Naslov
The role of EQA in harmonization of reference intervals in Croatia

Autori
Flegar-Meštrić, Zlata ; Radišić Biljak, Vanja

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Izvornik
LABQUALITY DAYS, 5-6.2.2015, Helsinki, Finland / LABQUALITY, FINLAND - Helsinki : LABQUALITY, 2015, 22-22

Skup
LABQUALITY DAYS 2015

Mjesto i datum
Helsinki, Finska, 05.02.2015. - 06.02.2015

Vrsta sudjelovanja
Pozvano predavanje

Vrsta recenzije
Nije recenziran

Ključne riječi
harmonization; reference intervals

Sažetak
Introduction The main goal of medical laboratories is to be able to support the clinicians with the best achievable quality in all laboratory results and reports. Ongoing evaluation and improvement processes are essential to prove laboratory competence to provide performance in compliance with the highest professional standards having optimal health benefit for the patient. Participation in the external quality assessments schemes –EQA. are very often used for this purpose. EQA in Croatia Proficiency testing programs in Croatia have been continuously performed since 1973, by the Committee for External Quality Assessment, which in 2012 outgrow in the CROQALM – Croatian centre for quality assessment in laboratory medicine conducted by the Croatian Society for Medical Biochemistry and Laboratory Medicine as a non- profit, non- governmental organization dedicated to operate a nationwide quality assessment in laboratory medicine. EQA surveys are organized three times per year for more than 180 laboratories registered in the Croatian health care system, in the field of general medical biochemistry, laboratory haematology and coagulation, urinalysis, acid base status and ionized electrolytes, and from 2006 for thyroid hormones, tumour markers and glycated haemoglobin. Target values of laboratory test results are defined as mean target values of the group according to different methods (consensus value). For acceptability evaluation of test results, internationally accepted hierarchical approach to analytical quality goals which include metrological principles, biological variation, diagnostic needs and clinical usefulness is used. Harmonization of laboratory test results in Croatia In 2004, in order to harmonize laboratory test results, the Croatian Society of Medical Biochemists (Committee for External Quality Assessment of MBLs), Croatian Chamber of Medical Biochemists and Department of Clinical Chemistry and Laboratory Medicine University Hospital Merkur- Reference centre of the Ministry of Health for the production of reference values in the field of general medical biochemistry have started the project of harmonization of laboratory test results in the field of general medical biochemistry. The following parameters were included: general biochemical parameters (metabolites and substrates, enzymes, electrolytes, microelements, proteins), routine urine and stool analysis and laboratory haematology and coagulation. The main goals of this project were: to achieve analytical comparability of the results based on recommended analytical methods as well as to achieve the highest possible level of clinical comparability of the test results based on implementation of the unique reference intervals produced for the Croatian population. The basic prerequisite for the harmonization of laboratory test results was knowledge about methodology used in Croatian medical biochemistry laboratories. Therefore, the analysis of the current state in more than 180 Croatian medical biochemistry laboratories was performed. A review of long-term results collected on external quality assessment surveys has shown that almost 30% of laboratories achieved the analytical goals with 100% of acceptable results, more than 60% laboratories fulfilled the requirements with more than 80% of acceptable results, and less than 10% of the laboratories were not able to fulfil the required analytical quality specification. Applying unique recommended analytical methods and complying with established criteria for analytical quality of the results through national program of external quality assessment have created the conditions for the application of unique reference intervals depending on age and gender. Considering the fact that the results of laboratory tests are becoming useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. Variability of the clinically relevant blood constituents throughout an individual’s lifetime depends on various physiological processes and numerous biological factors which define characteristics of any population . Therefore the reference intervals for different biochemical serum constituents had been the subject of investigation of many laboratories, mostly throughout Western Europe and North America, for the last decades. The recommended reference intervals for the Croatian population were produced for 34 clinically relevant blood and serum constituents under strictly controlled conditions according to the IFCC recommendations on the representative reference sample group of 2246 adults and 998 children, age 8-70 years. All tests were performed by the Department of Clinical Chemistry and laboratory medicine, at the University Hospital “Merkur”, Zagreb, Croatia. For pediatric population, reference intervals were recommended according to the literature data. In the field of diabetology, there were some major activities regarding standardization and harmonization of HbA1c (in 2005. and 2011.), and implementation of new guidelines for diagnosis and management of gestational diabetes (in 2013.). In order to harmonize laboratory results the Croatian Chamber of Medical Biochemists recommended application of obtained reference intervals for all laboratories using the recommended analytical methods since January, 2005. Conclusion Based on the results of these ongoing long-term evaluation, the major benefits of EQA are to enhance patients care through improved analytical quality and working conditions in the medical biochemistry laboratories in Croatia ; to evaluate laboratory results across different methods and different reagents ; to identify medical- biochemical laboratories with poor performance and unacceptable results ; to evaluate possible sources of error ; to satisfy accreditation standard and regulatory requirements of Croatian Chamber of Medical Biochemists and Croatian Accreditation Agency. The obtained results show that proficiency testing programs in Croatia, have an important role in improving the quality of laboratory results enhancing their clinical efficiency and raising the quality of health care. The participation in the international EQA schemes is of the most importance as one of the main purposes of external quality assessment in medical-biochemical laboratories is to provide an independent and objective evaluation of laboratory test results at international level in order to promote global standardization/ harmonization of the whole laboratory process and achieve a high degree of interlaboratory comparability.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA