Abstract
Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.
Highlights
Numerous studies have been designed and conducted in the attempt to reduce the medical error rate; yet this issue still attracts public attention
The aim of the present paper is to describe and propose a new road map for the harmonization of quality indicators (QIs) in the pre-analytical phase
On preparing the Consensus Conference on “Harmonization of quality indicators in laboratory medicine: why, how and when?” [29], agreement has been achieved on the: a) value of QIs as an essential tool for accreditation and quality improvement in laboratory medicine, as well as their role in benchmarking and external quality assurance programs; b) need for QIs to comply with the above-described fundamental criteria; c) value of the IFCC Model of Quality Indicators (MQI) as a starting point for discussing and finalizing a consensual proposal on QIs. In this context the future goals of the WG-LEPS concerning QIs could focus on promotion and divulgation of a set of consensually approved QIs, as well as on the collection of data from international laboratories in order to define the state of the art of laboratory errors, share the more appropriate corrective actions to be implemented and monitor the improvement achieved
Summary
Numerous studies have been designed and conducted in the attempt to reduce the medical error rate; yet this issue still attracts public attention. In the definition of the pre-analytical phase made by the ISO 15189:2012, it is clearly recognized that there is a need to evaluate, monitor and improve all the procedures and processes in the initial phase of the TTP - the so-called “pre-pre-analytical phase”-, including test requesting, patient and sample identification, blood collection and sample handling and transportation. These procedures, which usually are neither performed in the clinical laboratory nor entirely fall under the control of laboratory personnel, are evaluated and monitored unsatisfactorily, often because the process owner is unidentified and the responsibility lies outside the boundary between the laboratories and clinical departments [3]. Unlabeled samples Mislabeled samples Insufficiently labeled samples Samples suspected of being from the wrong patient (“wrong blood in tube”) Irregularities in transfusion labeling requirements (e.g. signature of phlebotomist)
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