Very few, if any, senior professionals personally perform all the activities for which they are responsible, and delegation of specific tasks to others who are less well trained and qualified is commonplace. Where long-term, close working relationships exist and supervision is both direct and continuing, it may be possible to maintain high standards of practice without external validation of process. However, in the modern health service, this situation seldom pertains. It is therefore essential that the competence of those carrying out delegated tasks is ensured and that the systems in which they operate are safe. There are several conflicting concerns when the delegation of tasks or the extension of roles is discussed. Some professions will see an extension of their role as something that will provide additional interest and responsibility and may enhance both their status and remuneration. Managers may consider that getting an alternative employee to undertake a task will either be less expensive per se or will allow greater flexibility in staffing. However, those who currently undertake the task may perceive a threat to their status, autonomy and job security, and wish to retain control. Patients and their representatives will not be alone in considering quality of service and safety to be of paramount importance, and at times it can be difficult for those not directly involved to separate genuine concern about safety from elements of job protection. Almost all of the above could relate to many different professions and it is well known that integrating new roles can be difficult.
Anaesthetic practice, in its widest sense, faces a number of challenges in service delivery. It is not feasible, far less affordable, for every patient in the UK who requires sedation to be cared for exclusively by a fully trained anaesthetist. Indeed, it may not be feasible for this to apply to every patient who requires anaesthesia, the establishment of epidural analgesia or the provision of intensive care. How then should the specialty respond to proposals that some of our traditional roles are undertaken by others; what, for example, should we make of reports such as the article in this issue by Edwards et al. , suggesting that it is safe for non-anaesthetists to administer propofol and alfentanil to patients who are undergoing oocyte retrieval?
Administration of sedation by non-anaesthetists under explicit guidelines is not new. Dentists, other medical staff and nursing staff have carried this out in a range of settings for many years. Some departments of anaesthesia run a system of accreditation for the use of sedation by non-anaesthetists in radiology, cardiology, endoscopy, etc. Where a single agent, for example a benzodiazepine, is administered according to a strict protocol such as that set out in ‘Standards for Conscious Sedation in Dentistry’ [2, 3] and verbal contact with the patient is maintained, there is an excellent margin of safety. The availability of a reversal agent (e.g. flumazenil), should the patient become oversedated, might improve this further.
It is not difficult to envisage factors that are likely to decrease the margin of safety. These would include: the provision of what is sometimes referred to as ‘deep sedation’, which may have more in common with anaesthesia than sedation; the use of sedation to allow a procedure to start before local anaesthesia is effective; the lack of provision of facilities that would be considered essential for even the most straightforward general anaesthetic, including proper assistance and supervised recovery; and the combination of several potent drugs, some of which are not reversible pharmacologically.
The administration of propofol, either alone or in combination with other drugs, by non-physicians has been widespread in the USA for some years, although not without criticism . A position statement was issued last year by the American Association for the Study of Liver Diseases, the American College of Gastoenterology, the American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy , and part of that publication reviewed reports in the literature amounting to over 466 000 such administrations of propofol. The safety record appears impressive, with only three deaths directly attributable to the sedation, all in the context of upper GI endoscopy, and all in patients with significant co-morbidity. However, it would be wise to reflect that this experience may not translate directly to sedation for other surgical or radiological procedures, and that the educational background, training, experience and supervision of nurses in the USA will not equate with those elsewhere. It may be difficult to demonstrate which of these attributes is the most important in maintaining safety and thus any introduction of these techniques elsewhere should be subject to rigorous audit.
Whilst appropriate knowledge (of protocols and pharmacology) and technical skills (e.g. airway assessment) are essential prerequisites for safe administration of anaesthesia, there have been incidents where patients undergoing sedation who are being cared for by fully trained anaesthetists have come to harm. The mere presence of a highly trained professional is no guarantee of safety. The whole system of care must be of a standard sufficient to ensure safety, and that will include assessment of the patient, the facilities available and the supporting staff as well as the details of the technique used and the qualifications and experience of the individual administering sedation. The importance of a systems-based approach to safety and the minimisation of error has been well publicised in recent years .
The first consideration for any new or extended role must be whether or not patient care requires it. The process should be driven initially by analysis of service need and scrutiny of the capabilities and capacity of existing and available workers. Covering a shortfall in the service previously provided by one group of workers by a method that produces a shortfall in another group is not sensible. One area where such analysis may fail is in proper consideration of how autonomous those undertaking the new role will be. If it is essential to have the continuous availability of an anaesthetist who can attend immediately if required, then the saving of anaesthetic time may be less than anticipated, unless that individual can undertake some other useful task simultaneously. Not surprisingly, what may work well in one institution may be inefficient in another.
