Novel Opportunities for Improving the Quality of Preanalytical Phase. A Glimpse to the Future?

Abstract

SummaryThe preanalytical phase is crucial for assuring the quality of in vitro diagnostics. The leading aspects which contribute to enhance the vulnerability of this part of the total testing process include the lack of standardization of different practices for collecting, managing, transporting and processing biological specimens, the insufficient compliance with available guidelines and the still considerable number of preventable human errors. As in heavy industry, road traffic and aeronautics, technological advancement holds great promise for decreasing the risk of medical and diagnostic errors, thus including those occurring in the extra-analytical phases of the total testing process. The aim of this article is to discuss some potentially useful technological advances, which are not yet routine practice, but may be especially suited for improving the quality of the preanalytical phase in the future. These are mainly represented by introduction of needlewielding robotic phlebotomy devices, active blood tubes, drones for biological samples transportation, innovative approaches for detecting spurious hemolysis and preanalytical errors recording software products.

Uncertainty of Measurement in Laboratory Medicine

“…Literary data defines three levels of analytical goal for imprecision and analytical bias (17,(23)(24)(25). In order to evaluate the characteristics of analytical procedures in the laboratory, in addition to calculating imprecision and bias, biological variability data can be used to calculate the sigma metric, which can predict for which tests it will be necessary to implement a minimum quality control (26).…”

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

“…[14][15][16] Such studies should also ensure that well-established chain-of-custody, sample handling, and sample storage procedures are in place to maintain the quality of these valuable specimens. 17,18 A significant drawback of this approach is that often the samples may not have adequate characterization, may be of limited volume, and are proprietary to the study sponsors. It should also be taken into account that local laws or culture may be prohibitive to allowing specimens to be stored for future testing.…”

“…Ensuring proper sample storage and shipping conditions, processing and aliquotting (with attention to contamination control), training of site and clinical research organization lab personnel, a clear chain of custody from collection to final application, intermediate quality control checks, and good data management is critical for collection of high quality samples that can be used in the future. 17,26,27…”

“…Biological assay standardization is critical. 2,10,17,71,72 At a minimum, the development of relevant biological assays with adequate sensitivity and specificity for the application should use biostatistics to establish and verify assay performance and to maintain the ability to produce stable and reproducible results over time to support diagnostic or vaccine program needs. The criteria for acceptability of any given test system will be dependent upon the nature of the pathogen, our understanding of the immunology to fight the pathogen (both of which may be poorly understood in an EID situation) and the assay platform.…”

Project management in laboratory medicine

“…Regard less of personal inclinations and interests, »spoke« laboratories will generally need to be equipped with basic (first-line) laboratory tests, whereas »hub« laboratories will require more complex, time-consuming and expensive (second- and third-line) analyses. As previously discussed, decisions on the final organization of laboratory diagnostics within a network of laboratory services shall be taken in accordance with clinicians and hospital administrators, thus fulfilling clinical needs (12), principles of cost-effectiveness (13) and preanalytical requirements (14). Dissipating both human and economic resources for performing obsolete, redundant, clinically questionable or potentially unreliable analyses would not be beneficial for the healthcare system as a whole.…”