In the opening presentation of the seminar, Dr Graham Sewell (Research and Technical Services Manager, Plymouth Hospitals NHS Trust) assessed the risks involved in the preparation on an intravenous parenteral product for a patient. He said that the potential for an error to occur existed in every step of the process from the medical practitioner writing the prescription, through compounding the injection, to administering it to a patient.

     Comparing the risks and benefits associated with the preparation of injections on a hospital ward and within a pharmacy CIVAS or satellite unit, Dr Sewell said that, from the limited published information, it appeared that procedures for preparing injections by hospital staff on a ward were poor, and that a large proportion of patients were subject to some form of error when injections were prepared on a ward. The pharmacy-related risk associated with the preparation of total parenteral nutrition solutions in aseptic units had been shown to be low. The available evidence suggested that the risks associated with CIVAS units were low and that this supported the preparation of parenteral products by the hospital pharmacy. However, more quality data were required on which risk assessments could be based.

     Finally, Dr Sewell drew attention to the dual standards that applied to preparing injections on hospital wards and in pharmacy aseptic units and cautioned against the over-regulation or inappropriate regulation of licensed aseptic units.

     Clinical governance was a framework for defining accountability, improving quality and ensuring standards, said Dr Peter Harrowing (Trust solicitor, United Bristol Healthcare NHS Trust). The main components of clinical governance were quality improvement activities, risk management policies, critical incident reporting and complaint procedure that was both accessible to patients and fair to staff.

     In recent years, there had been an increase in the number of negligence claims made by patients. Medical negligence could result from health care professionals acting on their own, gross incompetence, an error of judgement, acting beyond one's competence or a failure of the system.

     In assessing a case of negligence, evidence would be taken from witnesses, expert witnesses and a responsible body representing the profession in question. It would be determined whether local protocols and procedures and local or national guidelines had been followed. If protocols had not been followed, good evidence had to be presented to support an alternative course of action.

     In the event that something did go wrong, individuals should not panic, but should make notes and inform the appropriate consultant and patient.

     Concluding, Dr Harrowing said that the major aspects of clinical governance were a commitment to lifelong learning, encouraging reports of poor performance and giving early indications of problems. Failure to achieve standards might result in penalties being incurred.

     Staff training was an integral part of any strategy for risk reduction in the preparation of injections in aseptic units, Mr Chris Braidwood (Chief Pharmacist, Whiston Hospital, St Helens and Knowsley Hospitals Trust) told the seminar.

     Although the risks were already low, any strategy to reduce them further needed to include staff training. Once a particular task had been identified, it would then be possible to assess the training required to achieve a defined level of operator competence.

     Staff had to be aware not only of what they should do but also why they were doing it. They had to have confidence in their abilities to perform tasks and be supported by more experienced staff. Training that caused staff to work in fear of making a mistake had to be avoided.

     In attempting to provide formal training courses, the greatest obstacle was that the people best placed to train staff - those involved in hospital practice, often within aseptic units, were usually unable to participate in training courses because of work-based commitments.

     Training could be provided within the workplace through the use of validated training procedures, but the means of accrediting that type of training were very difficult. With the move towards lifelong learning for pharmacists and a need for formal documentation of participation in accredited training, the provision of locally or regionally organised courses still appeared to be the most appropriate means of providing training.

     In conclusion, Mr Braidwood stressed that aseptic units needed competent staff, who should be selected accordingly and encouraged if they showed a particular aptitude for that type of work. Training had to be provided and should be continuous to incorporate changes in practice and procedures.

     The objectives of any risk assessment for upper limb disorders (ULDs) had to be to make the job fit the person and would involve a systematic determination of the potential problem, Dr Claire Dickinson (Senior Scientific Officer, Human Factors Unit, Health and Safety Executive), told the aseptic services seminar.

     Dr Dickinson said that the symptoms of ULDs included discomfort, swelling, soreness, stiffness, pain and numbness. Often an indication of the causes of ULDs be gleaned from an examination of an operator's workplace for evidence of unusual wear patterns, the presence of foam pads or other temporary modifications made by the operator to enable tasks to be more easily performed.

     Specific risk factors for ULDs included manipulations requiring force, posture (particularly a static position), high-speed repetitive operations and pressure on tissues. A degree of local knowledge could often be applied to overcome force problems, for example, the use of wide-bore needles to inject viscous liquids into infusion bags.

