Errors In Laboratory Medicine Research Articles

The IFCC Working Group on laboratory errors and patient safety

The increasing attention paid to patient safety, and the awareness that the information provided by clinical laboratories impacts directly on the treatment received by patients, has made it a priority for clinical laboratories to reduce their error rates and promote an excellent level of quality. The capacity for reporting, analysing and learning from experience is still seriously hampered by a lack of methodological uniformity in identification and measurement, inadequate reporting schemes for error events, the fear of professional liability, and weak information systems. In previous years, the use of quality indicators to assess and monitor the quality systems of clinical laboratories considerably benefited quality management. Yet currently there are no guidelines available for identifying and correcting development of quality indicators in laboratory medicine, although the International Standard ISO 15189:2007 for Accreditation of Medical Laboratory requires them to be implemented. The aim of this work was therefore to report on the project, nominated “Model of Quality Indicator”, undertaken by the Working Group, “Laboratory Errors and Patient Safety (WG-LEPS)” instituted by the division of Education and Management (EMD) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The mission of the WG-LEPS is to promote and encourage investigations into errors in laboratory medicine, collect data available on this issue and recommend strategies and procedures for improving patient safety.

Exploring the iceberg of errors in laboratory medicine

The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories, and currently available evidence demonstrates that the pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. In particular, most errors are identified in pre–pre-analytic and post–post analytic steps outside the walls of the laboratory, and beyond its control. However, in a patient-centered approach to the delivery of health care services, there is the need to investigate any possible defect in the total testing process that may have a negative impact on the patient. In fact, in the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error is caused by a laboratory professional (e.g., calibration or testing error) or by a non-laboratory operator (e.g., inappropriate test request, error in patient identification and/or blood collection). Data on diagnostic errors in primary care and in the emergency department setting demonstrate that inappropriate test requesting and incorrect interpretation account for a large percentage of total errors whatever the discipline involved, be it radiology, pathology or laboratory medicine. Patient misidentification and problems in communicating results, which affect the delivery of all diagnostic services, are widely recognized as the main goals for quality improvement. Therefore, some common problems affect diagnostic errors, although specific faults characterising errors in laboratory medicine should lead to preventive and corrective actions if evidence-based quality indicators are developed, implemented and monitored. The lesson we have learned is that each practice must examine its own total testing process to discover its weaknesses and identify appropriate remedies.

Preanalytical errors in primary healthcare: a questionnaire study of information search procedures, test request management and test tube labelling

Most errors in laboratory medicine occur in the preanalytical phase and are the result of human mistakes. This study investigated information search procedures, test request management and test tube labelling in primary healthcare compared to the same procedures amongst clinical laboratory staff. A questionnaire was completed by 317 venous blood sampling staff in 70 primary healthcare centres and in two clinical laboratories (response rate = 94%). Correct procedures were not always followed. Only 60% of the primary healthcare staff reported that they always sought information in the updated, online laboratory manual. Only 12% reported that they always labelled the test tubes prior to drawing blood samples. No major differences between primary healthcare centres and clinical laboratories were found, except for test tube labelling, whereby the laboratory staff reported better practices. Re-education and access to documented routines were not clearly associated with better practices. The preanalytical procedure in the surveyed primary healthcare centres was associated with a risk of errors which could affect patient safety. To improve patient safety in laboratory testing, all healthcare providers should survey their preanalytical procedures and improve the total testing process with a systems perspective.

Misidentification and Other Preanalytical Errors

Misidentification and Other Preanalytical Errors The largest number of laboratory errors occur in the preanalytical phase and are mainly due to educational and organizational reasons. The experience of our institution, as well as the results of an Italian interlaboratory effort to detect and reduce errors/risk of errors in laboratory medicine will be illustrated.

Preanalytical venous blood sampling practices demand improvement — A survey of test-request management, test-tube labelling and information search procedures

BackgroundMost errors in laboratory medicine are preanalytical in nature. In the present study, we aimed to survey preanalytical steps in venous blood sampling, prior to actual sample collection. These steps included test-request management and test-tube labelling, as well as information search procedures. MethodsVenous blood sampling staff (n=314, response rate 94%) in hospital wards and laboratories completed a questionnaire related to clinical chemistry testing. ResultsInstructions for test-request management and test-tube labelling were not always followed. For example, only 66% of the ward staff reported always checking the test-request if someone else completed it, compared to 90% of the laboratory staff (p=0.003). As few as 16% of the ward staff reported desirable practices regarding test-tube labelling, compared to 100% of the laboratory staff (p<0.001). Furthermore, 18% of the ward staff reported always using online manuals (the only source of updated information), compared to 63% of the laboratory staff (p<0.001). ConclusionsOur results indicate a substantial risk of preanalytical error in test-request management, test-tube labelling, and information search practices, particularly in the wards. Our findings thus underscore the importance of quality control in venous blood sampling, in order to increase patient safety in modern health care.

Errors in laboratory medicine and patient safety: the road ahead

The Institute of Medicine (IOM) report, To err is human, galvanized a dramatically increased level of concern about adverse events and patient safety in healthcare, including errors in laboratory medicine. While a significant decrease in the error rates of clinical laboratories has been achieved and documented in recent decades, available evidence demonstrates that the pre- and post-analytical phases of the total testing process are more vulnerable to errors than the analytical phase. However, analytical quality is still a major issue, particularly in some areas of laboratory medicine such as immunoassaying. In the present paper, current trends and factors that could effect future changes in the frequency and types of errors in laboratory services are analyzed and discussed. A more effective integration of automation and information technology could allow clinical laboratories to identify, control and decrease error rates in the total testing process, but interdepartmental cooperation and communication with clinicians and other stakeholders are essential to improving patient safety. Moreover, a fundamental shift in improving patient safety in laboratory medicine is to move from error reporting to risk management.

