The detection and prevention of errors in laboratory medicine

Abstract

The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories. Evidence demonstrates that pre-and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. Most errors are identified in pre-pre-analytic and post-post-analytic steps outside of the laboratory. In a patientcentred approach to the delivery of health-care services, there is the need to investigate, in the TTP, any possible defect that may have a negative impact on the patient. 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 depends on a laboratory professional (e.g. calibration/testing error) or non-laboratory operator (e.g. inappropriate test request, error in patient identification and/or blood collection). Patient misidentification and problems communicating results, which affect the delivery of diagnostic services, are recognized as the main goals for quality improvement. International initiatives aim at improving these aspects. Grading laboratory errors on the basis of their seriousness should help identify priorities for quality improvement and encourage a focus on corrective/preventive actions. It is important to consider not only the actual patient harm sustained but also the potential worst-case outcome if such an error were to reoccur. The most important lessons we have learned are that system theory also applies to laboratory testing and that errors and injuries can be prevented by redesigning systems that render it difficult for all health-care professionals to make mistakes.

Harmonization in laboratory medicine: the complete picture

“…Fifth, while current evidence underlines the greater vulnerability of extra-analytical procedures and processes [ 2 ], greater awareness should be gained of the importance of standardization and harmonization initiatives aiming to reduce errors in the TTP and improve comparability of laboratory information. Standardization and harmonization go hand-in-hand since they are continuous processes that in synchronicity promote further standardization and harmonization efforts.…”

“…While a body of evidence gained in recent years demonstrates the decrease achieved in analytical errors, further efforts are required to address the vulnerability of pre-and post-analytical steps, and to assure comparability and concordance of data obtained by different clinical laboratories [ 2 ].…”

The quality indicator paradox

“…In laboratory medicine, the measurement of analytical quality through internal quality control and external quality assessment programmes has led to a significant improvement in accuracy in terms of both precision and trueness [2]. However, in the last few decades, a large body of evidence has demonstrated the high vulnerability of the pre-and post-analytical phases [3]. This finding depends on numerous factors, including the complexity of the processes entailed, limited automation and standardization, and the involvement of different health care operators at the interface between laboratories and clinical practices [4].…”

Harmonization in laboratory medicine: more than clinical chemistry?

“…The findings made in their survey paved the way for the development of external quality assurance (EQA)/proficiency testing (PT) programs and prompted efforts to establish the hierarchy of certified reference materials (CRMs) and reference measurement procedures (RPMs) that could be accepted as high-order references for the standardization of measurand results [9,10]. However, increasing consensus has been achieved on the need to focus on a global picture of harmonization, mainly in view of (a) the nature of errors in laboratory medicine [11]; (b) the evidence of large variations in terminology, units and reference intervals [12]; and (c) the risks for patient safety related to the above issues [1]. A body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases, and the need to promote quality and harmonization in each and every step of the testing cycle [1][2][3][4][5][6].…”