Clinical Governance - Justification for Introducing Omics Technology in Radiography - Case Study Example

Clinical Governance Business Case Executive Summary National Cancer Centre Singapore (NCCS) is embarked on major upgrade to its radiology infrastructure. Focusing on this aspect, the project comprise introduction of new omics technology in radiography system of NCCS. The development in the existing radiography system is highly important for NCCS, as it would provide several advantages to the organisation. For example, omics technology would allow the researchers to observe at the complete complement of genes, such as its appearance and parameter among others. Furthermore, omics statistics would permit the identification of genes, which alters at high frequency by multiple instruments. It is noteworthy in this context that the incorporation of omics technology in NCCS will be an essential step in order to reap the advantages of advanced and a more accurate radiography. The new system over the traditional system of radiography is expected to increase the level of parallelism further. This project hence supports the rationale and the advantages of improving the radiography services. It is noteworthy in this context that the radiography system needs effective incorporation in order to ensure continuance and development of radiology division in NCCS. The key objectives of interdicting omics technology in radiography are listed as follows: To enable NCCS for delivering unified radiography services To simplify enhanced quality of information management and reporting To ensure proper customisation of radiography functionality To meet the experts’, patients’ and organisational requirements To augment the workflow of radiography To support development in the area of biology and medicine in NCCS To support clinical governance by enhancing the decision making procedure To make sure that diagnostic pictures and reports are accessible when needed To satisfy the ever growing demand of patients regarding radiography services To support future development of radiography by simplifying viable delivery of services To provide justifiable and competitive healthcare services to the patients Clinical Governance Business Case The Case for Change Justification for Introducing Omics Technology in Radiography With the constant increase in human life span, there is increased concern about social and economic effects of future demand of healthcare. Healthcare development is pushing unprecedented burden on social and economic strategies, remarkably, owing to quick rise in the occurrence of age-based circumstances. Ensuring healthy population has therefore become a key priority for NCCS in order to obtain economic efficiency, financial constancy, social involvement and ethics. In this context, it can be stated that biomedicine has a vital role to play in allowing individuals to live longer and a healthier life. In particular, omics technologies have been quite useful in supporting healthcare innovation in the area of radiography in NCCS. Due to this reason, the business case concentrates on introducing omics technology in the area of radiography (Allan, 2013). Rationale for Change Radiography is extensively used in order to treat serious diseases such as cancer, heart disease and tumours among others. It is useful in clinical trials for providing effective diagnosis solutions as well. Radiography is also used for studying anatomy, physiology, pathology and thermography among others. There are extensive diversity of technologies, which are used in radiography, such as X-ray, ultrasound and computed tomography among others in order to identify and treat the above-mentioned diseases. Advancement in this area is taking place with immense rapidity, which is vital to update this field in NCCS (IPD Group, Inc., 2013). In this context, it can be stated that the explosion of omics technology is leading towards drastic changed in radiography practices, revealing personal and individual genotypes, which facilitates modified analysis and treatment (Patuzzi & Zizka, 2014). It is worth mentioning in this regard that Omics technology supports the research of several groups of biological molecules; for example, genome or proteome and is effective in determining as well as developing new solutions for prevention, analysis, observation and treatment of diseases (Joyce & Palsson, 2006). Area of Clinical Governance Introduction of omics technology would generate several clinical governance challenges in NCCS, which must be addressed properly. Correspondingly, the area of clinical governance has been described below: Strengthening of strategic cooperation: In order to overcome the challenges related with the development of radiography in NCCS, a need to strengthen the strategic cooperation can be witnessed. Strengthening of cooperation comprise the creation of new partnership between government, public bodies and private segment for bringing together the resources required for effective implementation of changes in the organisation. There is also a strong requirement for providing support through the implementation of new models of financing and investment in research and development. Furthermore, patients are also regarded as vital actors in the collaboration effort. Support of innovation: Addressing the radiological complexity thus not only necessitates remarkable degree of collaboration from different actors, but also requires establishment of such environment, which can encourage innovation. Notably, innovation in NCCS can be encouraged with the introduction of supportive policies and changing the way of supervisory pathways. Modernisation of regulatory discipline: The innovative solution of radiography is technology oriented and is subject to quick