Systems for reporting adverse events can reduce medical errors by uncovering remediable problems in processes of care; however, current reporting systems are neither widely used nor highly effective. Reporting systems work best when they are confidential and easy to use, provide expert analysis of reports, and give timely feedback.

Reporting of adverse events.

Bile duct injuries are the main serious technical complication of laparoscopic cholecystectomy. 1,2 Data are insufficient to determine precisely the frequency of bile duct injuries, but a reasonable estimate is one in 1,000 cases. 2 A decade ago, as the technique of laparoscopic cholecystectomy was first being learned by otherwise fully trained, practicing surgeons, the injury rate was noted to be greater during an individual’s first dozen cases than in subsequent ones. 2 This learning curve contribution is now much less important, for surgical residents learn the procedure under direct supervision of more experienced surgeons.

Surgeons have always analyzed their technical complications for insights that might be translated into improved performance. In the past the information available from such reviews could rarely go much beyond a tabulation of results. An understanding of the root causes of technical complications remained elusive. This report takes analysis of technical complications to greater depths, for it integrates the findings of videotapes of operations involving bile duct injuries, operative notes dictated after the operation had been completed but before an injury had become apparent, and conceptual tools of human factors research and the cognitive science of human error.

Causes and Prevention of Laparoscopic Bile Duct Injuries: Analysis of 252 Cases From a Human Factors and Cognitive Psychology Perspective

Causes of prescribing errors in hospital inpatients: a prospective study

Background: This study describes a nationwide survey that estimates the number and characteristics of anesthesia-related deaths for the year 1999. Methods: Death certificates from the French national mortality database were selected from the International Classification of Diseases, Ninth Revision codes using a variable sampling fraction. Medical certifiers were sent a questionnaire (response rate, 97%), and the anesthesiologist in charge was offered a peer review (acceptance rate, 97%). Files were reviewed to determine the mechanism of each perioperative death and its relation to anesthesia. Mortality rates were calculated using the number of anesthetic procedures estimated from a national 1996 survey and compared with a previous (1978‐1982) nationwide study. Results: Among the 4,200 certificates analyzed, 256 led to a detailed evaluation. The death rates totally or partially related to anesthesia for 1999 were 0.69 in 100,000 (95% confidence interval, 0.22‐1.2 in 100,000) and 4.7 in 100,000 (3.1‐6.3 in 100,000), respectively. The death rate increased from 0.4 to 55 in 100,000 for American Society of Anesthesiologists physical status I and IV patients, respectively. Rates increased with increasing age. Although concerns regarding aspiration of gastric contents remain, intraoperative hypotension and anemia associated with postoperative ischemic complications were the associated factors most often encountered. Deviations from standard practice and organizational failure were often found to be associated with death. Conclusion: In comparison with data from a previous nationwide study (1978‐1982), the anesthesia-related mortality rate in France seems to be reduced 10-fold in 1999. Much remains to be done to improve compliance of physicians to standard practice and to improve the anesthetic system process.

Survey of anesthesia-related mortality in France

bated, and the task force chairman modified the document until <10% of the experts disagreed with the recommendations. Conclusions: An organized approach to the hemodynamic support of sepsis was formulated. The fundamental principle is that clinicians using hemodynamic therapies should define specific goals and end points, titrate therapies to those end points, and evaluate the results of their interventions on an ongoing basis by monitoring a combination of variables of global and regional perfusion. Using this approach, specific recommendations for fluid resuscitation, vasopressor therapy, and inotropic therapy of septic in adult patients were promulgated. (Crit Care Med 2004; 32:1928 ‐1948)

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Practice parameters for hemodynamic support of sepsis in adult patients: 2004 update.

