External quality assessment providers’ services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions

Abstract

Objectives Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated. Methods Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples. Results These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers’ support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates. Conclusions Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

Design of external quality assessment schemes and definition of the roles of their providers in future epidemics

“…Therefore, the applicable legal provisions state whether the laboratory can, or must, implement the identified need for action. 6 The benefits for laboratories participating in EQAs are the confidential evaluation of the analytical performance of their methods by a competent, independent third party, and the opportunity to compare their results with those obtained by other laboratories, assays, or procedures. In this way, the potential for improvement can first be identified, and opportunities for improvement, as compared with other participants, can then be considered.…”

“…Extra-EQA services of EQA providers were reported to have positively influenced the quality performance of laboratories, at least in immunohaematology. 6 Both EQA and extra-EQA services give their providers a unique position and relevance to the laboratory analysis community. Their services are especially needed during pandemics, when knowledge about the pathogen and pathogen diagnostics is initially low and then grows rapidly, and public health measures and recommendations for diagnostics are constantly adapting based on key epidemiological data.…”

Design of external quality assessment (EQA) schemes and definition of the roles of their providers in future epidemics

“…The importance of EQA schemes in post-market surveillance of in-vitro medical diagnostics down to the level of individual batches is evident [9]. Furthermore, all publications reported on the counts of test facilities enrolled (2), the rates of false positive and false negative results (5) and their relation to virus or RNA load in samples (6). The latter refers to the analytical sensitivity and this is essential when specifying the limit of detection on the laboratory report if the pathogen was not detected.…”

“…In addition to organizing and supervising interlaboratory comparisons, EQA providers are also a contact for medical/technical inquiries and serve as a network center that links test facilities, experts, and public health authorities. It was reported that extra-EQA services EQA providers positively in uence the quality performance of laboratories, at least in immunohaematology [6]. Moreover, EQA schemes not only function to evaluate the pro ciency of diagnostic laboratories, but also to harmonize testing across laboratories.…”

“…The relevant ISO 17043 standard generally uses the term "pro ciency test" for interlaboratory comparison, while the term "external quality assessment" is more common in the medical area [5]. There are major differences in national legislation on the obligation to participate in EQA, the monitoring of laboratory performance by authorities and the possible consequences of failure [6].…”