advancement in emerging areas of this particular medical practice. An early and constant dialogue between regulators can effectively circumnavigate an environment of uncertainty. Furthermore, regulatory system should be dynamic and progressive in order to facilitate innovation in the emerging areas of radiography. The Proposal The advent of omics technology such as genomics, metabolomics and proteomics among others has led to substantial developments in the area of radiography. Omics technology is regarded as the complete sequencing of human genome, which escorted into new age of biology and likewise, forms a major part in radiography. The term, ‘omics’, signifies comprehensive evaluation of biological system of human body. It is the study of human body related information such as genome or proteome. Modern use of omics derives from genomics, signifying collectively a set of techniques (Zhang et al., 2010). Recently, in the healthcare segment, particularly in the field of radiography, practitioners are observing new technologies, which are useful for measuring human biology and generating considerable information regarding the same. Various healthcare organisations are presently creating tools for evaluating this information. At present, the area of radiography has become mostly subjected to observations and assumptions, whereby healthcare experts have recognised certain gene and correlated mutation to a certain circumstance. Omics in radiography results in increased information, which can be effective in understanding health conditions of patient in a better way and curing as well as predicting them in future (Zhang et al., 2010). Because of revolutionary improvement in high throughout sequencing technologies, a computational oriented explanation and comparative genomic evaluation have provided healthcare experts with information about functions of gene, genome erections, biological trails, metabolic, regulatory systems and development of bacteriological genomes. However, in order to explain bacterial metabolism and its reaction to environmental aspects completely, it is essential to comprise functional classification and precise quantification of every level of gene products. These efforts resulted in the generation of new omics in the field of radiography. In general, every investigational omics approaches has three key features in comparison with traditional radiography procedures. The first feature is, contrasting to traditional methods, omics methods are high-throughout, data-oriented, all-inclusive and top-down in nature The second feature is that omics methods attempt to comprehend the cell metabolic rate as one incorporated system, rather than mere assortment of different parts by using information of relationships between many measured molecular types The third feature is high-throughout omics provides large amount of information and analysis of such information often necessitate significant numerical and computational efforts (Zhang et al., 2010) While omics approaches are used to evaluate human particle at diverse cellular level, it is quickly becoming accessible. It is also apparent that any single omics method might not be adequate to symbolise the complication of human biological system. For instance, appearance level of a given gene does not indicate the level of protein generated, nor does it indicate the location of protein, biological activity or functional relationship with metabolisms (Zhang et al., 2010). Scope of Implementation Technological advancements have dramatically changed the views on radiography. Traditionally, each gene or protein was evaluated as a single entity. However, the so-called omics technology allows analysis of great amount of genes or protein instantaneously. As a consequence, gene is no longer evaluated as an isolated object, rather it can become a part of complex radiology network. Moreover, the new system would obtain vigorously changing environmental signals and transduce them into observed behaviour of patients. A total network, hence, integrate every element in a cell cooperating with each other. On the basis of such network structure, comprehensive mechanics models can be accumulated, by considering a dynamic behaviour (Keersmaecker et al., 2006). Key Components Notably, there are four key components of implementation of omics technology. Genomics: Genomics signify the examination of every nucleotide structures in the genome. The genotyping technology is quite accurate in evaluation of serious diseases such as cancer. It helps to seek specific biomarkers in relation to the genome alterations such DNA system changes, chromosomal movements and epigenetic alterations among others. The extensively used genomic technologies in radiography comprise Single Nucleotide Polymorphism (SNP) and Next Generation Sequencing (NGS) technology (Zhang et al., 2011). Transcriptomics: Transcriptomics is the most established methods of omics technology. It is the measurement of relative level of every herald RNAs in body in order to determine the outline and degree of gene appearance. A strong technology used in trascriptomics is DNA microarray. It is extensively used in radiography and is not restricted to RNA level (Zhang et al., 2011). Proteomics: Proteomics is the analysis of every protein uttered in a cell, tissue or body, comprising protein isoforms and post-translational alterations. Proteomics approach is divided into two groups; one being gel-oriented proteomics and the other being gel-free proteomics. In gel-oriented proteomics, proteins are separated and quantified by two-dimensional gels, in order to recognise human particles of interest. On the other hand, gel-free proteomics comprise collective utilisation of ‘Multidimensional Liquid Chromatography’ (MDLC) for the evaluation