Organisations healthcare

Manufacturers and healthcare organisations have a responsibihty to proactively manage clinical risk rather than react only when adverse events occur. 

Effectively managing risk in healthcare and HIT is a complex task but one with incalcnlable rewards for both manufacturers and healthcare organisations. For example ... 

So how does this dilemma translate into HIT and CRM Suppose au organisation knows that an HIT system has a particular defect which introduces a degree of clinical risk. Are the stakeholders involved not duty bound to fix the issue immediately whatever the risk If a patient was to die or experience serious harm as a direct or indirect consequence of the issue would the manufacturer and/or healthcare organisation be immediately negUgent To take this to its logical conclusion, any risk associated with an HIT solution is surely intolerable. 

These publications were based on standards ISO/TR 29322 2008(E) and ISO/TS 29321 2008(E) which had been drafted by CEN/TC251 to address the need for an International Standard for Clinical Risk Management of HIT systems. However the proposed Technical Specification and Technical Report failed to gain formal international ratification. Uptake of ISB 0129 and 0160 in the UK was slow partly due to their complexity and lack of a clear enforcement framework. In 2012 major revisions were undertaken with a focus on separating out requirements and guidance. The result was a set of four easy to use documents (two for manufacturers aud two for healthcare organisations) with content similar to ISO 14971. 

A formal handover of the manufacturer s deliverables at key points in the project to their customer providing a basis for the healthcare organisation to conduct their own risk management activities. NHS procurement policy in England requires healthcare organisations to incorporate compliance with the standard as a requirement in the commercial contract with the supplier. 

Importantly this pair of standards formally recognise for the first time the role of the healthcare organisation in formally managing clinical risk in HIT. Previous standards had focussed almost exclusively on the responsibilities of the manufacturer. With increasingly configurable systems being brought to market, it is not uncommon for the off-the-shelf HIT solution to be a toolkit ready for the healthcare... 

Note that the standard is not intended to be used for assuring networks which provide the infrastructure for general HIT products which are not medical devices. Thus a network used only to support a simple Electronic Patient Record, email and internet access in a healthcare organisation would not typically be included within the scope of the standard. 

Hardware and software - constitutes the physical infrastructure, computer code, user interfaces, operating system and other software dependencies which make up the technical system. These components will typically be assembled according to a strategic architecture drawn np by the manufacturer or healthcare organisation and designed to balance cost, performance, functionality and resilience. 

External influences - Healthcare organisations and system suppliers are influenced by the wider political, cultural, economic and regulatory enviromnent in which they operate. Health policies and objectives change over time and vary geographically. These changes influence local priorities and decision making which impacts the kinds of system which are required, the necessary functionality and the resources available to support procurement, implementation and maintenance. 

Bayuk [7] points out that Employees must fully trust that they will have management support for decisions made in the interest of safety, while also recognising that intentional breaches of safety wiU not be tolerated. The result is a non-punitive environment that encourages the identification, reporting, and correction of safety issues. Developing such a non-punitive culture is a challenge which both healthcare organisations and manufacturers need to embrace. 

Many would say that in the last 10 years a cultural revolution has occurred in healthcare delivery. Organisations in many countries are now more aware than ever of the potential for healthcare to cause harm. In response, most healthcare organisations have put in place measures to identify, report and manage adverse incidents and near-misses along with proactive risk control processes. The challenge for managers of these organisations is to extend this cultural awareness into the implementation of... 

Behaviours observed in similar products in other healthcare organisations or departments... 

The European Commission s report eHealth for Safety summarises that In the case of clinical and organisational decision support systems, internationally, there are over two decades of sound evidence on their benefits [12]. Indeed, large numbers of healthcare organisations are turning to electronic decision support systems to forge consistency in care provision and develop best practice particularly in prescribing. But where clinicians become reliant on decision support to deliver safe clinical care, it is a short step to harm occurring when these systems are found to... 

The potential unavailability of a HIT system should always be anticipated. Whilst its timing may be unpredictable the fact that at some point access to the system will not be possible is virtually inevitable in view of the number of typical dependencies. Architectural and procedural measures can be employed to minimise the risk of unavailability but this should in no way translate into a guarantee of continuous operation. Healthcare organisations need to plan from the very start of a project how they will manage and cope without access to the system for short, medium and long periods. 

Note that in discussing availability and performance one needs to make reference to the stakeholders responsible for hosting the system. In practice this could be the healthcare organisation, software manufacturer or a third party. The principles of fault tolerance and resilience remain the same irrespective of which party takes commercial responsibility. However the stakeholder responsible for implementing controls will vary as will the information available to safety case developers. In this... 

Most systems require at least brief periods of planned downtime in order for technical activities to take place. This often occurs when system components are upgraded to new versions, as a result of hardware changes or alterations in architecture. Early in the lifecycle of a deployment, healthcare organisations will need to liaise closely with the manufacturer to determine the nature, frequency, timing and duration of typical planned outages. 

Systems can often be designed and scaled to meet the requirements of individual organisations. To mitigate the risk of poor system performance healthcare organisations should take appropriate measmes at design time to estimate the numbers of concurrent users. Hosting organisations can use this information to predict the specification and architecture of systan components required to meet performance requirements. 

In many implementations healthcare organisations choose to roll out a system in stages gradually increasing the numbers of concurrent users as different locations... 

Determining the required network bandwidth and architecture is a skilled and complex task. Healthcare organisations often choose to work with reputable partners to install wired or wireless network infrastructnre specific to their requirements. The analysis and design activities which take place around this provide good evidence for performance related controls. 

Similarly the specification of client workstations can also impact the perceived performance at the user interface. In the trend to move to cloud-based architectures the amount of processing undertaken by the client machine is often quite small. However this cannot be assumed and it important that healthcare organisations ensure that local technology meets the minimum specification provided by the manufacturer. Organisations should take into account the fact that client machines could be simultaneously running other software which could compete for processing power. 

---