Risk Control

Risk control strategies are used in healthcare in highly standardized and regulated environments such as pharmacy, blood products and radiotherapy where there are strict controls built into the delivery systems and restrictions on who can deliver therapies and what competencies they need. Risk control strategies could potentially be used much more widely particularly as a restraint on unnecessary or dangerous informal adaptation. Most importantly they could be used much more explicitly, with greater clarity and embraced as part of the patient safety armament. In this section we give examples of risk control strategies at both frontline and executive levels.

Control of Medication

Restrictions on the prescription and administration of drugs is a classic and widely used risk control strategy. For instance:

• There are clear guidelines about who can and cannot administer intrathecal chemotherapy (Franklin et al. 2014).

• Junior doctors are generally not permitted to prescribe certain drugs such as chemotherapy, oral methotrexate and other substances

• There are legal controls on the use of many drugs such as diamorphine and other opiates

• Nurses have to pass a test of competency to be permitted to administer intravenous medications

These restrictions are generally accepted but not thought of as a risk control strategy or as a patient safety initiative. We list them simply to make the point that risk control is already used and already accepted. The next example is rather different in being an example of the potential for risk control.

Potential for 'Go and No-Go' Controls in Surgery

Pre-flight checks require a conscious decision to proceed, referred to as a “go/ no-go” decision. The civil aviation authorities set clear criteria governing the acceptable conditions for flying and it is expected that aircrew will recognise situations in which risk cannot be adequately managed. In such circumstances they are empowered to cancel the flight and indeed have a clear professional responsibility to do so. In contrast in healthcare the underlying assumption is to cope and carry on even in the face of considerable risk to patients. There are comparatively few areas in which 'no go' is explicitly understood and respected in healthcare.

National guidelines on equipment standards exist in anaesthesia. If faults are detected in core equipment it must be replaced, and if a suitable replacement is not available the case should not proceed without a specific, documented reason (Hartle et al. 2012). There are parallels between aviation and the operating theatre. An operation is a complex process that depends on the correct functioning of a number of different components, both human and technical. There are certain types of equipment failures in which it is assumed no anaesthetist would proceed (for example the airway gas analyser is unavailable), a situation in which some anaesthetists would proceed (an ultrasound is unavailable for a case requiring central venous cannulation), and a situation in which most anaesthetists might be expected to proceed (hospital uninterruptible power supply is unavailable, but all primary systems are functional). In practice however, although specific guidelines exist, there are very few clear 'no go' standards and the decision is left to the theatre team who are inevitably influenced by productivity pressures and other factors (Eichhorn 2012).

'No go' conditions could be defined in surgery to protect both patients and teams by imposing an inviolable limit which can only be bypassed in cases of emergency. 'No go' conditions are objective, absolute, minimum safety standards. They correspond to the thresholds above which activities of care must stop. The no go value correspond to a stage beyond which there is no capacity for safe care whatever the other strategies.

Placing Limits on Care

As we write this section in January 2015 a number of British hospitals have declared a 'major incident'. This does not necessarily relate to any specific incident but is a statement that they have reached crisis point and are unable to cope with the volume or type of patients they are receiving. This can happen in winter when demands are high, but also at other times, for example if there is a major road accident or a large number of older patients with pneumonia. This formal declaration allows the executive team to take a number of steps:

• One of the first measures is to start postponing routine activity, such as knee and hip operations or outpatient appointments.

• Cancelling leave and calling in more staff

• Making announcements to the public that the hospital is under pressure and not to attend the emergency department unless absolutely necessary

• In exceptional circumstances diverting ambulances so no emergency patients arrive. However, this is only used as a last resort as it increases demands on nearby sites.

This is a classic risk control strategy akin to grounding flights when an airport cannot cope with flight volume or in response to bad weather. Many hospitals take these measures in response to crisis but without necessarily having a clear cut prepared strategy in place. Risk control in its fullest sense though demands an explicit, preferably public approach to the problem to allow a considered strategic response rather than an ad hoc muddling through. Again, these critical strategies are not considered in the ambit of patient safety and are not studied, categorised, developed or taught.

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