Managing healthcare technology in quality management framework

Healthcare services available these days deploy high technology to satisfy both internal and external customers by continuously improving various quality parameters. Quality improvement in healthcare services is a complex and multidimensional task. Although various quality management tools are routinely deployed for identifying quality issues in healthcare delivery, there is absence of an integrated approach, which can identify and analyse issues, provide solutions to resolve those issues and develop a project management framework to implement and evaluate those solutions. This study introduces an integrated and uniform quality management framework for healthcare services. This study uses the Logical Framework Analysis (LFA) to improve the performance of healthcare services. LFA has three major steps - problem identification, solution derivation and formation of a planning matrix for implementation and evaluation. LFA has been applied in a case study environment to three acute healthcare services (Operating Room (OR) utilisation, Accident and Emergency (A&E) and intensive care) in order to demonstrate its effectiveness. Copyright © 2007 Inderscience Enterprises Ltd.

Quality control of pharmaceutical ingredients:developing a caking test for industry

Objectives - Powdered and granulated particulate materials make up most of the ingredients of pharmaceuticals and are often at risk of undergoing unwanted agglomeration, or caking, during transport or storage. This is particularly acute when bulk powders are exposed to extreme swings in temperature and relative humidity, which is now common as drugs are produced and administered in increasingly hostile climates and are stored for longer periods of time prior to use. This study explores the possibility of using a uniaxial unconfined compression test to compare the strength of caked agglomerates exposed to different temperatures and relative humidities. This is part of a longer-term study to construct a protocol to predict the caking tendency of a new bulk material from individual particle properties. The main challenge is to develop techniques that provide repeatable results yet are presented simply enough to be useful to a wide range of industries. Methods - Powdered sucrose, a major pharmaceutical ingredient, was poured into a split die and exposed to high and low relative humidity cycles at room temperature. The typical ranges were 20–30% for the lower value and 70–80% for the higher value. The outer die casing was then removed and the resultant agglomerate was subjected to an unconfined compression test using a plunger fitted to a Zwick compression tester. The force against displacement was logged so that the dynamics of failure as well as the failure load of the sample could be recorded. The experimental matrix included varying the number of cycles, the amount between the maximum and minimum relative humidity, the height and diameters of the samples, the number of cycles and the particle size. Results - Trends showed that the tensile strength of the agglomerates increased with the number of cycles and also with the more extreme swings in relative humidity. This agrees with previous work on alternative methods of measuring the tensile strength of sugar agglomerates formed from humidity cycling (Leaper et al 2003). Conclusions - The results show that at the very least the uniaxial tester is a good comparative tester to examine the caking tendency of powdered materials, with a simple arrangement and operation that are compatible with the requirements of industry. However, further work is required to continue to optimize the height/ diameter ratio during tests.

Application of excitation emission matrix fluorescence monitoring in the assessment of spatial and seasonal drivers of dissolved organic matter composition: Sources and physical disturbance controls

The environmental dynamics of dissolved organic matter (DOM) were characterized for a shallow, subtropical, seagrass-dominated estuarine bay, namely Florida Bay, USA. Large spatial and seasonal variations in DOM quantity and quality were assessed using dissolved organic C (DOC) measurements and spectrophotometric properties including excitation emission matrix (EEM) fluorescence with parallel factor analysis (PARAFAC). Surface water samples were collected monthly for 2 years across the bay. DOM characteristics were statistically different across the bay, and the bay was spatially characterized into four basins based on chemical characteristics of DOM as determined by EEM-PARAFAC. Differences between zones were explained based on hydrology, geomorphology, and primary productivity of the local seagrass community. In addition, potential disturbance effects from a very active hurricane season were identified. Although the overall seasonal patterns of DOM variations were not significantly affected on a bay-wide scale by this disturbance, enhanced freshwater delivery and associated P and DOM inputs (both quantity and quality) were suggested as potential drivers for the appearance of algal blooms in high impact areas. The application of EEM-PARAFAC proved to be ideally suited for studies requiring high sample throughput methods to assess spatial and temporal ecological drivers and to determine disturbance-induced impacts in aquatic ecosystems.