of human particles (Zhang et al., 2011). Metabolomics: Metabolomics examine the pattern of biological agitations caused by any disease in human. It signifies inclusive evaluation of every metabolite produced in a given biological system and concentrates on capacity of metabolite as well as excretions in cells and tissues (Zhang et al., 2011). Relationship with Clinical Governance Omics technologies for radiography can potentially identify diseasing risks, minimising disease burden and delivering better and cost-efficient methods of healthcare. However, the promise of omics technology would remain unsatisfied for NCCS unless capacities for utilisation and integration are created. Implementation of omics can generate certain clinical governance issues in NCCS. For example, NCCS would require authenticating alternate models and develop beneficial strategies for implementation of omics technology. Moreover, NCCS shall also necessitate exceptional degree of cooperation along with investment in research and development. National as well as global cooperation would therefore assist in focusing on different actors on single strategic objectives of the development in radiology (Huzair & Borda-Rodriguez, 2012). In order to implement omics technology, there is a substantial need to accelerate the allocation of knowledge and technology from laboratory centred to patient centred. These efforts comprise fostering innovative partnerships with public and private entities in order to accumulate the resources required for efficient implementation (Huzair & Borda-Rodriguez, 2012). There is also immense importance of developing new schemes funding and risk management in the governance practices of NCCS. More innovative strategies for sharing the risk can be developed on the basis of large associations with various healthcare organisations. Such associations would permit risk sharing between organisations and help to manage uncertainty when bringing new technology oriented solutions to NCCS. Together these initiatives would provide the basis for developing and authenticating new system in NCCS (Huzair & Borda-Rodriguez, 2012). Boundaries There are several boundaries, which can hinder the utilisation of omics technology. Firstly, in order to utilise omics in radiography, there is need to establish clinical validity and utility of genomic tests and quality assurance Secondly, there is need to develop clear authorising principles for genomics and clinical genetic testing within clinical paths by providing an open and widespread procedure for healthcare experts to request radiological tests and to obtain outcomes with maximum accuracy Thirdly, there is also need to develop a safe and vigorous bioinformatics structure to allow quick, inexpensive evaluation of genomic individual information Fourthly, a strong workforce is necessary with abilities and knowledge for making effective utilisation of omics technology (European Commission, 2010) Options Assessment Fundamentally, there are three options for NCCS, wherein one is to remain status quo, the second one is to procure and install standard omics technology and the third one is to procure and install customised omics technology. The cost benefit analysis along with the risk of each option has been described in the following table accordingly. Option Cost Benefit Risks Option 1: Status Quo Only annual charges of radiographic facilities No additional expenses No requirement of additional training for workforce development No data migration Constant stability of existing services of NCCS No technological development Unreliable digital dictation of diseases Reliant on traditional functioning of radiology Inability to record every radiological activity Improper integration of radiography and scanned request Data are quite difficult to obtain and time consuming in nature Option 2: Procure and install standard omics technology Estimated cost of about £100,000 New system to adapt the method of working of NCCS Capable to pull data rapidly and easily Will enable better examination of genes Keep complete record of radiology activity Effective collection of radiology information for making statistical report Centralised clinical information system Expenses for implementation Require training for the workforce Old data require to be migrated in the new system No alternative in the product selected Might not adjust to the old system or requirements Service providers unable to provide 24 hour support Data migration undertaken by the third party Time necessary in order to procure and install new technology Require commitment from other organisations in the supportive industry in order to implement new technology successfully Option 3: Procure and install customised omics technology Estimated cost of about £150,000 The new technology would be tailored to the usual way of working of NCCS Capable to pull statistics rapidly and easily Will enable better examination of genes Keep complete record of radiography activity Notation could be completely central and would minimise the number of vendors when there is any problem Multidirectional link to radiology information Effective collection of radiology information for making statistical reports Capable to access the market and observe at extensive range of technologies in order to make knowledgeable choice Possible implementation of new generation system with additional advantages Centralised clinical information system Every employee is required to be retrained Extensive expenses of implementation and customisation Old information requires migrated in the new system Time consumed to procure, install and customise new technology Require resources and commitment from the IT department in order to be implemented properly By considering the three options for