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      The preanalytical phase – from an instrument-centred to a patient-centred laboratory medicine

      1 , 2
      Clinical Chemistry and Laboratory Medicine (CCLM)
      Walter de Gruyter GmbH

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          Abstract

          In order to guarantee patient safety, medical laboratories around the world strive to provide highest quality in the shortest amount of time. A major leap in quality improvement was achieved by aiming to avoid preanalytical errors within the total testing process. Although these errors were first described in the 1970s, it took additional years/decades for large-scale efforts, aiming to improve preanalytical quality by standardisation and/or harmonisation. Initially these initiatives were mostly on the local or national level. Aiming to fill this void, in 2011 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group “Preanalytical Phase” (WG-PRE) was founded. In the 11 years of its existence this group was able to provide several recommendations on various preanalytical topics. One major achievement of the WG-PRE was the development of an European consensus guideline on venous blood collection. In recent years the definition of the preanalytical phase has been extended, including laboratory test selection, thereby opening a huge field for improvement, by implementing strategies to overcome misuse of laboratory testing, ideally with the support of artificial intelligence models. In this narrative review, we discuss important aspects and milestones in the endeavour of preanalytical process improvement, which would not have been possible without the support of the Clinical Chemistry and Laboratory Medicine ( CCLM) journal, which was one of the first scientific journals recognising the importance of the preanalytical phase and its impact on laboratory testing quality and ultimately patient safety.

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          Most cited references56

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          Medical error—the third leading cause of death in the US

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            The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis

            Background Laboratory testing is the single highest-volume medical activity and drives clinical decision-making across medicine. However, the overall landscape of inappropriate testing, which is thought to be dominated by repeat testing, is unclear. Systematic differences in initial vs. repeat testing, measurement criteria, and other factors would suggest new priorities for improving laboratory testing. Methods A multi-database systematic review was performed on published studies from 1997–2012 using strict inclusion and exclusion criteria. Over- vs. underutilization, initial vs. repeat testing, low- vs. high-volume testing, subjective vs. objective appropriateness criteria, and restrictive vs. permissive appropriateness criteria, among other factors, were assessed. Results Overall mean rates of over- and underutilization were 20.6% (95% CI 16.2–24.9%) and 44.8% (95% CI 33.8–55.8%). Overutilization during initial testing (43.9%; 95% CI 35.4–52.5%) was six times higher than during repeat testing (7.4%; 95% CI 2.5–12.3%; P for stratum difference <0.001). Overutilization of low-volume tests (32.2%; 95% CI 25.0–39.4%) was three times that of high-volume tests (10.2%; 95% CI 2.6–17.7%; P<0.001). Overutilization measured according to restrictive criteria (44.2%; 95% CI 36.8–51.6%) was three times higher than for permissive criteria (12.0%; 95% CI 8.0–16.0%; P<0.001). Overutilization measured using subjective criteria (29.0%; 95% CI 21.9–36.1%) was nearly twice as high as for objective criteria (16.1%; 95% CI 11.0–21.2%; P = 0.004). Together, these factors explained over half (54%) of the overall variability in overutilization. There were no statistically significant differences between studies from the United States vs. elsewhere (P = 0.38) or among chemistry, hematology, microbiology, and molecular tests (P = 0.05–0.65) and no robust statistically significant trends over time. Conclusions The landscape of overutilization varies systematically by clinical setting (initial vs. repeat), test volume, and measurement criteria. Underutilization is also widespread, but understudied. Expanding the current focus on reducing repeat testing to include ordering the right test during initial evaluation may lead to fewer errors and better care.
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              Errors in a stat laboratory: types and frequencies 10 years later.

              In view of increasing attention focused on patient safety and the need to reduce laboratory errors, it is important that clinical laboratories collect statistics on error occurrence rates over the whole testing cycle, including pre-, intra-, and postanalytical phases. The present study was conducted in 2006 according to the design we previously used in 1996 to monitor the error rates for laboratory testing in 4 different departments (internal medicine, nephrology, surgery, and intensive care). For 3 months, physicians and nurses were asked to pay careful attention to all test results. Any suspected laboratory error was recorded with associated pertinent clinical information. Every day, a laboratory physician visited the 4 departments and a critical appraisal was made of any suspect results. Among a total of 51 746 analyses, clinicians notified us of 393 questionable findings, 160 of which were confirmed as laboratory errors. The overall frequency of errors, 3092 ppm, was significantly lower (P <0.05) than in 1996 (4700 ppm). Of the 160 confirmed errors, 61.9% were preanalytical errors, 15% were analytical, and 23.1% were postanalytical. During the last decade the error rates in our stat laboratory have been reduced significantly. As demonstrated by the distribution pattern, the pre- and postanalytical steps still have the highest error prevalences, but changes have occurred in the types and frequencies of errors in these phases of testing.
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                Author and article information

                Contributors
                (View ORCID Profile)
                (View ORCID Profile)
                Journal
                Clinical Chemistry and Laboratory Medicine (CCLM)
                Walter de Gruyter GmbH
                1434-6621
                1437-4331
                April 25 2023
                October 27 2022
                April 01 2023
                April 25 2023
                November 04 2022
                April 01 2023
                : 61
                : 5
                : 732-740
                Affiliations
                [1 ]Department of Laboratory Medicine , Paracelsus Medical University Salzburg , Salzburg , Austria
                [2 ]Department of Medical Laboratory Diagnostics , University Hospital “Sveti Duh”, University of Zagreb, Faculty of Pharmacy and Biochemistry , Zagreb , Croatia
                Article
                10.1515/cclm-2022-1036
                36330758
                5229f23e-c4a0-48ff-b0e6-1e1d53245299
                © 2023
                History

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