This Week’s Scientific Short was contributed by Dr. Mario Plebani, the 2014 AACC/NACB Award winner for Outstanding Contributions to Clinical Chemistry in a Selected Area of Research.
Quality in laboratory medicine should be defined as the guarantee that each and every step in the total testing process (TTP) is correctly performed, thus ensuring valuable decision making and effective patient care.
Do you agree or disagree with this definition?
A body of evidence has been accumulated to demonstrate that pre- and post-analytical phases are more vulnerable to errors than the analytical steps. The global view of quality in laboratory medicine calls for a change in the current paradigm which paces focus only on the testing process steps that are under the direct control of the clinical laboratory. The importance of the pre-pre-analytical phase (patient and sample identification, appropriateness in test request, blood drawing, sample handling and transportation) as well as of post-post-analytical phase (acknowledgment, interpretation and utilization of laboratory results) has been widely demonstrated. For a patient-centered approach, therefore, there is the need to assure that each and every step of the TTP is correctly performed, that eventual weaknesses should be recognized, and that corrective/preventive actions designed and implemented.
What are useful tools for measuring and improving the quality of the TTP?
According to the ISO 15189:2012 International Standard for clinical laboratory accreditation, quality indicators (QIs) are defined as “measure[s] of the degree to which a set of inherent characteristics fulfils requirements” and “can measure how well an organization meets the needs and requirements of users and the quality of all operational processes”. In 2004, The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) launched a project that promoted and developed a model of quality indicators (MQI) by implementing a Working Group on Laboratory Errors and Patient safety (WG LEPS). This model should be divided into process and outcome measures, mainly based on measures of the pre-, intra- and analytical procedures and processes. The model was revised by a 2013 Consensus Conference organized to establish a list of QIs that should be evidence-based, feasible, and actionable for most laboratories around the world. The list of QIs is available at www.ifcc-mqi.com. How has your laboratory improved quality throughout the total testing process?
Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, Ivanov A, Miller WG, Petinos P, Sciacovelli L, Shcolnik W, Simundic AM, Sumarac Z. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med. 2014;52(7):951-8.
Carraro P, Zago T, Plebani M. Exploring the initial steps of the testing process: frequency and nature of pre-preanalytic errors. Clin Chem. 2012;58:638-42.
Plebani M. Quality Indicators to Detect Pre-Analytical Errors in Laboratory Testing Clin Biochem Rev 2012; 33: 85-8
Sciacovelli L, O'Kane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, Ivanov A, Ghys T, Plebani M; IFCC WG-LEPS. Quality Indicators in Laboratory Medicine:from theory to practice. Preliminary data from the IFCC Working Group Project "Laboratory Errors and Patient Safety". Clin Chem Lab Med. 2011;49:835-44.