Formal Quality System Research Articles

Healthcare professionals' experience with nutritional care beyond formal quality systems — A qualitative study

BackgroundNumerous formal strategies, screening tools, and interventions have been used to prevent malnutrition in long-term care patients. Despite these efforts, the proportion of screened patients is low, and a large proportion are malnourished. Previous research has revealed that healthcare professionals use a broad approach in their nutritional care but has also emphasised the need for further investigation into these approaches. ObjectiveTo explore how healthcare professionals working in long-term care experience and apply nutritional care. DesignA descriptive, exploratory, qualitative design containing 240 h of participant observation, 12 focus groups and 2 individual interviews. Setting(s)Twelve nursing homes and home care units in three Norwegian municipalities. ParticipantsParticipant observation of interactions between healthcare professionals and patients. Forty-three registered nurses participated in focus group or individual interviews. MethodsThe data were analysed using inductive thematic analysis. ResultsThe analysis identified three themes: The first theme, limited significance of nutritional screening, showed that healthcare professionals experienced the limited value of nutritional screening, as it often did not capture patients' nutritional challenges. They also perceived nutritional screening as unsuitable for patients at the end of their lives, those with overweight-related complications, or undergoing rehabilitation. In addition, nutritional screening was perceived as something healthcare professionals did for their managers or administrators, not because it was crucial to providing good nutritional care. The second theme, provision of individualised food, captures the healthcare professionals' efforts in adapting and preparing food according to the patient's preferences. Facilitation to enable patients to make individual food choices and the use of food cards or lists were two approaches to individualising nutrition care. The third theme, making meals more than about food, elucidated how healthcare professionals used meals to help patients cope with their situations and experience social belonging. Conversations about or around meals were used to provide patients with a sense of belonging to their past or present situation. The meals were also used as a diversion strategy for patients with unrest, as arenas for daily activity training, and for meaningful social interactions between patients around the tables. ConclusionsNutritional screening and prevention of malnutrition are only one part of healthcare professionals' nutritional care. Individualised food and meals that create coping, a sense of belonging, and social experiences are equally important parts of their care. Emphasising healthcare professional's person-centred approach to nutritional care would be beneficial, as it could strengthen and further develop long-term nutritional care services.

Human-derived raw materials: Controlled, consistent collections enable successful manufacturing of cell-based regenerative medicine products (TECH1P.847)

Abstract Human cells are critical raw materials for manufacturing cell therapy products, but introduce significant variability. HemaCare controls apheresis procedures and collection sites under a formal quality system, with GMP-compliant, validated procedures and equipment, and GTP-compliant donor screening and tracking. HemaCare performed 86,799 cellular apheresis collections in the last 7 years for research, clinical trials, and commercial products. HemaCare’s unmobilized apheresis products showed consistently high MNC purity, with 93.8% of products containing ≥75% MNC, and an average of 85.66% MNC±7.1% (mean±1 SD). RBC contamination was low, with hematocrit averaging 1.78%±0.7%. Approximately 85% of HemaCare donors have donated apheresis products 5 or more times. HemaCare’s laboratory is equipped with Miltenyi Biotec technology for isolation of raw material into purified cellular subpopulations. The consistency and viability of the purified end products are measured with flow cytometry. Using BioLife Solutions’ serum-free and protein-free cGMP CryoStor™ cryopreservation media with purified cells, post-thaw recovery rates of cell fractions have been above 95%; dendritic cell and macrophage have demonstrated recovery rates of ≥90%. CryoStor™, in combination with freezing in the BioCision CoolCell™ freezing container, has enabled HemaCare to standardize the cryopreservation process, reducing variability while optimizing post-thaw viable cell recovery of its research products.

Human blood-derived raw material: enabling controlled, consistent collection (P4415)

Abstract Human cells are critical raw materials for manufacturing cell therapy products, but often introduce significant variability. Rigorous operational controls and quality systems, however, enable optimal collection of high-quality, consistent cellular material. HemaCare, a long-standing supplier of human-derived blood components, controls apheresis procedures and collection sites under a formal quality system, with GMP-compliant, validated procedures and equipment, and GTP-compliant donor screening and tracking. HemaCare performed 69,658 cellular apheresis collections in the last five years, including patient and normal-donor MNCs, G-CSF-mobilized PBPCs and plateletpheresis products, for use in research, clinical trials, and commercial products. Expanded capabilities include bone marrow, umbilical cord blood, and cord tissue collection, immunomagnetic selection, cryopreservation, and analysis by flow cytometry. HemaCare unmobilized apheresis products showed consistently high MNC purity, with 93.8% of products containing ≥75% MNC, and an average of 85.2% MNC ± 6.6% (mean ± 1 SD). Red blood cell contamination was low, with hematocrit averaging 1.8% ± 0.8%. Approximately 85% of HemaCare donors have donated apheresis products 5 or more times, and this repeat-donor pool also contributes to product consistency, as MNC content of individual donor apheresis products had an average coefficient of variation of 3.5%, compared to a CV of 7.7% for all apheresis products.