     Dr Dickinson said that she had examined some isolators and working practices within aseptic units. She considered that the design, shape, size and position of the portholes in isolators could be improved. In addition, the use of devices to support vials inside isolators could reduce strain on the hands of operators.

     Presenting the concepts and uses of capacity planning, Mr Roy Satchell (Business Systems and Logistics Manager, Scherer DDS) said that it was mainly used by the service and manufacturing industries and was a quantifiable method of matching needs (market requirements) with abilities (manufacturing operations).

     To obtain good information from capacity planning required the input of accurate data, particularly data relating to the activities of a process, the sequence of steps, the resources used at each stage, the timing and quantification of each step and personnel and machinery capabilities. Once established, a capacity-planning system had to be continually monitored, with any changes in parameters being fed back into the system.

     Obtaining the maximum benefit from capacity planning required an understanding of the relationships between services, inventory and use.

     Capacity planning could reshape supply and demand and could improve resource management. Accurate process timings were essential if meaningful data were to be generated, and all aspects had to be critically reviewed and updated to take account of any change.

     Capacity planning was primarily a management tool that could be used to give a greater degree of control over a process. Although the principles of capacity planning were logical and simplistic, implementation was not easy. Several computer packages were available which could assist with initiating and running a capacity-planning programme.

     Reviewing the risks of liquid sanitisation procedures in aseptic processing, Dr Ged Lee (Director of Quality Control, Countess of Chester Hospital NHS Trust) said that poor sanitisation of packaging and components could lead to surface contamination of these materials. This might become important when they were passed into an aseptic unit if coupled with poor operator technique.

     Dr Lee compared the advantages and disadvantages of liquid disinfection and gaseous sterilisation and indicated that although good disinfectants were available, they were unsuitable for use in aseptic units. Among the desirable properties of a sanitising agent were that it should be both bactericidal and sporicidal. Alcohols such as ethanol and isopropyl alcohol were bactericidal but were not particularly sporicidal; adding hydrogen peroxide, with or without chlorhexidine, produced solutions that were sporicidal. Chlorine dioxide solutions were sporicidal but many questions remained unanswered regarding this compound's suitability for use in aseptic units and also its toxicity.

     When considering a liquid sanitisation process, a number of questions had to be answered: was a non-sporicidal sanitisation process acceptable; should component surfaces be sterile when passed into an aseptic work zone; how important was the quality of the environment for the sanitisation process; was spraying, immersion or swabbing the most effective disinfection technique; and what were the risks or consequences of process failure. Dr Lee called for more research into this field to generate data to support the practices being adopted in aseptic units.

     If risks in aseptic units were to be managed effectively, it was important that staff should be encouraged to report all errors, Mr Kevin Andrews (Aseptic Services Manager, Burnley Healthcare NHS Trust) said, giving an address on the subject of risk assessment in aseptic units. Efforts had to be made to develop a culture in which making and reporting of errors was not viewed as a negative matter or a disciplinary issue, he said. Invariably, errors were not made deliberately. Most often they were due to system inadequacies or pressure of work.

     It was not possible to identify and completely eliminate all the risks associated with the process, but risks had to be managed effectively. In assessing risks, one had to consider aseptic cabinets, environmental factors, documentation, the types of products prepared, staff abilities and computer systems. Once risks had been assessed, there had to be regular reviews and external audits. Complacency should not be permitted when processes were running smoothly, because there was always room for improvement.

     Mr Andrews was concerned that the current shortage of hospital pharmacists had compounded problems of overwork in aseptic units. He called for the immediate implementation of specialist training for technicians.

     Finally, Mr Andrews suggested that an official forum should be established at which ideas and problems experienced in aseptic units could be shared. This he hoped, would prevent similar incidents occurring at more than one hospital.

     An expansion of research to improve the knowledge base was needed if risks in aseptic practice were to be minimised, Dr Richard Needle (Chairman, National CIVAS Group, and Chief Pharmacist, Colchester General Hospital, Essex Rivers Healthcare NHS Trust) said, in bringing the seminar to a close. To minimise risks, everyone involved in aseptic practice had to have thorough understanding of every aspect of that process.

     Dr Needle hoped that all information currently held and data generated in the future would be made available. If all information could be collated, this could be used to strengthen the case for the preparation of intravenous additives in pharmacy aseptic units.