Are clinical documents optimised for patient safety? A critical analysis of patient safety outcomes using the EDA error model

Iatrogenic errors and patient safety in clinical processes are an increasing concern. The quality of process information in hardcopy or electronic form can heavily influence clinical behaviour and decision making errors. Little work has been undertaken to assess the safety impact of clinical process planning documents guiding the clinical actions and decisions. This paper investigates the clinical process documents used in elective surgery and their impact on latent and active clinical errors. Eight clinicians from a large health trust underwent extensive semi- structured interviews to understand their use of clinical documents, and their perceived impact on errors and patient safety. Samples of the key types of document used were analysed. Theories of latent organisational and active errors from the literature were combined with the EDA semiotics model of behaviour and decision making to propose the EDA Error Model. This model enabled us to identify perceptual, evaluation, knowledge and action error types and approaches to reducing their causes. The EDA error model was then used to analyse sample documents and identify error sources and controls. Types of knowledge artefact structures used in the documents were identified and assessed in terms of safety impact. This approach was combined with analysis of the questionnaire findings using existing error knowledge from the literature. The results identified a number of document and knowledge artefact issues that give rise to latent and active errors and also issues concerning medical culture and teamwork together with recommendations for further work.

The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease.

Huntington's disease (HD) is a fatal autosomal dominant neurodegenerative disease involving progressive motor, cognitive and behavioural decline, leading to death approximately 20 years after motor onset. The disease is characterised pathologically by an early and progressive striatal neuronal cell loss and atrophy, which has provided the rationale for first clinical trials of neural repair using fetal striatal cell transplantation. Between 2000 and 2003, the 'NEST-UK' consortium carried out bilateral striatal transplants of human fetal striatal tissue in five HD patients. This paper describes the long-term follow up over a 3-10-year postoperative period of the patients, grafted and non-grafted, recruited to this cohort using the 'Core assessment program for intracerebral transplantations-HD' assessment protocol. No significant differences were found over time between the patients, grafted and non-grafted, on any subscore of the Unified Huntington's Disease Rating Scale, nor on the Mini Mental State Examination. There was a trend towards a slowing of progression on some timed motor tasks in four of the five patients with transplants, but overall, the trial showed no significant benefit of striatal allografts in comparison with a reference cohort of patients without grafts. Importantly, no significant adverse or placebo effects were seen. Notably, the raclopride positron emission tomography (PET) signal in individuals with transplants, indicated that there was no obvious surviving striatal graft tissue. This study concludes that fetal striatal allografting in HD is safe. While no sustained functional benefit was seen, we conclude that this may relate to the small amount of tissue that was grafted in this safety study compared with other reports of more successful transplants in patients with HD.

The national food safety control system of China: a systematic review

In recent years, there have been increasing concerns over the safety of the Chinese food supply. Although many of these have only raised concern internally within China, several major food safety issues have had international repercussions. In response, China has implemented new food safety laws and management systems to improve its national food safety control system and reduce public and international concerns. This paper has describes and discusses the components of the Chinese system using the five key elements of a national food control system identified by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) as essential for an effective system. The latest Chinese national food safety control has made significantly improvement on its regulation framework, however, more work need to be done on standards, law enforcement, and information exchange.

A decade of plant proteomics and mass spectrometry: translation of technical advancements to food security and safety issues

Tremendous progress in plant proteomics driven by mass spectrometry (MS) techniques has been made since 2000 when few proteomics reports were published and plant proteomics was in its infancy. These achievements include the refinement of existing techniques and the search for new techniques to address food security, safety, and health issues. It is projected that in 2050, the world’s population will reach 9–12 billion people demanding a food production increase of 34–70% (FAO, 2009) from today’s food production. Provision of food in a sustainable and environmentally committed manner for such a demand without threatening natural resources, requires that agricultural production increases significantly and that postharvest handling and food manufacturing systems become more efficient requiring lower energy expenditure, a decrease in postharvest losses, less waste generation and food with longer shelf life. There is also a need to look for alternative protein sources to animal based (i.e., plant based) to be able to fulfill the increase in protein demands by 2050. Thus, plant biology has a critical role to play as a science capable of addressing such challenges. In this review, we discuss proteomics especially MS, as a platform, being utilized in plant biology research for the past 10 years having the potential to expedite the process of understanding plant biology for human benefits. The increasing application of proteomics technologies in food security, analysis, and safety is emphasized in this review. But, we are aware that no unique approach/technology is capable to address the global food issues. Proteomics-generated information/resources must be integrated and correlated with other omics-based approaches, information, and conventional programs to ensure sufficient food and resources for human development now and in the future.