The Effect of Sample and Sample Matrix on DNA Processing: Mechanisms for the Detection and Management of Inhibition in Forensic Samples

The presence of inhibitory substances in biological forensic samples has, and continues to affect the quality of the data generated following DNA typing processes. Although the chemistries used during the procedures have been enhanced to mitigate the effects of these deleterious compounds, some challenges remain. Inhibitors can be components of the samples, the substrate where samples were deposited or chemical(s) associated to the DNA purification step. Therefore, a thorough understanding of the extraction processes and their ability to handle the various types of inhibitory substances can help define the best analytical processing for any given sample. A series of experiments were conducted to establish the inhibition tolerance of quantification and amplification kits using common inhibitory substances in order to determine if current laboratory practices are optimal for identifying potential problems associated with inhibition. DART mass spectrometry was used to determine the amount of inhibitor carryover after sample purification, its correlation to the initial inhibitor input in the sample and the overall effect in the results. Finally, a novel alternative at gathering investigative leads from samples that would otherwise be ineffective for DNA typing due to the large amounts of inhibitory substances and/or environmental degradation was tested. This included generating data associated with microbial peak signatures to identify locations of clandestine human graves. Results demonstrate that the current methods for assessing inhibition are not necessarily accurate, as samples that appear inhibited in the quantification process can yield full DNA profiles, while those that do not indicate inhibition may suffer from lowered amplification efficiency or PCR artifacts. The extraction methods tested were able to remove >90% of the inhibitors from all samples with the exception of phenol, which was present in variable amounts whenever the organic extraction approach was utilized. Although the results attained suggested that most inhibitors produce minimal effect on downstream applications, analysts should practice caution when selecting the best extraction method for particular samples, as casework DNA samples are often present in small quantities and can contain an overwhelming amount of inhibitory substances.

Measurement resource planning:a methodology that uses quality characteristics mapping

Integration of the measurement activity into the production process is an essential rule in digital enterprise technology, especially for large volume product manufacturing, such as aerospace, shipbuilding, power generation and automotive industries. Measurement resource planning is a structured method of selecting and deploying necessary measurement resources to implement quality aims of product development. In this research, a new mapping approach for measurement resource planning is proposed. Firstly, quality aims are identified in the form of a number of specifications and engineering requirements of one quality characteristics (QCs) at a specific stage of product life cycle, and also measurement systems are classified according to the attribute of QCs. Secondly, a matrix mapping approach for measurement resource planning is outlined together with an optimization algorithm for combination between quality aims and measurement systems. Finally, the proposed methodology has been studied in shipbuilding to solve the problem of measurement resource planning, by which the measurement resources are deployed to satisfy all the quality aims. © Springer-Verlag Berlin Heidelberg 2010.

Development of an instrument measuring the quality of residential care facilities for older people

Aims. To validate the Swedish version of the Sheffield Care Environment Assessment Matrix (S-SCEAM). The instrument’s items measure environmental elements important for supporting the needs of older people, and conceptualized within eight domains. Methods. Item relevance was assessed by a group of experts and measured using content validity index (CVI). Test-retest and inter-rater reliability tests were performed.  The domain structure was assessed by the inter-rater agreement of a second group of experts, and measured using Fleiss kappa. Results. All items attained a CVI above 0.78, the suggested criteria for excellent content validity. Test-retest reliability showed high stability (96% and 95% for two independent raters respectively), and inter-rater reliability demonstrated high levels of agreement (95% and 94% on two separate rating occasions). Kappa values were very good for test-retest (κ = 0.903 and 0.869) and inter-rater reliability (κ = 0.851 and 0.832). Domain structure was good,  Fleiss’ kappa was 0.63 (range 0.45 to 0.75).    Conclusion. The S-SCEAM of 210 items and eight domains showed good content validity and construct validity. The instrument is suggested for use in measuring of the quality of the physical environment in residential care facilities for older persons.

The Phosphate Source Influences Gene Expression and Quality of Mineralization during In Vitro Osteogenic Differentiation of Human Mesenchymal Stem Cells

For in vitro differentiation of bone marrow-derived mesenchymal stem cells/mesenchymal stromal cells into osteoblasts by 2-dimensional cell culture a variety of protocols have been used and evaluated in the past. Especially the external phosphate source used to induce mineralization varies considerably both in respect to chemical composition and concentration. In light of the recent findings that inorganic phosphate directs gene expression of genes crucial for bone development, the need for a standardized phosphate source in in vitro differentiation becomes apparent. We show that chemical composition (inorganic versus organic phosphate origin) and concentration of phosphate supplementation exert a severe impact on the results of gene expression for the genes commonly used as markers for osteoblast formation as well as on the composition of the mineral formed. Specifically, the intensity of gene expression does not necessarily correlate with a high quality mineralized matrix. Our study demonstrates advantages of using inorganic phosphate instead of beta-glycerophosphate and propose colorimetric quantification methods for calcium and phosphate ions as cost-and time-effective alternatives to X-ray diffraction and Fourier-transform infrared spectroscopy for determination of the calcium phosphate ratio and concentration of mineral matrix formed under in vitro-conditions. We critically discuss the different assays used to assess in vitro bone formation in respect to specificity and provide a detailed in vitro protocol that could help to avoid contradictory results due to variances in experimental design.