Errors in clinical laboratories or errors in laboratory medicine?

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes in pre- and post-examination steps must be minimized to guarantee the total quality of laboratory services.

Errors in Laboratory Medicine: Practical Lessons to Improve Patient Safety

Patient safety is influenced by the frequency and seriousness of errors that occur in the health care system. Error rates in laboratory practices are collected routinely for a variety of performance measures in all clinical pathology laboratories in the United States, but a list of critical performance measures has not yet been recommended. The most extensive databases describing error rates in pathology were developed and are maintained by the College of American Pathologists (CAP). These databases include the CAP's Q-Probes and Q-Tracks programs, which provide information on error rates from more than 130 interlaboratory studies. To define critical performance measures in laboratory medicine, describe error rates of these measures, and provide suggestions to decrease these errors, thereby ultimately improving patient safety. A review of experiences from Q-Probes and Q-Tracks studies supplemented with other studies cited in the literature. Q-Probes studies are carried out as time-limited studies lasting 1 to 4 months and have been conducted since 1989. In contrast, Q-Tracks investigations are ongoing studies performed on a yearly basis and have been conducted only since 1998. Participants from institutions throughout the world simultaneously conducted these studies according to specified scientific designs. The CAP has collected and summarized data for participants about these performance measures, including the significance of errors, the magnitude of error rates, tactics for error reduction, and willingness to implement each of these performance measures. A list of recommended performance measures, the frequency of errors when these performance measures were studied, and suggestions to improve patient safety by reducing these errors. Error rates for preanalytic and postanalytic performance measures were higher than for analytic measures. Eight performance measures were identified, including customer satisfaction, test turnaround times, patient identification, specimen acceptability, proficiency testing, critical value reporting, blood product wastage, and blood culture contamination. Error rate benchmarks for these performance measures were cited and recommendations for improving patient safety presented. Not only has each of the 8 performance measures proven practical, useful, and important for patient care, taken together, they also fulfill regulatory requirements. All laboratories should consider implementing these performance measures and standardizing their own scientific designs, data analysis, and error reduction strategies according to findings from these published studies.

Is it safe to have a laboratory test?

A recent US Institute of Medicine report indicated that up to 98,000 deaths and more than 1 million injuries occur each year in the United States due to medical errors. These include diagnostic errors, such as an “error or delay in diagnosis, failure to employ indicated tests” and the “use of outmoded tests.” Laboratory tests provide up to 80% of the information used by physicians to make important medical decisions, therefore it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. A review of the literature and a US Quality Institute Conference in 2003 indicates that errors in laboratory medicine occur most often in the pre-analytical and post-analytical steps in the testing process, but most of the quality improvement efforts focus on improving the analytical process. Measures must be developed and employed to reduce the potential for mistakes in laboratory medicine, including better indicators for the quality of laboratory service. Users of laboratory services must be linked with the laboratory’s information system to assist them with decisions about test ordering, patient preparation, and test interpretation. Quality assessment efforts need to be expanded beyond external quality assessment programs to encompass the detection of non-analytical mistakes and improving communication between the users of and providers of laboratory services. The actual number of mistakes in laboratory testing is not fully recognized, because no widespread process is in place to either determine how often mistakes occur or to systematically eliminate sources of error. We also tend to focus on mistakes that result in adverse events, not the near misses that cause no observable harm. The users of laboratory services must become aware of where testing mistakes can occur and actively participate in designing processes to prevent mistakes. Most importantly, healthcare institutions need to adopt a culture of safety, which is implemented at all levels of the organization. This includes establishing closer links between providers of laboratory services and others in the healthcare delivery system. This was the theme of a 2003 Quality Institute Conference aimed at “making the laboratory a key partner in patient safety.” Plans to create a permanent public–private partnership, called the Institute for Quality in Laboratory Medicine, whose mission is to promote improvements in the use of laboratory tests and laboratory services are underway.

Errors in Laboratory Medicine

The problem of medical errors has recently received a great deal of attention, which will probably increase. In this minireview, we focus on this issue in the fields of laboratory medicine and blood transfusion. We conducted several MEDLINE queries and searched the literature by hand. Searches were limited to the last 8 years to identify results that were not biased by obsolete technology. In addition, data on the frequency and type of preanalytical errors in our institution were collected. Our search revealed large heterogeneity in study designs and quality on this topic as well as relatively few available data and the lack of a shared definition of "laboratory error" (also referred to as "blunder", "mistake", "problem", or "defect"). Despite these limitations, there was considerable concordance on the distribution of errors throughout the laboratory working process: most occurred in the pre- or postanalytical phases, whereas a minority (13-32% according to the studies) occurred in the analytical portion. The reported frequency of errors was related to how they were identified: when a careful process analysis was performed, substantially more errors were discovered than when studies relied on complaints or report of near accidents. The large heterogeneity of literature on laboratory errors together with the prevalence of evidence that most errors occur in the preanalytical phase suggest the implementation of a more rigorous methodology for error detection and classification and the adoption of proper technologies for error reduction. Clinical audits should be used as a tool to detect errors caused by organizational problems outside the laboratory.