Thoughts on quality systems

An intrinsic, universal definition of quality has been quite elusive. As applied to products and services, the impressions of users are so subjective as to escape definition. To some extent producers see it in terms of what people will continue to buy, and if they will buy large amounts, the quality must be exceptionally good. While an absolute scale may escape us, changes along the scale do not. If a product (say coffee) or a service (say a haircut) changes by even a small amount we tend to notice and judge it as being higher or lower in quality. Quality systems, for example ISO 9000, and ISO 17025, can be used to facilitate products and services that are acceptable to clients by avoiding decreases in perceived quality. More about this in a moment. There is a physical approach to defining quality that is based on matching or exceeding defined physical requirements. This is an arena where formal quality systems have great utility. The client can test to see if his requirements are indeed met. Yet, even here the definition of quality may elude us. When the components are assembled into products, they will be judged by the customers based on intangibles that go beyond individual components exceeding requirements. Overall design, color, feel, and user friendliness will have a role in the customers’ judgment of quality. Even that judgment is likely to be relative to other products (or the ‘‘last one I owned’’) without any quantitative figure of merit on an absolute scale. Taking all of this into account, we see that there is not yet an acceptable scale for measurement of quality. Lacking that scale, we cannot quantify even small changes up or down from a fixed point. However, we usually can judge if a different product or service is better or worse than the previous one with respect to whatever attributes of quality we choose. This restricts any attempt at formal quantification. The way quality systems serve to assure meeting defined physical requirements is essentially the same as for meeting customer perceptions: that is to reduce variability to an acceptable or specified minimum. Reducing variability (improving the precision of the process) is critical before the process can be ‘‘tweaked’’ to improve quality. Without a stable system there can be no meaningful adjustments. A given adjustment in an unstable system may provide an instantaneous improvement in perceived quality, but there can be no assurance that the improvement will be reproducible. Thus we see quality systems are of utility in applications where rigidity and invariance are required to maintain acceptably low variation in output. Overall, this situation is found in chemical laboratories only where there is an ongoing pattern of analyzing very similar items. Examples could include clinical, steelmaking, sports doping, and soil testing labs. The emphasis in all these is routine, with sufficient repetition to assess variability and adequately control it through exercise of rigid procedures such as those developed to comply with ISO 17025. Quality systems are likely to be less helpful in chemical laboratories where analyses are not routine. That could include academic, high-level metrology, investigative, and consulting labs where very diverse materials are analyzed. This observation may help us to answer a question raised by such studies as IMEP. (Details on all Interlaboratory Comparisons of IMEP are available at: http://irmm.jrc.ec. europa.eu/html/interlaboratory_comparisons/imep/index. htm). Expert analytical chemists recognize IMEP for its S. D. Rasberry (&) 1255 Glebe Road, Lottsburg, VA 22511, USA e-mail: rasberry@rivnet.net

Toolkits for nuclear science: Data and spreadsheets

In the past decade, the combination of readily accessible, reliable data in electronic form with well-tested spreadsheet programs has changed the approach to experiment planning and computation of results. This has led to a flowering of software applications based on spreadsheets, mostly written by scientists, not by professional programmers trained in numerical methods. Formal quality systems increasingly call for verified computational methods and reference data as part of the analytical process, a demand that is difficult to meet with most spreadsheets. Examples are given of utilities used in our laboratory, with suggestions for verification and quality maintenance.

The new ISO 9001 and the problem of ceremonial conformity: How have audit methods evolved?

The new edition of the ISO 9001 standard increases the overlap between the elements that characterize certified quality systems and the logic of Total Quality Management. Parallel to the conceptual evolution of the norm there must be an evolution towards the so-called performance/management audit model, in order to increase the ability to unveil ceremonial conformity and thus increase the value of the certifications. The evolution of the logic of audits takes on particular importance in the context of small and medium sized enterprises (SMEs) since these companies tend to implement formal quality systems only when there is significant external pressure to do so, and when they do, their approach to the implementation of the ISO 9001 standard tends to be minimalist. In this article, the development of a tool for assessing conformity audits (made up of a set of ‘behavioural indicators’ which describe the actions that represent a behaviour that adheres to the logic of performance audit) is described and the results of an empirical study of a sample of 114 SMEs in the Veneto region are presented. The study highlights the uncertain nature of the evolution of conformity assessments and the prevalence of behaviours related to traditional audits in the indicators that best reflect the innovative logic of performance audits. This is an important message for the national accreditation bodies (at present, in Italy, SINCERT) which qualify auditors and try to make the certification system credible.

