Performance criteria of the post-analytical phase

Abstract

Quality in healthcare is ideally at an optimal benchmark, but must be at least above the minimal standards for care. While laboratory quality is ideally judged in clinical terms, laboratory medicine has also used biological variations and state-of-the-art criteria when, as is often the case, clinical outcome studies or clinical consensus are not available. The post-analytical phase involves taking quality technical results and providing the means for clinical interpretation in the report. Reference intervals are commonly used as a basis for data interpretation; however, laboratories vary in the reference intervals they use, even when analysis is similar. Reference intervals may have greater clinical value if they are both optimised to account for physiological individuality, as well as if they are harmonised through professional consensus. Clinical decision limits are generally superior to reference intervals as a basis for interpretation because they address the specific clinical concern in any patient. As well as providing quality data and interpretation, the knowledge of laboratory experts can be used to provide targeted procedural knowledge in a patient report. Most profoundly critically abnormal results should to be acted upon to minimise the risk of mortality. The three steps in quality report interpretation, (i) describing the abnormal data, (ii) interpreting the clinical information within that data and (iii) providing knowledge for clinical follow-up, highlight that the quality of all laboratory testing is reflected in its impact on clinical management and improving patient outcomes.

Assuring the quality of interpretative comments in clinical chemistry

“…These scales are similar to 'Likert' scales often used to measure agreement between observers (5 -strongly agree, 4 -agree, 3 -neither agree nor disagree, 2 -disagree, 1 -strongly disagree) and have been applied in clinical medicine to compare with expert interpretations (e.g. in radiology and prescribing) [30]. Based on these precedents, we propose the following scale 5: -optimal, 4 -good, 3 -neutral, 2 -unsatisfactory, 1 -poor ( Table 2).…”

Patient Safety in Laboratory Medicine. The Big Picture ten years later

“…Ed erano [4] e sono [5] ben note le conseguenze sulla mis-classificazione diagnostica dei pazienti dell'inaccuratezza delle misure, in particolare in alcune aree (TDM, monitoraggio degli anticoagulanti, HbA 1c , test genetici). Tuttavia, il progresso tecnologico ha diffuso una convinzione di "certezza" della misura, che coinvolge clinici e laboratoristi, basata sulla perfezione tecnica dei device/strumenti e Linda Thienpont [6] si chiedeva chi avrebbe baciato la Bella Addormentata (l'accuratezza), sostituita molto spesso nell'automazione dalla ripetibilità e dalla semplificazione e nelle analisi decentrate dalla semplicità e dall'immediatezza.…”

External Quality Assessment beyond the analytical phase: an Australian perspective

“…Sikaris has identified the importance of the post-laboratory phase and how it is subject to error, such as the misapplication of appropriate and accurate test results through cognitive failure ( 12 ). Laboratory tests and their misinterpretation are still an important contributor to misdiagnosis because of the emphasis put on laboratory testing for diagnosis and monitoring decisions.…”

“…The results would be analysed and reported back with a guideline-based response, concordance, and group performance (see Appendix 1 for an example of such a report). Sikaris has described these concepts in terms of a medical laboratory, but they are translatable to a referring doctor model ( 12 ). The cases will need to be carefully chosen, however, so that the suggested interpretations in terms of what tests to order based on a given clinical scenario or what treatment to suggest has a strong evidence base in both current literature and current clinical guidelines.…”