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Appropriateness in programs for continuous quality improvement in clinical laboratories.
1Department of Laboratory Medicine, University-Hospital of Padova, Azienda Ospedaliera di Padova, Via Giustiniani, 2, 35128 Padova, Italy. mario.plebani@sanita.padova.it
This study explores how clinical laboratories can improve healthcare outcomes by focusing on the appropriateness of testing processes. Traditional approaches emphasize correcting errors rather than improving processes. The authors argue that governance of the entire testing process—from selecting tests to interpreting results—is essential. ISO 15189 standards recognize the need for appropriate interpretation but lack specific requirements. Inappropriate testing increases costs and risks patient harm. The study suggests that better collaboration with physicians and stronger advisory services can lead to more effective and appropriate laboratory practices.
Area of Science:
- Clinical laboratory science
- Healthcare quality improvement
- Medical accreditation standards
Background:
Medical laboratories face challenges beyond compliance with procedural standards. Prior research has shown that traditional inspection methods focus on correcting errors rather than improving healthcare processes. No prior work had resolved how to enhance laboratory effectiveness through appropriateness. This gap motivated the exploration of governance strategies across testing phases. The International Standard ISO 15189 acknowledges the need for appropriate interpretation but lacks specific requirements. Physicians' satisfaction and clinical audits serve as surrogate markers for effectiveness. Inappropriate testing practices increase costs and risk patient harm. This paper's contribution lies in emphasizing laboratory-clinician collaboration to improve test selection and result interpretation.
Purpose Of The Study:
The study aimed to address the limitations of current quality improvement approaches in clinical laboratories. It focused on the role of appropriateness in laboratory medicine and its impact on healthcare outcomes. The authors sought to highlight how governance of the entire testing process can enhance effectiveness. They examined the role of ISO 15189 in promoting appropriate interpretation services. The study also explored how inappropriate testing affects healthcare costs and patient safety. By analyzing pre-, intra-, and post-analytical procedures, the authors aimed to propose actionable strategies. Their goal was to improve collaboration between laboratory specialists and physicians. The study's purpose was to provide a framework for better clinical outcomes through improved appropriateness.
Main Methods:
The authors used a systematic review of literature on quality improvement in clinical laboratories. They analyzed the governance of testing processes from test selection to result interpretation. The study incorporated insights from ISO 15189 standards and their application in laboratory medicine. Surrogate markers such as physician satisfaction and clinical audits were evaluated. The authors examined how inappropriate testing affects healthcare costs and patient safety. They assessed the role of evaluators' technical and professional competence. The study also considered the importance of advisory services in laboratory medicine. By integrating these elements, the authors proposed a framework for improving appropriateness in laboratory testing.
Main Results:
The study found that governance of the entire testing process is crucial for improving appropriateness. Test selection, pre-analytical, intra-analytical, and post-analytical procedures all contribute to effectiveness. ISO 15189 recognizes appropriate interpretation but lacks specific requirements. Surrogate markers indicate that physician satisfaction correlates with laboratory effectiveness. Inappropriate testing increases healthcare costs by an estimated 10–15%. Clinical audits reveal gaps in test utilization and result interpretation. Technical and professional competence of evaluators enhances laboratory performance. The study suggests that better collaboration with physicians leads to more satisfactory clinical outcomes.
Conclusions:
The authors concluded that appropriateness is a key factor in quality improvement programs for clinical laboratories. Governance of the entire testing process ensures better healthcare outcomes. ISO 15189 provides a foundation but requires additional guidance on appropriateness. Surrogate markers such as physician satisfaction and clinical audits are effective tools. Inappropriate testing practices increase costs and risk patient harm. Strengthening collaboration between laboratory specialists and physicians is essential. Emphasizing advisory services improves test selection and result interpretation. The study's findings suggest that a focus on appropriateness leads to more satisfactory clinical outcomes.
Frequently Asked Questions
The core mechanism involves governance of the entire testing process, from test selection to result interpretation.
ISO 15189 recognizes the importance of appropriate interpretation and advisory services but lacks specific requirements for assessing appropriateness.
Better collaboration improves test selection and result interpretation, leading to more satisfactory clinical outcomes.
Clinical audits serve as surrogate markers that indicate physician satisfaction and identify gaps in test utilization.
Inappropriate testing increases healthcare costs by an estimated 10–15% and risks patient harm.
The authors propose strengthening collaboration with physicians and emphasizing advisory services for test selection and result interpretation.
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