According to the International Standard for medical laboratories accreditation ISO 15189:2012, the laboratory should establish and periodically review quality indicators (QIs) to monitor and evaluate performance throughout critical aspects of pre-, intra and post-analytical processes. The use of QIs is needed to provide information and accountability to users and to establish a program of continuous improvement to ensure the quality of care and patient safety. In this context, we designed a QIs system as a part of a coherent and integrated quality improvement strategy. The management of QIs is based on an internal assessment system (IAS), which allows us to evaluate our performance over time and on the participation in an interlaboratory comparison managed as an EQA program, in order to compare our performance with other laboratories. The IAS includes a list of QIs, a form describing the specifications of each QI and a standard operating procedure. We participated in the project developed by the Working Group "Laboratory errors and patient safety" of IFCC on QIs. The project aims to identify a model of QIs that can be used worldwide through an EQA program. This paper aims to stimulate harmonization initiatives concerning QIs on the basis of the method and results of described experience.
Harmonization of quality indicators in Laboratory Medicine
Aita A.;Padoan A.;
2015
Abstract
According to the International Standard for medical laboratories accreditation ISO 15189:2012, the laboratory should establish and periodically review quality indicators (QIs) to monitor and evaluate performance throughout critical aspects of pre-, intra and post-analytical processes. The use of QIs is needed to provide information and accountability to users and to establish a program of continuous improvement to ensure the quality of care and patient safety. In this context, we designed a QIs system as a part of a coherent and integrated quality improvement strategy. The management of QIs is based on an internal assessment system (IAS), which allows us to evaluate our performance over time and on the participation in an interlaboratory comparison managed as an EQA program, in order to compare our performance with other laboratories. The IAS includes a list of QIs, a form describing the specifications of each QI and a standard operating procedure. We participated in the project developed by the Working Group "Laboratory errors and patient safety" of IFCC on QIs. The project aims to identify a model of QIs that can be used worldwide through an EQA program. This paper aims to stimulate harmonization initiatives concerning QIs on the basis of the method and results of described experience.
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