EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories

Abstract

The selection or procurement of blood collection devices in healthcare facilities is often an underestimated issue. This is probably due to different factors including the lack of knowledge of policymakers, hospital administrators and even laboratory managers about the importance of preanalytical quality and phlebotomy process, as well as to the absence of reliable guidelines or recommendations on how to precisely assess the quality of blood collection devices around the globe. With the awareness that a gap remains between manufacturers' and local validation of blood collection devices, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has drafted a consensus document aimed to provide a set of essential requisites, technical criteria (e.g. presence of physical defects, malfunctioning, safety problems) and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. The laboratory professionals should also make sure that the tenders accurately and strictly define the responsibilities for validation experiments and the potential consequences in the case the validation outcome shows that tubes due not fulfill the expectations.

Preanalytical Nonconformity Management Regarding Primary Tube Mixing in Brazil

“…Moreover, as regards the ISO 15189 standard, independent verification by the laboratory should confirm, using objective evidence (in the form of performance characteristics), that the performance claims for the pre-examination procedure (i.e. primary blood tubes mix) have a real influence on the quality of the total testing process, discounting any additional activity that will not generate a substantial impact on the reliability of laboratory test results (14–16). Evacuated blood tube mixing probably belongs to one of these latter activities.…”

Abnormal gel flotation caused by contrast media during adrenal vein sampling

“…tube manufacturer) to confirm the performance characteristics of the device/procedure. In addition, the independent verification by the laboratory should confirm, through objective evidence (in the form of performance characteristics), that the performance claims for the examination procedure have been met ( 7 , 8 ). The performance claims for the examination procedure, as confirmed during the verification process, shall be those relevant to the intended use of the examination results.…”

“…Moreover, selection and procurement of tubes for blood collection (i.e., tubes used during AVS procedure) in healthcare facilities is often an underestimated issue. Furthermore, national, regional and local tenders are frequently plagued by policies, guided primarily by price savings rather than by quality of tubes for blood collection ( 7 , 8 ). All devices (i.e., tubes for blood collection) should be standardized and managed by the laboratory in order to avoid different brands from the same kind of tubes at hospital.…”

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

“…Hence, the role of laboratories in evaluating medical devices will be strongly emphasized, also entailing the generation of documents supporting the quality of devices and proposing supplies of different devices. This practice is essential at a local level, but the role of preanalytical phase experts will also be important for defining and evaluating the general characteristics of devices and/or procedures [10]. Notably, the use of health technology assessment (HTA) for evaluating new technologies and devices is universally appreciated by national/regional healthcare systems, but will increasingly be used in the field of in vitro diagnostic testing [20].…”

“…In keeping with these issues, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has established a specific Working Group for the Preanalytical Phase (WG-PRE), the aims of which are mainly aimed at mitigating the vulnerability of many preanalytical activities, releasing official documents, guidelines and recommendations, as well as providing continuous education for laboratory professionals and other healthcare operators. The WG has already published many documents on the harmonization and/or standardization of preanalytical activities [6][7][8][9][10][11][12][13], and has also been proactive in organizing many educational meetings across Europe. This collective article hence follows the previous three opinion papers that were published by the EFLM WG-PRE on the same topic, in concert with the first [14], second [15] and third [16] join EFLM-BD meetings which were held in Parma, Zagreb and Porto.…”