the new project, it is recommended that NCCS should follow the third option, i.e. procurement and installation of customised omics technology. Omics technology already has several advantages in the area of radiography. Moreover, implementing new omics technology, NCCS can obtain enhanced quality of information, supportive business procedure and improved imaging services (Joyce & Palsson, 2006). Risk Management The recognition of risk usually begins before the project is introduced and the number of risks grows as the project advances through the lifecycle. Whenever a risk is recognised, it is first assessed to ascertain the probability of occurring, the level of impact to the schedule and the expenses among others. The probability of occurrence and the extent to which it influences the project is the basis for evaluating risk priority. In order to implement omics technology, NCCS would have to face five key risks, namely the use of unverified technologies, system requirements, new system architecture, system performance and organisational & non-functional areas (see appendix 1). Use of unverified technology: The most important risk in the second and third options is related with the problem of new technologies. Improper use of new technology can result in failure of the project. It is worth mentioning in this context that knowledge is the key issue, which is related with the use of new technology in the area of radiography. Thus, in order to implement omics technology, the development team must possess sufficient understanding regarding the same. The significance of knowledge regarding the use of new technology involves system development project, wherein the developmental solution is established on new technological features, which are generally new for any project development team. The technological feature of omics technology would correspondingly be predicted at the beginning of the development project and only a prototype of the new system can establish such prediction. The understanding about technological features can enhance predictions regarding features and reduce the risks related with the use of omics technologies in radiography. The system development team should therefore possess significant understanding in order to exploit technological features effectively, for the benefit of the project (Boban et al., 2003). System requirements: The second vital risk is related with system requirements. System requirements are commonly used to refer users’ necessities about system functionality and service quality. It is often quite challenging to develop proper technological solutions, which can absolutely satisfy organisations’ anticipations. In order to develop solutions in accordance with organisational expectations, system development team should discover entire set of organisational requirements. These requirements would further guide the entire developmental procedure being classified into two groups, namely functional requirements and non-functional requirements (Boban et al., 2003). New system architecture: The third significant risk area is new system architecture. System architecture could be demarcated as a set of vital decision regarding organisation and the elements of new technology. The new system architecture is required to be described in the initial development stages in order to establish quality technological solution. It is likely that system architecture described in initial development phases do not fulfil every requirement of technological solution. Hence, to mitigate this issue, the system architecture can be confirmed by software prototype, which can be realised in later development stages (Boban et al., 2003). System performance: The fourth risk is related with system performance. In order to fulfil the non-functional requirements, technological solutions must have satisfactory performance. The performance of system can herein be evaluated on real and comprehended technological solutions. Hence, it is essential to make forecasts regarding software system performances in the initial development phases. These forecasts are quite significant as it is possible to develop technological solution, which fulfils the functional requirements, but is sluggish to satisfy software performance requirements. Hence, it is vital for developmental team to have much experience in omics technologies and make proper forecasts and expectations regarding the performance of the new system (Boban et al., 2003). Organisational and non-functional risks: The fifth risk is organisational and non-functional risks. The risks related with these fields are defined as organisational issues and problems associated with project resources and timetable forecasts. Contextually, organisational issues can influence the realisation of technological solution since only the effective administration of system development result in successful project. A clear project timetable can also become a risk, as there are several undesirable occurrences, which may cause delay in system realisation. It is the administration problem to describe project timetable for fulfilling both the requirements of patients and NCCS. In order to meet project deadline, resources provided to the project must be adequate. This signifies that every system should have adequate project members with proper competencies and all the mandatory resources for planned achievements (Boban et al., 2003). Risk Management Strategies Apart from risk identification and description, risks associated with the implementation of omics technology are undoubtedly required to be managed properly. In system development project, there are several ways of dealing with risks. On the basis of degree of impact and type of risks, they can be avoided, constrained, alleviated or