Quality systems implementation in Welsh small- to medium-sized enterprises: A global comparison and a model for change

This paper initially investigates the rate of development and subsequent implementation of structured quality management systems (e.g. ISO 9000, EFQM, etc.) within small- to medium-sized enterprises (SMEs) in South Wales. While the effective implementation of quality systems in SMEs is seen as a major priority to the supply chain and quality professionals alike [1], the implementation of formal quality systems within SMEs in South Wales is still very low. The common reasons of high cost, high effort and limited effectiveness are given by SMEs for the poor implementation rate, but a wider set of arguments that go beyond these issues are presented. This naturally raises the question as to whether it is at all possible to implement such formal systems within SMEs, or whether there is a need to develop an effective model specifically for small-to-medium manufacturing enterprises. The findings from a survey of some 500 manufacturing-based SMEs in South Wales are used alongside comparative studies conducted by academics in the United States, Sweden, Australia and New Zealand into SME activities in order to provide a broader explanation for the poor implementation level of quality management systems. The paper then goes on to developing a conceptual framework for the development of a specific SME quality model.

ISO compliant laboratory quality systems and incident monitoring improve the implementation of laboratory information systems

Quality systems can provide a means of measuring the rate of occurrence of defined incidents and non-conformities. We have studied the application of laboratory quality systems to monitoring the implementation of laboratory information systems (LIS) in two similar size tertiary hospital pathology laboratories in Australia. At one site, one department implemented a quality system accredited to ISO 9001–1987 and ISO 9001–1994 while the rest of the organisation did not have a formal quality system; this site implemented the Cerner PathNet LIS. At the other site, the organisation was in the process of implementing ISO/IEC Guide 25–1990 and ISO/IEC 17025–1999; this site implemented the PJACC AUSLAB LIS. The rate of quality system incidents and non-conformities was used to track the progress of implementation of the LIS. We found that different quality systems appeared equally useful in monitoring the rate of occurrence of incidents. However, the presence of a formal quality system greatly improved the proportion of incidents that could be investigated and resolved at root cause level. Incident monitoring, as part of a formal quality system, proved to be a useful tool in monitoring and managing the implementation of these LIS.

Medical audit: threat or opportunity for the medical profession. A comparative study of medical audit among medical specialists in general hospitals in the Netherlands and England, 1970–1999

Medical audit has been introduced among hospital specialists in both the Netherlands and England. In the Netherlands following some local experiments, medical audit was promoted nationally as early as 1976 by the medical profession itself and became a mandatory activity under the Hospital Licensing Act of 1984. In England it was the government who promoted medical audit as a compulsory activity for medical specialists, in particular since 1989. In this article the development and introduction of medical audit in the two health care systems is described and its impact on the clinical autonomy of medical specialists gauged . It is concluded that in both countries external pressures seem to have been crucial in the ‘compulsory’ introduction of medical audit. Although there are differences in the organisation and culture of the medical profession in the two countries, in both countries medical audit turned out to be an instrument ‘controlled’ by the profession itself. The question whether medical audit is instrumental in preserving clinical autonomy has also been addressed. Our conclusion is that in its present form medical audit in the two countries has not been a threat to the clinical autonomy of the medical profession. At the same time it is clear that the study of one quality instrument is insufficient to draw conclusions about the development of clinical autonomy, let alone autonomy in general. Moreover, it remains to be seen how medical audit can survive alongside quality improvement mechanisms such as accreditation, certification, performance indicators and formal quality systems (ISO, EFQM) where hospital management executes more control. The history of medical audit in the Netherlands and England over the past 30 years does illustrate, however, the capability of the profession to maintain autonomy through re-negotiated mechanisms for self-control.

Preparing an enterprise for ISO 9000 certification

Identifies the basic components of a formal quality system. Uses research into 100 companies to assess how well they address each of these components and creates a resulting typology of companies, according to the way in which they organise their quality systems. This simple analysis can be used as a basic model by an enterprise which wishes to implement a process leading to formal quality certification such as ISO 9000.

