresses the tangible aspects of compounding that directly influence the quality of compounded preparations. Part 2 will speak to less tangible but critically important mechanisms targeting continuous improvement. The author takes a holistic approach, which he describes as a comprehensive, systematic, and proactive approach to continuously improve everything that may, directly or indirectly, influence the quality of a preparation or service.

Creating an effort tracking tool to improve therapeutic cancer clinical trials workload management and budgeting.

Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.

Implementing continuous quality improvement process in potassium management in peritoneal dialysis patients.

BACKGROUND: Abnormal plasma potassium levels are not uncommon in peritoneal dialysis (PD) patients. Here, we implemented a continuous quality improvement (CQI) approach that mainly focused on dietary management to improve potassium control in PD patients. METHODS: All clinically stable patients who visited the PD clinic monthly were included in this study. A CQI team that included nephrologists, primary nurses, dietician, patients, and their family members was organized, and it monitored patients for 6 months. Patients were asked to provide their dialysis records and 3-day dietary records at each visit. Dialysis adequacy, including potassium and phosphorus removals, was checked before and after the implementation of CQI. Changes in dietary prescription, without altering dialysis prescriptions and potassium supplementation, were made monthly, according to patients' dietary information and blood potassium levels. RESULTS: In total, 84 patients (28 male and 56 female) were included in this study. At baseline, the prevalence of hyperkalemia and hypokalemia was 14.3% each. After the intervention, the prevalence of hyperkalemia dropped to 10.7% and 6% at 3 months and 6 months, respectively. The prevalence of hypokalemia dropped to 8.3% and 7.1% at 3 months and 6 months, respectively. CONCLUSIONS: Our data suggest that implementing CQI, with a focus on dietary intervention, could significantly reduce the prevalence of potassium abnormality in PD patients.

Building capacity for a transformation initiative: system redesign at Denver Health.

BACKGROUND: This article examines the development of transformation initiatives-deliberate attempts to achieve systemic changes and rapid performance improvements. Accounts of transformation initiatives often reveal little about past organizational and contextual conditions that contributed to success. Instead, these accounts concentrate on change barriers. PURPOSE: We seek to restore balance to this field by examining how antecedent system capacities contributed to a successful transformation initiative. METHODOLOGY: This article presents a case study of the first 2 years of a system redesign initiative at an integrated safety-net health system and provides a historical analysis of developments during the decade preceding the redesign. FINDINGS: Beginning in the mid-1990 s, Denver Health benefited from strong municipal support for its development and expansion. Gradually, it developed its financial and human resources, organizational structure, change strategy, change-management capabilities, information technology, and physical plant. These antecedent capacities all contributed to the implementation of the 2004 system redesign and helped Denver Health overcome several constraints. IMPLICATIONS: Transformation initiatives may build on existing features and resources, even as they overcome or depart from others. The Denver Health case study helps researchers identify positive antecedents to transformation initiatives, assess the success of such initiatives in terms of implementation progress and outcomes, and recognize complementary contributions of incremental and episodic changes. The study alerts practitioners to the importance of assuring that change efforts rest on solid organizational foundations.

Hospital innovativeness and organizational performance: evidence from English public acute care.

BACKGROUND: Hospitals around the world dedicate increasing attention and resources to innovation. However, surprisingly little is known about the nature of hospital innovativeness and its relationship with organizational performance. Given both the specific characteristics of the hospital sector and the rather mixed evidence from other industries, a positive innovation-performance link should not be taken for granted but requires empirical examination. PURPOSES: The purposes of this study were to introduce a perspective of hospitals as vital generators of innovation, to unpack the concept of innovativeness, to propose a measurement model for hospital innovativeness, and to empirically investigate the innovativeness-performance relationship. METHODOLOGY: We conducted a large-scale empirical study among the entire population of public hospital organizations that are part of the English National Health Service (n = 173) and analyzed the data using exploratory factor and regression analyses. FINDINGS: Our analyses suggest a significant positive relationship between science- and practice-based innovativeness and clinical performance but provide less unambiguous support for the existence of such a relationship between innovativeness and administrative performance. In particular, we find that higher levels of innovativeness are rather associated with superior quality of care than with measurable bottom-line financial benefits. PRACTICE IMPLICATIONS: Hospitals investing in innovation-generating activities might find their efforts well rewarded in terms of tangible clinical performance improvements. However, to achieve measurable financial benefits, numerous hospitals have yet to discover and capture the commercial value of some of their innovations-a challenging task that requires a holistic innovation management and an effective network of complementary partners.

Development, testing, and national evaluation of a pediatric Patient-Family-Centered Care benchmarking survey.

This study provides evidence for reliability (the Cronbach alpha of .76-.94) and construct validity of the Patient-Family-Centered Care Survey developed by the researchers in collaboration with FKP Architects, used to measure and benchmark practice within pediatric institutions. The survey evaluates progress of integrating patient-family-centered care over time and can be triangulated with measurements of desired patient and institutional outcomes.

[Introduction to the consolidated criteria for reporting qualitative research].

Qualitative research methods are becoming more and more important in medical research area. Some qualitative researches played important roles in the exploration and the spread of core ideas of Chinese medicine. The report of qualitative research should be transparent and credible according to the standardized report criterion. On the basis of 22 criteria, the Consolidated Criteria for Reporting Qualitative Research (COREQ) was developed and published in September 2007. This introduction to COREQ will be helpful to Chinese qualitative researchers and readers in the implementation of high quality of medical qualitative research in China.

Enhancing patient engagement in chronic disease self-management support initiatives in Australia: the need for an integrated approach.

Although emphasis on the prevention of chronic disease is important, governments in Australia need to balance this with continued assistance to the 77% of Australians reported to have at least one long-term medical condition. Self-management support is provided by health care and community services to enhance patients' ability to care for their chronic conditions in a cooperative framework. In Australia, there is a range of self-management support initiatives that have targeted patients (most notably, chronic disease self-management education programs) and health professionals (financial incentives, education and training). To date, there has been little coordination or integration of these self-management initiatives to enhance the patient-health professional clinical encounter. If self-management support is to work, there is a need to better understand the infrastructure, systems and training that are required to engage the key stakeholders - patients, carers, health professionals, and health care organisations. A coordinated approach is required in implementing these elements within existing and new health service models to enhance uptake and sustainability.

Premier launches new hospital QI collaborative.

Measurements will include mortality, appropriate care, efficiency, harm avoidance, patient satisfaction. Improving health of communities is one of program's primary aims. Goal is to move 50% of participants into the top quartiles for all measures.

Acceptance of PACS utilizing a PACS QI Program.

This article describes the quality improvement program that Mercy Hospital (Alegent Health System) initiated after it implemented a picture archiving and communication system (PACS) in November 2003. The radiology department encountered numerous PACS-related issues that directly affected the quality and workflow of patient care. In order to get a better understanding of the situation, the department developed a quality improvement plan for its PACS program. The first step was to dedicate a resource--in this case, a radiology information technology (RIT) support specialist--who would serve as a PACS subject matter expert while dealing with day-to-day PACS-related issues--specifically, errors. The error data were collected and categorized for consistency using statistical process control (SPC) tools. The information gathered was then traced back to the team members responsible for the errors and used as a training tool to further educate them. As a result of this program, the average error rate was reduced from 12% to 4% because the radiology team developed a better understanding of the errors by identifying the root causes and being accountable for eliminating errors within their control. In addition, the radiology staff learned to accept and trust the PACS, resulting in a positive culture change that benefited teamwork and staff morale as well as improve the workflow and the quality of patient care.