Transition to ISO 15189 : 2012 for Cytopathology Laboratories Part 4: Examination Processes and QC / QA System (QCAS)

Transition to ISO 15189 : 2012 for Cytopathology Laboratories Part 4: Examination Processes and QC / QA System (QCAS)

Eleftherios Vavoulidis (Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece), Stavros Archondakis (401 General Military Hospital of Athens, Athens, Greece), Maria Nasioutziki (Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece), Ourania Oustambasidou (401 General Military Hospital of Athens, Athens, Greece), Angelos Daniilidis (Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece), Konstantinos Dinas (Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece) and Aristotelis Loufopoulos (Medical School, Aristotle University of Thessaloniki and Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece)
Copyright: © 2016 |Pages: 21
DOI: 10.4018/IJRQEH.2016070104
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Abstract

Modern cytopathology laboratories offer an outstanding portfolio of testing services that are vital for patients. Due to their clinical importance, such laboratories have to provide results of high quality and credibility. Accreditation status and the implementation of a Quality Management System according to ISO15189 requirements are usually the most effective strategies to reach the optimum quality standards. However, laboratory quality should be constantly monitored and assessed in order to avoid potential deviations from the pre-defined values. The design of a unified system of Quality Control and Assurance procedures that will guarantee excellent performance and results is essential. The authors present their experience on the implementation of such a system and describe in detail strategies for efficient quality management. Useful recommendations for the design of such a system are provided. Finally, a mobile health application that could potentially enhance the entire quality control and assurance system is also presented.
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Introduction

Various definitions can be used to describe the term “quality”, especially when related to healthcare and medical services. Quality can be defined as the threshold below which the final provided product or service is insufficient or inadequate to satisfy the needs of the consumers. So, in terms of laboratory diagnostic medicine, quality is the group of characteristics and attributes that a specific diagnostic service or product should possess in order to satisfy the stated needs and the implied expectations of the referral doctors and patients (Burnett, 1999; Branca & Longatto-Filho, 2015).

Cytopathology laboratories offer diagnostic services that are crucial for patient care. First of all, the well-known Papanicolaou smear has been proved to a powerful and cost-effective screening tool for the early detection of malignant cells and various forms of dysplasia than can be observed in cervical samples taken from asymptomatic women. Furthermore, the integration of theoretical principles from other scientific fields such as molecular biology, genetic engineering, analytical chemistry and biochemistry and the introduction of liquid-based cytology (LBC) preparations into the field of Cytopathology have enriched modern diagnostic laboratory with an outstanding portfolio of testing evaluations that has been extended from the cell observation to the analysis of DNA and RNA molecules, genetic markers and proteins (Hidalgo et al., 2005; Ronco et al., 2007). All these cytopathology examinations, both morphological and molecular, include arrangements for examination requests, patient preparation and identification, collection, transportation, storage, processing and evaluation of clinical samples, together with subsequent interpretation, reporting and advice.

Due to the high clinical significance of their services and final reports, modern cytopathology laboratories need to develop and apply strategies ensuring that the quality of the laboratory performance and activities will always be adequate to satisfy the needs of the patient care while being suitable for its intended use. The most efficient way to achieve laboratory quality is though the design and implementation of a Quality Management System (QMS) that fulfills the requirements of the ISO 15189:2012 International Standard for medical laboratories and though obtaining of an accreditation status from a committee of external peer-reviewing experts (Klazinga, 2000; Alkhenizan & Shaw, 2010; Braithwaite et al., 2011). ISO 15189 is an ideal and well-designed combination of the quality system requirements of ISO 9001 with the competency requirements of ISO 17025 that focuses, among others, on critical pre-analytical, analytical and post-analytical processes that may affect the quality of the provided laboratory services while addressing the specific needs of diagnostic laboratories including the cytopathology ones (Burnett, 2013).

A modern diagnostic laboratory should not only aim to provide high quality services to its clients but also monitor constantly its performance and try to maintain or even enhance its quality standards. In other words, once laboratory quality is initially assessed, the laboratory should take all the necessary action and measures to ensure that the established quality values will be maintained at any given time. This is achieved mainly by Quality Control (QC) and Quality Assurance (QA) procedures that compose a well-structured Quality Control & Assurance System (QCAS) that a diagnostic laboratory should implement in its well-structured QMS. QC defines service’s quality, imparting to it the credibility needed for its intended purpose, while QA activities measure the degree to which desired outcomes are successful (Archondakis, 2015).

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