The Institute of Medicine's 2000 report To Err is Human
] showed that, in approximately 10% of hospital admissions, adverse events were described. Reporting CIs was described as a crucial factor in raising awareness about safety issues in medicine. Since then, incident reporting has been instituted in health-care systems in several countries. An effective incident reporting system facilitates early detection of factors related to causation and prevention of CIs in critical care areas. In addition, discussion of and feedback on CIs help to promote a culture of safety and learning [10
]. A growing body of studies on CI reporting has been published in recent years, but only a few publications analyze large data sets [11
] or longer observation periods. Many reports refer to CI reporting in anesthesia [12
], but little evidence about the distribution of CIs in intensive care is available. Thus, the aim of our study was to identify the main areas in which CIs are regularly reported in intensive care. In our study, we analyzed 1,127 CIs reported over the course of a 90-month period after the introduction of a CI reporting system.
As part of our standard practice, all reported CIs were reviewed and discussed at monthly morbidity and mortality meetings to identify events that require immediate action. However, to establish frequency and recurrence of specific CIs, a longer observation period was required. In accordance with the hospital's policies, all CIs that led to major harm to patients or staff were investigated by root cause analysis. Amendment of guidelines and additional staff training sessions relating to the CI are examples of immediate -responses to CIs associated with severe patient harm. Specific CIs that triggered such changes include hypoglycemia associated with intravenous insulin administration and the dislodgement of central lines because of insufficient fixation.
The largest fraction (30%) of reported CIs was related to equipment, and one third of reports referred to faulty equipment (113 events). This is considerably lower than the percentage of equipment dysfunction reported to the National Patient Safety Agency: more than 50% of CIs associated with equipment were related to malfunction [13
]. Dislodgement, disconnection, or leak of catheters and tubes as well as the unavailability of equipment were also common; 65 and 64 CIs, respectively, were reported. Incorrect handling (61) and unfamiliarity (11) were the second and third leading causes for reporting CIs related to equipment. In an attempt to address these equipment-related CIs, an equipment group was established to serve as a point of contact to discuss the purchase of new equipment as well as recurrent equipment faults and equipment-related safety concerns. In addition, training issues and handling errors were addressed by introducing a practice educator to follow up CIs related to these particular subgroups. The practice educator's role was to ensure the introduction of equipment to new staff as well as continuous education in the use and handling of all equipment available on the unit. After the appropriate training and an introduction to equipment, users' names were entered into a database against the relevant medical devices to record users' familiarity with them. Further studies to assess the change in equipment-related CIs after introduction of the practice educator are under way. Although there was an increase in equipment-related CIs during the first 6 years of reporting, no significant time correlation could be established.
The second largest proportion of CIs in our data set refers to clinical practice. Although no agreed-upon classification system exists so far [14
], it has to be acknowledged that this category comprises a heterogeneous group of CIs such as pressure sores, handling of specimens, infection control, and airway management. Medical complications after interventions, also termed procedural complications [14
] (for example, brachial plexus injury and pneumothorax); diagnostic errors; and omission of required investigations (for example, blood glucose monitoring and chest x-ray) were all listed under clinical practice. Failures to comply with management or diagnostic guidelines (for example, review of chest x-ray after line insertion or no monitoring of depth of neuromuscular blockade in patients receiving neuromuscular blocking agents) were summarized under the heading of poor practice. CIs relating to clinical practice can potentially be addressed by continuous education of medical and nursing staff as well as by providing easy access to guidelines and unit policies. Further studies will be required to assess the impact of the introduction of a dedicated practice educator on the incidence of these CIs.
Medication errors comprise a major proportion of CIs in critical care and account for 78% of serious medical errors [3
]. Incidents involving pharmaceuticals can be defined as any error in the medication process, including prescription, transcription, preparation, dispensation, and administration of drugs. The consequences of drug-related errors such as increased mortality, morbidity, and hospital length of stay have been outlined in two publications [1
]. Our data confirm that medication errors are common in the ICU. It remains unclear, however, to what degree they contribute to mortality and morbidity in our patient cohort. Standardized drug concentrations and routine checks at shift change are recognized strategies to reduce the number of medication errors and represent standard practice in our ICU. All prescription charts are checked daily by a dedicated intensive care pharmacist to minimize prescription errors. This might explain why in this study - in contrast to other studies [11
] - medication errors were not the commonest reported type of CI.
The fourth major group (18.9%) of incidents consisted of administrative issues and was in nearly two thirds of cases (63.4%) related to staffing, shortage of beds, and delays in admission and discharge. Two studies indicate that a staffing shortage poses a major risk to patient safety [18
], although adjustment for confounding factors may weaken the evidence [20
]. In particular, prevention of ventilation-associated complications such as unplanned extubations, ventilator-associated pneumonia, and non-compliance with lung-protective tidal volumes requires high nurse-to-patient ratios [21
]. Current recommendations, therefore, claim one nurse for each patient as the gold standard in critical care nursing [23
]. Local policies suggest closure of ICU beds if a one-to-one nurse-to-patient ratio is not achieved. Shortage of ICU beds, however, represents another major proportion of CIs. This observation may reflect the nationwide situation since the UK has the lowest ratio of ICU beds per 100,000 population in Europe [24
]. Reporting of staffing and bed shortage and delayed discharges and admissions may help to quantify the actual infrastructural requirements of local and regional ICU services and allow inter-regional and nationwide comparisons.
The remainder of incidents included injuries and safety hazards (7.2%), including slips, trips, and falls, and environmental issues (2%) related to alarms, water supply and pipes, air conditioning, doors, and waste disposal; together, these represented only a small proportion of all incidents reported. It worth noting that a high number of staff injuries were reported. It is likely that staff injuries, mainly needle-stick injuries, are reported more frequently because of medico-legal consequences for the staff member if the incident is not documented. Hence, it seems likely that under-reporting occurs less often when staff injury is involved.
Our study has several limitations. Under-reporting is a common problem associated with documentation of CIs [25
]. The fear of reprisal appears to be the main cause for reluctance to report CIs [26
]. In an attempt to minimize under-reporting, we have deliberately chosen to retain paper-based CI reporting, which protects anonymity. We did not find an increase in the numbers of CIs reported during the study period. This could be due to either a lack of under-reporting or an insufficient endeavor to quantify under-reporting. A questionnaire survey performed on our unit revealed that less than a quarter of staff have reported a CI within the last month and that the average time that had passed since the last CI report was 24 weeks. We have aimed to reduce under-reporting by promoting a non-punitive and non-confrontational atmosphere. This process included the introduction of multi-disciplinary safety meetings to facilitate communication among doctors, nurses, and other staff to create a culture of 'speaking up'. The first results of these changes are evidenced by an increased reporting rate in our ICU compared with that in other departments within this hospital and a higher reporting rate in our ICU compared with that in other ICUs within our region. In addition, the rate of 10 to 15 CI reports per month in our unit is significantly higher than those in previous reports, in which inclusion of 306 health-care facilities led to only 94 reports per year [27
A recent study investigating the temporal trends in patient harm concluded that harm remains common with little sign of improvement [28
]. This indicates that analysis of large CI databases can constitute only the first step in learning and improvement. It remains to be elucidated whether or not interventions implemented after CI analysis, such as additional training for staff, electronic prescribing, or improvement in equipment, lead to increased patient safety in ICUs.