External Quality Assessment in Croatia: problems, challenges, and specific circumstances

Abstract

In Croatian medical laboratories (ML), external quality assessment (EQA) has a long tradition of almost half of a century. At national level, EQA is provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) which is a part of Croatian Society of Medical Biochemistry and Laboratory Medicine. This case study aimed to summarize the main challenges, which are set to CROQALM and their possible solutions. CROQALM has 10 schemes, covering majority of analysis for which medical biochemistry laboratories in Croatia are authorized for, including pre-analytical and post-analytical phase of laboratory work. Assessment scheme has three exercises per year. One sample per scheme and exercise is distributed to participants depending on their application. All data transfer and evaluation of the results are done using web interface and statistical software for evaluation of quality in laboratory medicine. Since CROQALM has relatively small number of participating laboratories (N = 197) with lot of different manufacturers of instruments used for analysis in all schemes, constant challenges are present in the evaluation of the results (commutability problems, statistical analysis etc.). Further, number of participating medical laboratories is even lower for highly specific parameters, which are in the scope of clinical laboratories only. Despite the obstacles we are faced to, EQA at national level is useful tool regarding standardization and harmonization aspects in total testing process within the country. Furthermore, it gives participating laboratories recognition and proof for meeting expected quality criteria in the community they serve.

Status of Quality Control for Laboratory Tests of Medical Institutions in Korea: Analysis of 10 Years of Data on External Quality Assessment Participation

“…The total quality change in each institution could, therefore, not be determined. Although EQA is widely used for monitoring the performance of clinical laboratories [6], EQA only measures performance quality at specific time points, which does not reflect the overall quality of laboratory performance. Participation in laboratory accreditation programs could be a good alternative for monitoring and improving the overall quality of laboratory testing.…”

“…EQA is widely used as a tool to monitor laboratory quality [6]. EQA assesses the analytical performance of a laboratory relative to its peers (laboratories using the same method or instrument), reference standards, and/or reference laboratories [7].…”

The New Diagnosis-Related Group Reimbursement System and Laboratory Test Quality in Korea: Analysis of External Quality Assessment Results

“…Further, EQA data may not be a sensitive enough indicator reflecting laboratory quality changes after the new payment system was introduced. Although EQA is widely used for monitoring medical laboratory performance [ 16 ], it reflects quality only at specific points in time, not the laboratory’s overall quality. Additionally, quality improvement in Korea has already reached a fairly high level, due to decades-long efforts in EQA participation.…”

“…The EQA results of the Korean Association of External Quality Assessment Service (KEQAS) database over three years (2016)(2017)(2018) were analyzed for clinical laboratories, which were included as study subjects. EQA is a widely accepted method for evaluating clinical laboratories and enhancing their performance [16]. KEQAS was launched in 1976 and is the nation's top authorized EQA provider for standardization and quality management of the laboratory tests of domestic hospitals.…”

Schemes and Performance Evaluation Criteria of Korean Association of External Quality Assessment (KEQAS) for Improving Laboratory Testing

“…A peer group usually consists of laboratories that use the same analyzer from the same manufacturer, as similar matrix-related bias for a given specimen can be assumed. The use of manufacturer-based peer groups is the only acceptable method for comparing the test results of multiple analytes in immunoassay, hematology, and molecular test schemes, which lack standardization and/or harmonization across participating laboratories that use similar principles but slightly different methodologies [ 12 ]. The peer groups are further divided into instrumentor reagent-based subgroups.…”