observed (see appendix 2). In this context, it can be stated that the best way of addressing risks is to avoid it completely. There are several risks, which can be avoided completely through proper utilisation of different technologies and by changing the specific requirements of the project plan. The next best method to deal with the risk is to constrain them. Risks can be constrained to influence on small field of the system development project. In order to minimise the risk influence field, risks should be recognised and certain changes should be made on technology and utilisation of resources. This is the appropriate strategy for dealing with such risks, which cannot be avoided (Boban et al., 2003). On the other hand, there are certain risks, which cannot be constricted and thus, such risks are required to be alleviated. Certain risks can be alleviated with the realisation of system prototype in order to perceive the chances of their possible occurrence. It is better that risks appear during the prototype development than on the real system solution, since system development team can learn from the risks perceived in a prototype and find way to alleviate or constrict them (Boban et al., 2003). If the risks cannot be alleviated, they should be observed constantly in order to track their appearance. For these types of risks, emergency plan should be developed for describing activities to be taken if they appear. The risks that cannot be alleviated present serious threats to the new technology implementation project and thus, should be considered as highly significant. After occurrence of such risks, a comprehensive project evaluation and decision regarding the future of project must be taken. Risks can be recognised and located in diverse stage of a project; however, it is vital to identify them as soon as possible and address them rapidly due to expenses related and the coverage of risks can be vast (Boban et al., 2003). Recommendations In order to enhance the radiography services, the third option is possibly the effective way for NCCS. If NCCS was to select the third option, proper monitoring and evaluation framework should be followed. Monitoring and evaluation in the introduction of omics technology comprise several different elements. However, in general, the monitoring and evaluation framework can be described as obtaining, evaluating and making use of proper, accurate, timely and affordable information for the purpose of project accomplishment and development. Furthermore, as it is often regarded as the cornerstone for designing and implementing effective omics technology in radiography, monitoring would provide information regarding policy and the project at given time and provide a view regarding the condition of project status. On the other hand, evaluation would provide information regarding whether or not certain activities are working, i.e. accomplishing the intended objectives. Thus, proper monitoring and evaluation frameworks should be followed when implementing the project in order to ensure that the change objectives are fulfilled. In this context, it can be stated that NCCS should utilise a tiered approach for monitoring and evaluating the implementation project efficiently (see appendix 3). References Allan, J. (2013). Integrating omics and policy for grand challenges: healthy ageing. Retrieved from http://www.cesibiotech.com/files/+10_%20Integrating_Omics_and_Policy_for_Grand_Challenges_Healthy_Ageing_%20DSTI_STP_BIO(2013)14.pdf Boban, M., & Požgaj, Z., &Sertić, H. (2003). Strategies for successful software development risk management. Management, 8(2), 77-91. European Commission. (2010). Omics in personalised medicine. Retrieved from http://ec.europa.eu/research/health/pdf/summary-report-omics-for-personalised-medicine-workshop_en.pdf Huzair, F., & Borda-Rodriguez, A. B. (2012). Challenges for the application and development of omics health technologies in developing countries. Drug Development Research, 73, 447-451. IPD Group, Inc. (2013). An insight to advanced radiology and imaging techniques - omics group medical conferences. Retrieved from http://events.einnews.com/pr_news/158446125/an-insight-to-advanced-radiology-and-imaging-techniques-omics-group-medical-conferences Joyce, A. R., & Palsson, B. O. (2006). The model organism as a system: integrating ‘omics’ data sets. Nature Publishing Group, 7, 198-210. Keersmaecker, S. C. J., Thijs, I. M. V., Vanderleyden, J., &Marchal, K. (2006). Integration of omics data: how well does it work for bacteria? Molecular Microbiology, 1-12. Patuzzi, J., & Zizka, D. (2014). Role and recent progress of radiology in personalised medicine. Retrieved from https://www.myesr.org/html/img/pool/Kauczor_Hans-Ulrich_ECR_2014_Press_Conference.pdf Zhang, W. (2010). Integrating multiple ‘omics’ analysis for microbial biology: application and methodologies. Microbiology, 156, 287-301. Zhang, X., Shi, L., Chen, G., &Yap, Y. L. (2011). Integrative omics technologies in cancer biomarker discovery. Retrieved from http://www.landesbioscience.com/pdf/11Zhang_Zhang.pdf Appendices Appendix 1 Risk Quantification Appendix 2: Risk Activities Activities Impact No action is required Low Observation as required in order to ensure that risks are being properly managed Medium low Observation as required as such risks are less important but still could have a serious influence on the provision of key services Medium Alleviated as these risks may potentially influence the provision of key services Medium high Constrained as required as these risks may potentially influence the provision of important services High Avoided as possible because these risks can pose serious threat to the accomplishment of important services Critical Appendix 3: Monitoring and Evaluation Framework Read More