engleski

Quality in laboratory diagnostics: from theory to practice

While several areas of healthcare are still strug­gling with the issue of patient safety, diagnostics has been forerunner in pursuing this issue, so that the concept and practice of Total Quality Management (TQM) has now become commonplace throughout radiology, pathology and laboratory medicine. This does not mean, however, that the various branches of diagnostics are completely free from errors. In radiology, the level of error varies depending on the type of the investigation, but the range is 2–20% for clinically significant or major errors. At the practice level of pathology, the error rate is comprised between 13 and 14%. In the filed of laboratory medicine, the error rate ranges widely, from 0.1 to 3.0% of laboratory results. Since these extreme limits do not probably mirror closely the reality, a more probable error rate is that ranging from 0.3 to 0.6%. Of these errors, three-fourth generate ‘‘normal’’ results, one-sixth produce “absurd” results (which would be thereby identified before translating into a real harm for the patient), but approximately one-sixth might be so significant to have an adverse impact on patient care. Due to both an increasing consciousness of this important problem and a pervasive policy of education, the laboratory error rate has undergone a further reduction during the past 10 years (e.g., from 0.47% in 1997 to 0.33% in 2007), a trend particularly accentuated for analytical errors, so that the analytical variability is now frequently less than 1/20th of what it was 40 years ago.

errors; laboratory diagnostics; patient safety; preanalytical phase; quality

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