Achieving exemplary quality in the construction professions

Explores the nature of quality management in professional practices regarded as exemplary by experienced clients. Ten case studies of projects carried out by such firms were selected. Focuses on three areas: the view of professional clients; the approach to quality management taken by exemplary practices; and the approach taken to managing change taken by these practices. Reaches four main conclusions: quality culture was regarded by both clients and practitioners as more important than a formal quality system; clients tended to devote more effort to initial selection of professionals than to subsequently monitoring their performance; exemplary professionals were guided by their own strong principles rather than simply reacting to client instructions; briefing was a key element in project success.

Preparing an enterprise for ISO 9000 certification

Identifies the basic components of a formal quality system. Uses research into 100 companies to assess how well they address each of these components and creates a resulting typology of companies, according to the way in which they organise their quality systems. This simple analysis can be used as a basic model by an enterprise which wishes to implement a process leading to formal quality certification such as ISO 9000.

Quality assurance good practice for research and development and non-routine analysis

The application of quality assurance to routine analytical testing is fairly well established with widespread availability of general and specific guidance, both on general principles and in support of quality standards and accreditation/certification schemes. The application to non-routine work is less straightforward and widely available guidance has only recently become available with the development and publication of the EURACHEM/CITAC Guide `Quality Assurance Good Practice for Research and Development and Non-routine Analysis'. A workshop on the guide, and the issues which it aims to address was held during the EUROANALYSIS 10 Conference, Basel, Switzerland, 6-11 September 1998. This paper presents a summary of the presentations and discussions from that workshop. In addition to introducing the guide the workshop examined the possibilities of formal quality systems for research and development, aspects of quality assurance in the academic world, and various technical elements of quality assurance. The paper concludes with findings from group discussions on these topics.

Introducing a formal quality system in a medical department: case study of the ENT (ORL) Department at the Catholic University Leuven

This paper describes the experience of introducing a formal Quality System in the ENT (Ear - Nose - Throat - Head & Neck surgery) department of the Medical Faculty at K.U.Leuven. This department is a typical medical unit in a university environment with responsibilities for education, research and patient service. Today, formal Quality Systems are well introduced in production organisations and they also emerge in service organisations, but they are much less common in university medical departments. Quality systems are used as a tool for quality assurance and continuous improvement. This paper describes the different phases in the development of the ENT-quality system. After describing the origin and history of the project, we elaborate on the structure of the formal Quality System (based upon a quality handbook, procedures, measurement of performance indicators, corrective and preventive actions). Finally, we comment on implementation issues and plans for future development.

SERVQUAL and the Northern Ireland hotel sector: a comparative analysis ‐ part 2

Some practitioners maintain that the main problem with introducing a quality management system such as ISO 9000, is the amount of paperwork required to maintain it. Many believe it is purely a bureaucratic paperwork exercise and managers are so busy chasing paper that they do not find time to concentrate on genuine quality and business improvement. This was recognized by managers of the Cowie Group plc, the major UK motor finance and specialist distribution, and bus operator, when introducing their formal quality system. Outlines a collaborative project with the University of Sunderland Business School, which assesses the feasibility of developing semi‐intelligent computer software which manages parts of the quality system and enables managers to concentrate on quality improvement of the overall business, and its various processes. It begins by discussing how the Cowie Group introduced a quality system to their operations and how this effected their activities. The next section discusses the practical, technical and cultural problems experienced when implementing this model, and how the group decided to resolve these using current computer technology. Concludes by highlighting problems associated with this and sets the ground rules for resolving these as part of the “semi‐intelligent quality system”.

In praise of ISO 9000

Describes the relationship between formal quality standards and total quality, supporting the necessity for a formal quality system for most businesses. Addresses the common criticisms of ISO 9000, sets out the minimum criteria for its implementation and a long list of user‐reported benefits.

Achieving quality and productivity in the house building sector

Reports on the results of a research study which sought to investigate the impact of quality management systems (QMS) based on BS5750 on construction productivity of UK building contractors specializing in the housing sector. The main variables of the study (quality and productivity) have been operationalized as follows: quality, the companies were classified as having a formal quality system if they were registered to BS5750; productivity of a construction project was defined and measured in terms of the utilization of resources used by the contractors in every project. Owing to the heterogeneity of construction output in general, it was necessary to use the monetary value of resources in an effort to standardize output and apply a certain measure of harmony to it; such that useful comparison may be made. Data were drawn from priced bills of quantities and the productivity of QMS and non‐QMS contractors was modelled through utilization of the theory of isoquants. Results pointed towards the acceptance of the hypothesis that there is a relationship between the implementation of QMS and productivity on site.