Towards harmonization of quality indicators in laboratory medicine

Abstract

The identification of reliable quality indicators (QIs) in the total testing process (TTP) represents a crucial step in enabling users to quantify the quality of laboratory services, but the current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence showing the multitude of errors that continue to occur in the pre-and post-analytical phases. Although interesting programs on indicators of the extra-analytical phases have been developed in some countries, there is no consensus on the production of joint recommendations for the adoption of universal QIs and the use of common terminology in the total testing process. In view of the different QIs and terminologies currently used, there an urgent need to harmonize proposed QIs, which should comply with three main principles: they must be patient-centered, consistent with the requirements of the International Standard for medical laboratories accreditation, and address all stages of the TTP. A model of quality indicators (MQI), consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Labo ratory Medicine (IFCC), includes 56 QIs related to key processes (34 pre-, 7 intra-and 15 postanalytical phase) and three to support processes. The scope of harmonization in laboratory medicine, more far-reaching than method harmonization, should cover a wider range of topics, namely all steps of the " brain-to-brain loop " . The identification of valuable QIs is a key step in paving the way towards quality and patient safety in laboratory medicine.

Harmonization of quality indicators in laboratory medicine. A preliminary consensus

“…It should be highlighted that the different steps required to develop and test QIs previously described [16][17][18] have been carefully followed.…”

“…While the identification of harmonized and universal QIs seems to be the "core" issue, standardization of systems for data collection and reporting represent critical steps towards effective harmonization initiatives [17]. After discussing a preliminary document, and answering to a series of related questions, all experts did agree to work on the revision of currently available QIs, starting from the already described IFCC MQI [15], taking into consideration the relevance of each QI, its generalizability and applicability by clinical laboratories from different countries.…”

The quality indicator paradox

“…The harmonization of QIs represents a fundamental step in achieving these goals, as only a list of harmonized QIs and a standardized reporting system will allow the inter-laboratory comparison of data and performances [9,10]. Based on these premises, the Working Group "Laboratory Errors and Patient Safety" (WG LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has developed a preliminary model of QIs (MQI) and a specific website (www.ifcc-mqi.com) in order to enable interested laboratories to undertake data collection [11,12].…”

Seven Q-Tracks Monitors of Laboratory Quality Drive General Performance Improvement: Experience From the College of American Pathologists Q-Tracks Program 1999–2011

“…Monitors resembling the 7 Q-Tracks monitors are among indices advocated by Plebani and others [38][39][40][41][42][43][44][45] as plausible quality indicators in laboratory medicine. All the Q-Tracks monitors assess defects that disrupt laboratory operations, as staff sort out order defects, investigate confused patient or specimen identifications, arrange recollection of specimens, respond to clinicians' complaints about median STAT TATs, field telephone calls about delayed STAT results, persist in attempting to report critical values, and correct results reported in error.…”