Stable Incretin Mimetics Counter Rapid Deterioration of Bone Quality in Type 1 Diabetes Mellitus.

International audience

Determination of thresholds in marine molluscs as an alternative to the Environmental Quality Standards in marine water defined in the Water Framework Directive

The Water Framework Directive (WFD) establishes Environmental Quality Standards (EQS) in marine water for 34 priority substances. Among these substances, 25 are hydrophobic and bioaccumulable (2 metals and 23 organic compounds). For these 25 substances, monitoring in water matrix is not appropriate and an alternative matrix should be developed. Bivalve mollusks, particularly mussels (Mytilus edulis, Mytilus galloprovincialis), are used by Ifremer as a quantitative biological indicator since 1979 in France, to assess the marine water quality. This study has been carried out in order to determine thresholds in mussels at least as protective as EQS in marine water laid down by the WFD. Three steps are defined: - Provide an overview of knowledges about the relations between the concentrations of contaminants in the marine water and mussels through bioaccumulation factor (BAF) and bioconcentration factor (BCF). This allows to examine how a BCF or a BAF can be determined: BCF can be determined experimentally (according to US EPA or ASTM standards), or by Quantitative Activity-Structure Relationship models (QSAR): four equations can be used for mussels. BAF can be determined by field experiment; but none standards exists. It could be determined by using QSAR but this method is considered as invalid for mussels, or by using existing model: Dynamic Budget Model, but this is complex to use. - Collect concentrations data in marine water (Cwater) in bibliography for those 25 substances; and compare them with concentration in mussels (Cmussels) obtained through French monitoring network of chemicals contaminants (ROCCH) and biological integrator network RINBIO. According to available data, this leads to determine the BAF or the BCF (Cmussels /Cwater) with field data. - Compare BAF and BCF values (when available) obtained with various methods for these substances: BCF (stemming from the bibliography, using experimental process), BCF calculated by QSAR and BAF determined using field data. This study points out that experimental BCF data are available for 3 substances (Chlorpyrifos, HCH, Pentachlorobenzene). BCF by QSAR can be calculated for 20 substances. The use of field data allows to evaluate 4 BAF for organic compounds and 2 BAF for metals. Using these BAF or BCF value, thresholds in shellfish can be determined as an alternative to EQS in marine water.

The effect of sample and sample matrix on DNA processing: Mechanisms for the detection and management of inhibition in forensic samples

The presence of inhibitory substances in biological forensic samples has, and continues to affect the quality of the data generated following DNA typing processes. Although the chemistries used during the procedures have been enhanced to mitigate the effects of these deleterious compounds, some challenges remain. Inhibitors can be components of the samples, the substrate where samples were deposited or chemical(s) associated to the DNA purification step. Therefore, a thorough understanding of the extraction processes and their ability to handle the various types of inhibitory substances can help define the best analytical processing for any given sample. A series of experiments were conducted to establish the inhibition tolerance of quantification and amplification kits using common inhibitory substances in order to determine if current laboratory practices are optimal for identifying potential problems associated with inhibition. DART mass spectrometry was used to determine the amount of inhibitor carryover after sample purification, its correlation to the initial inhibitor input in the sample and the overall effect in the results. Finally, a novel alternative at gathering investigative leads from samples that would otherwise be ineffective for DNA typing due to the large amounts of inhibitory substances and/or environmental degradation was tested. This included generating data associated with microbial peak signatures to identify locations of clandestine human graves. Results demonstrate that the current methods for assessing inhibition are not necessarily accurate, as samples that appear inhibited in the quantification process can yield full DNA profiles, while those that do not indicate inhibition may suffer from lowered amplification efficiency or PCR artifacts. The extraction methods tested were able to remove >90% of the inhibitors from all samples with the exception of phenol, which was present in variable amounts whenever the organic extraction approach was utilized. Although the results attained suggested that most inhibitors produce minimal effect on downstream applications, analysts should practice caution when selecting the best extraction method for particular samples, as casework DNA samples are often present in small quantities and can contain an overwhelming amount of inhibitory substances.^

The quality of the physical environment and its association with activities and well-being among older people in residential care facilities

