A protocol for the reduction of surgical errors.

M edical errors make headline news. The headlines will always emphasise the human suffering associated with medical error, but the prevention of such errors comes as the result of detailed analysis of their circumstances. One area of particular concern to surgeons is wrong site/wrong side surgery. Although its occurrence is rare, it is potentially avoidable. A notable recent case in the UK was that of a patient who died from renal failure after the removal of his healthy kidney and not his diseased one. Worldwide systems should be in place to prevent this occurring, but the data revealing the extent of the problem have not been readily available. In the past there has been little opportunity to understand the cause of errors as such events—although rare— were often not reported and not collated with other similar events, preventing their repeated recurrence. Not surprisingly, doctors were often reluctant to disclose such errors or ‘‘near misses’’. But attitudes and practices are changing. In the USA the Joint Commission on Accreditation of Healthcare Organizations (JCAHO; www.jcaho.org; see box 1) has shown that, by the voluntary reporting of serious errors to a central body, these events can be analysed. This has revealed not only the relative rarity of wrong site/wrong side surgery, but has also allowed the pooling of data and their analysis, permitting guidelines to be drawn up to prevent their potential recurrence. When retrospective studies are undertaken, these suggest that at least 5–10% of hospital admissions will suffer an adverse event. By inference and extrapolation, this would imply that 1.3 million people in the USA are harmed annually and in the UK the figure would be over 400 000. Within these figures, surgery is rated the highest risk factor for all adverse events. Root cause analysis of medical errors leading to adverse events reveals them to be multifactorial. In the case of wrong site surgery, this will involve a breakdown in communication between members of the surgical team and the patient and his/her family. Contributory factors will include problems with the routine process of ‘‘site marking’’ (that is, marking the site of the operation with indelible ink before anaesthesia), failure in the verification of a preoperative checklist, incomplete patient assessment, missing patient notes, distraction, and various other organisational issues. However, a major problem with these retrospective studies is that it is difficult to obtain ‘‘real time’’ information regarding the circumstances. In the USA the JCAHO has been supporting a voluntary reporting system since 1996 that potentially allows clinicians to report errors as they occur; it also examines other sources such as the media. This information is collated and examined and reported as a periodic newsletter called Sentinel Event Alerts which describes common causes and suggests steps for elimination and prevention of their recurrence. This includes not just wrong site surgery but also other areas such as medication errors, blood transfusions, and postoperative complications. For wrong site/wrong side surgery the JCAHO has so far reported 150 cases, with root cause analysis available for 126: 75% were on the wrong body part or site, 13% were for wrong patient surgery, and 11% for the wrong surgical procedure. Over 80% of these incidents were self-reported, with the remainder arising mainly from patient complaints. In New York State, where a mandatory system for reporting is in place, there were 46 cases in 2 years, which suggests that these voluntary figures could be a vast underestimate. A recent survey of hand surgeons in the USA found that at least 20% of them had undertaken wrong site surgery at least once in their career, and a further 16% had only avoided this at the time of incision. This reinforces the necessity for prospective reporting. From their analysis of prospective reporting of wrong site surgery, the JCAHO has issued the ‘‘Universal protocol for preventing wrong site, wrong procedure, wrong person surgery’’ which has been endorsed by the major American medical associations. These recommendations stress the importance of risk reduction strategies including checking and rechecking. The marking of the surgical site should involve the patient; the use of verification checklists and the availability of the appropriate documents such as notes and x rays; verification by the patient of the site in the operating theatre complex; and the monitoring of these processes; a final time out is suggested before starting the procedure with active communication involving the whole operative team. An important concept promoted by the protocol is the active involvement of the patient in the process. This requires the clinical team to involve patients in decisions about their care. In the UK this could be extended to include a second patient signature on the consent form to confirm, where appropriate, that the site or area marked is correct to the best of the patient’s knowledge. At present in the UK there are no nationally applied guidelines or protocols regarding site marking; local practice often requires that the nursing staff merely document that the site or side is marked, but the operating surgeon ultimately takes responsibility and this potentially provides a source of individual error. It is clearly important that, if errors occur, lessons should be learnt to prevent their recurrence. The JCAHO approach has shown that, with voluntary collection, it is possible to capture details of errors in ‘‘real time’’, although this may not reflect the true incidence of errors. Analysis of the information provided by the clinicians reporting the errors can aid the development of guidelines aimed at preventing their recurrence. In the UK the National Patient Safety Agency (www.npsa. nhs.uk) is developing a national reporting system for patient safety incidents which is being implemented in England and Wales—the National Reporting and Learning System (NRLS). This has been trialled by 39 health service organisations and is in the process of being rolled out nationally. The aim is to identify recurrent patterns of behaviour and practice associated with errors and to feed this back to ensure safer care. It is envisaged that, by encouraging the reporting of errors, their number will decline, paralleling the airline industry. However, it should be recognised that, despite increasing technical reliability, human error can never be totally removed. The reporting of medical errors in ‘‘real time’’ will reveal a truer picture of their frequency. This offers the potential of providing solutions that will reduce the risk or even prevent their occurrence 162 EDITORIALS