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

View Article: PubMed Central - PubMed

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.

No MeSH data available.


© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC5382851&req=5

Mentions: The schemes contained in CROQALM are designed to cover majority of analysis preformed in Croatian laboratories and are presented in Table 1. The control samples are distributed one to three times per year, depending on the participants’ application and the scheme schedule. In each scheduled exercise, one control sample per scheme (with instruction for sample preparation and measurement conditions) is sent to every laboratory requiring single measurement of analyte. Variable concentration levels are distributed that cover both normal and pathological ranges where available. At the end of each exercise, statistical evaluation of test results is done using inlab2*QALM software for quality evaluation in laboratory medicine (IN2 Group Ltd., Zagreb, Croatia), for each peer group consisting of seven or more participants. After outlier removal using Tukey model (1), mean, standard deviation and coefficient of variation is calculated for each peer group. The data are further evaluated according to predefined allowable limits of performance and z-scores with graphical presentation and main histogram for every analyte (Figure 1). Each laboratory receives report showing calculated percentage deviation of the result from corresponding peer group mean and z-score in absolute number showing positioning of the individual result regarding target value and standard deviation after outlier exclusion. Also, scheme coordinator comments performance characteristics for a given EQA exercise as a part of summary report. The annual report includes the Certificate of participation with an indication of the scheme in which they participated. The role of CROQALM is to implement and provide an assessment tool for laboratory performance, while the corrective actions upon ‘flagged’ results are responsibility of each individual laboratory. Evaluation of laboratory performance in Croatia is within the competence of CCMB and its professional supervision.


External Quality Assessment in Croatia: problems, challenges, and specific circumstances
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC5382851&req=5

Mentions: The schemes contained in CROQALM are designed to cover majority of analysis preformed in Croatian laboratories and are presented in Table 1. The control samples are distributed one to three times per year, depending on the participants’ application and the scheme schedule. In each scheduled exercise, one control sample per scheme (with instruction for sample preparation and measurement conditions) is sent to every laboratory requiring single measurement of analyte. Variable concentration levels are distributed that cover both normal and pathological ranges where available. At the end of each exercise, statistical evaluation of test results is done using inlab2*QALM software for quality evaluation in laboratory medicine (IN2 Group Ltd., Zagreb, Croatia), for each peer group consisting of seven or more participants. After outlier removal using Tukey model (1), mean, standard deviation and coefficient of variation is calculated for each peer group. The data are further evaluated according to predefined allowable limits of performance and z-scores with graphical presentation and main histogram for every analyte (Figure 1). Each laboratory receives report showing calculated percentage deviation of the result from corresponding peer group mean and z-score in absolute number showing positioning of the individual result regarding target value and standard deviation after outlier exclusion. Also, scheme coordinator comments performance characteristics for a given EQA exercise as a part of summary report. The annual report includes the Certificate of participation with an indication of the scheme in which they participated. The role of CROQALM is to implement and provide an assessment tool for laboratory performance, while the corrective actions upon ‘flagged’ results are responsibility of each individual laboratory. Evaluation of laboratory performance in Croatia is within the competence of CCMB and its professional supervision.

View Article: PubMed Central - PubMed

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.

No MeSH data available.