Preanalytical quality improvement: in quality we trust

Abstract

Total quality in laboratory medicine should be defined as the guarantee that each activity throughout the total testing process is correctly performed, providing valuable medical decision-making and effective patient care. In the past decades, a 10-fold reduction in the analytical error rate has been achieved thanks to improvements in both reliability and standardization of analytical techniques, reagents, and instrumentation. Notable advances in information technology, quality control and quality assurance methods have also assured a valuable contribution for reducing diagnostic errors. Nevertheless, several lines of evidence still suggest that most errors in laboratory diagnostics fall outside the analytical phase, and the pre-and postanalytical steps have been found to be much more vulnerable. This collective paper, which is the logical continuum of the former already published in this journal 2 years ago, provides additional contribution to risk management in the preanalytical phase and is a synopsis of the lectures of the 2nd European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled " Preanalytical quality improvement: in quality we trust " (Zagreb, Croatia, 1 -2 March 2013). The leading topics that will be discussed include quality indicators for preanalytical phase, phlebotomy practices for collection of blood gas analysis and pediatric samples, lipemia and blood collection tube interferences, preanalytical requirements of urinalysis, molecular biology hemostasis and platelet testing, as well as indications on best practices for safe blood collection. Auditing of the preanalytical phase by ISO assessors and external quality assessment for preanalytical phase are also discussed.

Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)

“…The median number of audits per country was 33 (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36). The total number of audits was 336.…”

“…Identification errors along with the proper diet restriction assessment and failure to allow patients to rest prior to phlebotomy were the most frequent errors observed in one recent cross-sectional comparative study performed in three government hospitals in South Ethiopia from February 2012 to September 2012 [33]. Improving patient identification by reducing the frequency of errors is therefore an ongoing challenge in all types of blood collection procedures and also a critical issue in other healthcare areas [34].…”

The quality indicator paradox

“…An account of the consensus achieved in the Conference on the characteristics of harmonized QIs, and on the standardized system of data collection and reporting has been given [13]. The list of harmonized QIs and information on a dedicated website designed to explain the rationale of the MQI project and enable clinical laboratories to collect data and to compare individual performances with all participating laboratories (benchmark) have been made available thanks to participation in national and international scientific meetings, issuing of documents through the International Federations and national societies, and publications in scientific journals [14][15][16][17][18][19][20]. The collection of data received by clinical laboratories participating in the MQI programme on the list of harmonized QIs has recently led to the definition of preliminary performance specifications in the pre-analytical phases [21].…”

Patient identification and tube labelling – a call for harmonisation

“…Although the prevalence of adverse events due to identification errors can be as high as 6%, more than 70% of them may result in significant patient inconvenience, with unknown change in treatment or outcome [14]. Therefore, the improvement of patient identification by decreasing the frequency of errors is a continuing challenge in all types of blood collection procedures and a crucial topic in many healthcare disciplines [15].…”