Once the case for service need is established, there will be consideration of the prerequisites necessary: determining who will be trained for the role; establishing a detailed training programme including theoretical and practical instruction; defining how competence is assessed; and defining how performance and maintenance of competence are assured. Care must be taken if those administering sedation are being trained to undertake techniques such as insertion of a laryngeal mask airway in a manikin or in fully anaesthetised patients. This skill may well be appropriate for members of a cardiac arrest team who need to ventilate the lungs of a completely unresponsive patient. However, it may lead to a false sense of security in a sedationist who fails to recognise the increased difficulty in using this device in an oversedated but not anaesthetised patient. Training sedationists to recognise developing problems early and summon help is more important than providing training for skills that may not be at an adequate level to ensure patient safety.
Patient safety may be compromised if individuals trained to a specified but limited level then develop the techniques used, and the manner in which they are delivered, without any formal re-evaluation of the system in which they are working. The limits of practice must be clearly defined, as must the consequences for the individual of any breaches.
For something as widely practised as intravenous sedation, there is surely a strong case to be made for having an agreed framework of the knowledge and skills required rather than leaving individual hospitals and departments to design their own. This would have the advantage that those who had completed training could have this recognised in other hospitals and help ensure a uniform standard of practice.
Consideration should also be given to what other duties those administering sedation will have. It is just as unsatisfactory to have an individual only carrying out this duty on a sporadic and occasional basis as it would be to expect it to form the only duty that he/she ever performed. The new role of Physicians’ Assistant (Anaesthesia) or PA(A) is perhaps one in which moving on a daily basis from one aspect of anaesthetic practice to another would allow continued familiarity with the techniques and equipment used, without leading to boredom.
Many problems with substandard care from health professionals arise from behavioural, rather than knowledge or skill-based, errors. Examination of practice in healthcare as in other industries shows us that error, violations and system migration from the specified standard practice are frequently observed, but as yet this is not well understood. While rigorous audit or logbook assessment may identify some problems, in order to examine safety, consideration must be given to multiple sources of data, and this must continue over time [7, 8]. Now that technology can provide automated records of monitoring data it may be worth insisting that these are obtained and reviewed to ensure that instances such as episodes of oxygen desaturation are not being overlooked or not recorded.
Regulatory authorities recognise that there are inherent risks to patient safety if professionals take on roles and responsibilities that they lack the competence to carry out safely and effectively, or where they practise with inadequate safeguards . Much advanced (nursing) practice does not make statutory regulation essential – rather it reflects career development and is appropriately governed by mechanisms other than additional statutory regulation. Indeed, the Council for Healthcare Regulatory Excellence specifically states that regulatory authorities should not act to denote career progression or professional status . Existing levels of the regulatory framework mean that whatever the level of professionals’ practice, they are always accountable to their regulatory body for that practice. It is also the responsibility of an employer to ensure robust organisational governance for all types of practice that their employees undertake. Where the competences required for extensions of practice are associated with particular qualifications and the risks merit regulatory authority, it is simpler for the regulator to act by linking protection of the title or function directly to the qualification and annotating a register entry. The important decision here is whether providing sedation represents progression within a profession or a fundamental break with the practice of that profession.
We would submit that providing sedation with a combination of drugs, where the margin for ensuring that the patient remains conscious is small or where it is intentional that verbal contact is not maintained, is a fundamental break with the practice of nursing. It may be less so for PA(A)s who will be working on a daily basis with anaesthetised patients. However, regardless of which specific method of regulation is adopted, anaesthetists and their national bodies must be closely involved in defining what they regard as acceptable practice and maintaining that. We should also be clear that a breach of acceptable practice is just as reprehensible in the supervising anaesthetist as it is in the individual to whom a task has been delegated. Anaesthetists should therefore ensure that they are not complicit in arrangements that do not meet agreed standards.
What part should journals such as this play in the process? Patient safety is paramount but some will question whether this is a genuine concern or simply shroud-waving by those with a vested interest in maintaining the status quo. Many comments can be made on either side on the basis of anecdote or personal opinion. It may be easy to find one or several individuals who can safely take on a specific extended role working with defined supervision and support in a particular institution. For a variety of reasons it may not be feasible to replicate that scenario elsewhere. Journals can and should publish the results of studies of such extended roles. Those who do publish will almost inevitably face criticism of what they did and how they did it. Although that is the case with any published research, the political dimension that this issue encompasses may result in more emotive responses. It will be important to argue about facts and the merits or otherwise of analysis and conclusions, and leave political argument and personal attacks to other columns.