The physical environment can influence older people’s health and well-being, and is often mentioned as being an important factor for person-centred care. Due to high levels of frail health, many older people spend a majority of their time within care facilities and depend on the physical environment for support in their daily life. However, the quality of the physical environment is rarely evaluated, and knowledge is sparse in terms of how well the environment meets the needs of older people. This is partly due to the lack of valid and reliable instruments that could provide important information on environmental quality. Aim: The aim of this thesis was to study the quality of the physical environment in Swedish care facilities for older people, and how it relates to residents’ activities and well-being. Methods: The thesis comprises four papers where both qualitative and quantitative methods were used. Study I involved the translation and adaptation of the Sheffield Care Environment Assessment Matrix (SCEAM) into a Swedish version (S-SCEAM). Several methods were used including forward and backward translation, test of validity via expert consultation and reliability tests. In Study II, S-SCEAM was used to assess the quality of the environment, and descriptive data were collected from 20 purposively sampled residential care facilities (RCFs). Study III was a comparative case study conducted at two RCFs using observations, interviews and S-SCEAM to examine how the physical environment relates to older people’s activities and interactions. In study IV, multilevel modeling was used to determine the association between the quality of the physical environment and the psychological and social well-being of older people living in RCFs. The data in the thesis were analysed using qualitative content analysis, and descriptive, bivariate and multilevel statistics. Results: A specific result was the production of the Swedish version of SCEAM. The instrument contains 210 items structured into eight domains reflecting the needs of older people. When using S-SCEAM, the results showed a substantial variation in the quality of the physical environment between and within RCFs. In general, private apartments and dining areas had high quality, whereas overall building layout and outdoor areas had lower quality. Also, older people’s safety was supported in the majority of facilities, whereas cognitive support and privacy had lower quality. Further, the results showed that environmental quality in terms of cognitive support was associated with residents’ social well-being. Specific environmental features, such as building design and space size, were also noted, through observation, as influencing residents’ activities, and several barriers were found that seemed to restrict residents’ full use of the environment. Conclusions: This thesis contributes to the growing evidence-based design field. The S-SCEAM can be used in future research on the association between the environment and people’s health and well-being. The instrument could also serve as a guide in the planning and design process of new RCFs.

Influence of different land uses on groundwater quality in southern Portugal

In Alentejo region, southern Portugal, differences in groundwater samples from six groundwater bodies covered with different land uses were analysed based on the monitoring plan of the Alqueva multi-purpose project, created in the sequence of the construction of the Alqueva Dam on the Guadiana River, in South Portugal. For most of the groundwater bodies there is a statistical significant difference between magnesium, sulphate, chloride, and phosphate. All of these ions are strongly correlated with land use management. Groundwater, where land is covered by olive groves, has high levels of electric conductivity, calcium, potassium, sulphate, and phosphate. Dry land crops are correlated with calcium, magnesium, chloride and consequently, electric conductivity, phosphates and sulphate. Vineyards are strongly correlated with high sulphate and phosphate levels. This study clearly shows that different land uses within a certain groundwater body influence the water quality in a different way. Therefore, an appropriate soil management should be adjusted to each situation, taking into account the aquifer matrix and the overlying soil.

The Scored Patient-Generated Subjective Global Assessment (PG-SGA) and its Association with Quality of Life in Ambulatory Patients Receiving Radiotherapy

OBJECTIVE: To evaluate the scored Patient-generated Subjective Global Assessment (PG-SGA) tool as an outcome measure in clinical nutrition practice and determine its association with quality of life (QoL). DESIGN: A prospective 4 week study assessing the nutritional status and QoL of ambulatory patients receiving radiation therapy to the head, neck, rectal or abdominal area. SETTING: Australian radiation oncology facilities. SUBJECTS: Sixty cancer patients aged 24-85 y. INTERVENTION: Scored PG-SGA questionnaire, subjective global assessment (SGA), QoL (EORTC QLQ-C30 version 3). RESULTS: According to SGA, 65.0% (39) of subjects were well-nourished, 28.3% (17) moderately or suspected of being malnourished and 6.7% (4) severely malnourished. PG-SGA score and global QoL were correlated (r=-0.66, P<0.001) at baseline. There was a decrease in nutritional status according to PG-SGA score (P<0.001) and SGA (P<0.001); and a decrease in global QoL (P<0.001) after 4 weeks of radiotherapy. There was a linear trend for change in PG-SGA score (P<0.001) and change in global QoL (P=0.003) between those patients who improved (5%) maintained (56.7%) or deteriorated (33.3%) in nutritional status according to SGA. There was a correlation between change in PG-SGA score and change in QoL after 4 weeks of radiotherapy (r=-0.55, P<0.001). Regression analysis determined that 26% of the variation of change in QoL was explained by change in PG-SGA (P=0.001). CONCLUSION: The scored PG-SGA is a nutrition assessment tool that identifies malnutrition in ambulatory oncology patients receiving radiotherapy and can be used to predict the magnitude of change in QoL.