An industry viewpoint on the role of farm assurance in delivering food safety to the consumer: the case of the dairy sector in England and Wales

Food safety, alongside food quality, remains a primary concern of both consumers and those along the whole food supply chain, leading to regulation by government alongside private third party certification. Much has been written about the value of these systems primarily from the perception of the consumer. This paper reports on a study that examined industry perceptions on the regulatory and assurance systems within the dairy sector of England and Wales. It found that the primary producer found value in both systems, although from a food hygiene focus regulation was seen to be more rigorous. Other stakeholders along the dairy food supply chain saw the assurance scheme as more rigorous. All stakeholders recognised the need to reduce duplication in delivering food safety through combining key elements of both systems with the added potential for better communication of both food safety and quality to the final consumer.

Revolution blues: the reconstruction of Health and Safety as a ‘common-sense’ form of regulation

This paper provides a review of the last five years of policymaking in the area of health and safety law; this includes multiple reviews, legislative reform, and the reframing of rhetoric around the issue. It characterises this as a process of social construction of a new ‘universe of meaning’ around health and safety regulation, which provides a basis for a particular, narrow, neoliberal conception of regulation and responsibility to permeate the mainstream. Deliberative and public-facing policymaking processes have been utilised as a key element of this process.

Work Domain Analysis for understanding medication safety in care homes in England: an exploratory study

Medication safety and errors are a major concern in care homes. In addition to the identification of incidents, there is a need for a comprehensive system description to avoid the danger of introducing interventions that have unintended consequences and are therefore unsustainable. The aim of the study was to explore the impact and uniqueness of Work Domain Analysis (WDA) to facilitate an in-depth understanding of medication safety problems within the care home system and identify the potential benefits of WDA to design safety interventions to improve medication safety. A comprehensive, systematic and contextual overview of the care home medication system was developed for the first time. The novel use of the Abstraction Hierarchy (AH) to analyse medication errors revealed the value of the AH to guide a comprehensive analysis of errors and generate system improvement recommendations that took into account the contextual information of the wider system.

Seafood safety and quality: an analysis of the supply chain in the Sultanate of Oman

The globalization of trade in fish has created many challenges for the developing world specifically with regard to food safety and quality. International organisations have established a good basis for standards in international trade. Whilst these requirements are frequently embraced by the major importers (such as Japan, the EU and the USA), they often impose additional safety requirements and regularly identify batches which fail to meet their strict standards. Creating an effective national seafood control system which meets both the internal national needs as well the requirements for the export market can be challenging. Many countries adopt a dual system where seafood products for the major export markets are subject to tight control whilst the majority of the products (whether for the local market or for more regional trade) are less tightly controlled. With regional liberalization also occurring, deciding on appropriate controls is complex. In the Sultanate of Oman, fisheries production is one of the countries' chief sources of economic revenue after oil production and is a major source of the national food supply. In this paper the structure of the fish supply chain has been analysed and highlighted the different routes operating for the different markets. Although much of the fish are consumed within Oman, there is a major export trade to the local regional markets. Much smaller quantities meet the more stringent standards imposed by the major importing countries and exports to these are limited. The paper has considered the development of the Omani fish control system including the key legislative documents and the administrative structures that have been developed. Establishing modern controls which satisfy the demands of the major importers is possible but places additional costs on businesses. Enhanced controls such as HACCP and other management standards are required but can be difficult to justify when alternative markets do not specify these. These enhanced controls do however provide additional consumer protection and can bring benefits to local consumers. The Omani government is attempting to upgrade the system of controls and has made tremendous progress toward the implementation of HACCP and introducing enhanced management systems into its industrial sector. The existence of strengthened legislative and government support, including subsidies, has encouraged some businesses to implement HACCP. The current control systems have been reviewed and a SWOT analysis approach used to identify key factors for their future development. The study shows that seafood products in the supply chain are often exposed to lengthy handling and distribution process before reaching the consumers, a typical issue faced by many developing countries. As seafood products are often perishable, they safety is compromised if not adequately controlled. The enforcement of current food safety laws in the Sultanate of Oman is shared across various government agencies. Consequently, there is a need to harmonize all regulatory requirements, enhancing the domestic food protection and to continue to work towards a fully risk-based approach in order to compete successfully in the global market.