Why do things go wrong? Human error is routinely blamed for disasters in the air, on the railways, in complex surgery, and in health care generally However, quick judgments and routine assignment of blame obscure a more complex truth The identification of an obvious departure from good practice is usually only the first step of an investigation Although a particular action or omission may be the immediate cause of an incident, closer analysis usually reveals a series of events and departures from safe practice, each influenced by the working environment and the wider organisational context This more complex picture is gaining acceptance in health care, 1 2 but it is seldom put into practice in the investigation of actual incidents

#### Summary points

Analyses of clinical incidents should focus less on individuals and more on organisational factors

Use of a formal protocol ensures a systematic, comprehensive, and efficient investigation

The protocol reduces the chance of simplistic explanations and routine assignment of blame

Experience with the protocol suggests that training is needed for it to be used effectively

Analysis of incidents is a powerful method of learning about healthcare organisations

Organisational analyses lead directly to strategies for enhancing patient safety

The Clinical Risk Unit has developed a process of investigation and analysis of adverse events for use by researchers3–7 Two years ago a collaborative research group was formed between the unit and members of the Association of Litigation and Risk Management (ALARM) This group has adapted the research methods to produce a protocol for the investigation and analysis of serious incidents for use by risk managers and others trained in incident analysis The protocol gives a detailed account of the theoretical background and process of investigation and analysis together with case examples8 In this article we introduce the main ideas …

How to investigate and analyse clinical incidents: Clinical Risk Unit and Association of Litigation and Risk Management protocol

Background: Over the past five years, in most hospitals in England and Wales, incident reporting has become well established but it remains unclear how well reports match clinical adverse events. International epidemiological studies of adverse events are based on retrospective, multi-hospital case record review. In this paper the authors describe the use of incident reporting, pharmacist surveillance and local real-time record review for the recognition of clinical risks associated with hospital inpatient care.

Methodology: Data on adverse events were collected prospectively on 288 patients discharged from adult acute medical and surgical units in an NHS district general hospital using incident reports, active surveillance of prescription charts by pharmacists and record review at time of discharge.

Results: Record review detected 26 adverse events (AEs) and 40 potential adverse events (PAEs) occurring during the index admission. In contrast, in the same patient group, incident reporting detected 11 PAEs and no AEs. Pharmacy surveillance found 10 medication errors all of which were PAEs. There was little overlap in the nature of events detected by the three methods.

Conclusion: The findings suggest that incident reporting does not provide an adequate assessment of clinical adverse events and that this method needs to be supplemented with other more systematic forms of data collection. Structured record review, carried out by clinicians, provides an important component of an integrated approach to identifying risk in the context of developing a safety and quality improvement programme.

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Hospital staff should use more than one method to detect adverse events and potential adverse events: incident reporting, pharmacist surveillance and local real-time record review may all have a place

Objective: To assess the utility of data already existing within hospitals for monitoring patient safety

Setting: An acute hospital in southern England

Design: Mapping of data sources proposed by staff as potentially able to identify patient safety issues followed by an in-depth analysis of the content of seven key sources

Data source analysis: For each data source: scope and depth of content in relation to patient safety, number and type of patient safety incidents identified, degree of overlap with incidents identified by different sources, levels of patient harm associated with incidents

Results: A wide range of data sources existing within the hospital setting have the potential to provide information about patient safety incidents Poor quality of coding, delays in reports reaching databases, the narrow focus of some data sources, limited data-collection periods and lack of central collation of findings were some of the barriers to making the best use of routine data sources for monitoring patient safety An in-depth analysis of seven key data sources (Clinical Incident database, Health and Safety Incident database, Complaints database, Claims database and Inquest database, the Patient Administration System and case notes) indicated that case notes have the potential to identify the largest number of incidents and provide the richest source of information on such incidents The seven data sources identified different types of incidents with differing levels of patient harm There was little overlap between the incidents identified by different sources

Conclusion: Despite issues related to the quality of coding, depth of information available and accessibility, triangulating information from more than one source can identify a broader range of incidents and provide additional information related to professional groups involved, types of patients affected and important contributory factors Such an approach can provide a focus for further work and ultimately contributes to the identification of appropriate interventions that improve patient safety

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E J Chapman

Papers

How to investigate and analyse clinical incidents: Clinical Risk Unit and Association of Litigation and Risk Management protocol

Hospital staff should use more than one method to detect adverse events and potential adverse events: incident reporting, pharmacist surveillance and local real-time record review may all have a place

What can we learn about patient safety from information sources within an acute hospital: a step on the ladder of integrated risk management?

[How to investigate and analyze clinical incidents: a clinical risk protocol in association with litigation and risk management].