Daria Pašalić
Department of Medical Chemistry, Biochemistry and Clinical Chemistry
Zagreb University School of Medicine
Šalata ul 2.
10 000 Zagreb, Croatia
Phone +385 (1) 4590 205; +385 (1) 4566 940
E-mail: dariapasalic [at] gmail [dot] com

Useful links



Harmonization in the preanalytical phase

Ana-Maria Šimundić. Harmonization in the preanalytical phase. Biochemia Medica 2015;25(Suppl 1):S21-S22.

University Department of Chemistry, University Hospital Centre Sestre milosrdnice, Zagreb, Croatia


Harmonization encompasses all efforts made in a search for differences in policies and procedures and minimizing these. Since it reduces variability and errors, harmonization certainly leads to the quality improvement in every system. During the 3rd EFLM-BD European Conference on Preanalytical Phase held during 20 – 21 March in Porto (Portugal), representatives of many member societies of European federation for Clinical Chemistry and Laboratory Medicine (EFLM) have agreed that harmonization is necessary and possible at national as well as at international level and have expressed their willingness to work together with EFLM to work towards this goal. The way forward this goal is long and challenging. Which are the prerequisites for success?

The existence of standards is a major prerequisite in order to reach harmonization. Standards need to be evidence-based and focused to the benefit of the patient. Implementing these standards into the preanalytical phase is the next step. Each step of the preanalytical phase should be standardized, from test requesting, test ordering, patient preparation, patient identification, sampling, sample handling, storage and delivery to the laboratory. Do we have preanalytical phase standards? Unfortunately, standards for many of the preanalytical steps do not exist. Our major task for the future is, therefore, to define as many standards as possible. This achievable only if we fully understand and know all potential sources of variability within every preanalytical segment of the total testing process. Furthermore, the effects of these sources of variability on the sample quality, test results, patient outcome and financial outcome should also be known and understood. For those steps for which standards are already there, implementation of the standard is the next step. Successful implementation of the standard is a real challenge since it requires that all who are involved have a deep appreciation of the importance of the standardization of the respective preanalytical step. The compliance and cooperation is achieved through education of all stakeholders, starting from ourselves. Our stakeholders are medical doctors, nurses, laboratory technicians and patients. The education and quality management of preanalytical phase is our responsibility which has been defined in the ISO 15189 standard for medical laboratories.

This lecture shall provide an overview of the level of standardization and harmonization of preanalytical phase and point to the way forward by identifying some major challenges for the future.

The initiative for preanalytical harmonization needs to be established at many levels: at the level of international organizations, at national level (i.e. at the level of each national society for laboratory medicine), at the level of each laboratory and finally at individual level of each specialist of laboratory medicine. Each one of us need to make our own contribution. We need to work together in order to achieve consensus. This is the only way through which harmonization can be achieved.

Patient safety and better outcome for the patients needs to be our major goal and motivation.

e-mail: am [dot] simundic [at] gmail [dot] com


Harmonization of the analytical phase: manufacturer’s declarations

Nora Nikolac. Harmonization of the analytical phase: manufacturer’s declarations. Biochemia Medica 2015;25(Suppl 1):S23-S24.

University Department of Chemistry, University Hospital Centre Sestre milosrdnice, Zagreb, Croatia


During the last few decades, analytical phase of the laboratory work has been significantly improved. Today, only a small proportion of laboratory errors can be attributed to this phase. However, continuous efforts on harmonization are necessary to maintain the high quality of analytical procedures. This lecture will give an overview of potential pits and pitfalls of manufacturer’s declarations for laboratory reagents.

Declaration is a document that contains all relevant technical specifications about the product. An EU Directive IVD 98/79/EC Directive on in vitro diagnostic medical devices brings legal framework for all medical devices, including laboratory reagents. According to the document, manufacturers are obligated to perform extensive validation of methods and devices used for diagnostic purposes. Laboratory professionals should make sure that declared data can be replicated in the routine conditions. According ISO 15189 document, method documentation should comprise all relevant technical characteristics. Manufacturers have to provide those data for their users. However, manufacturer’s declarations are often incomplete, inaccurate, not harmonized and may contain data that cannot be verified in the practice.

Manufacturers usually comply with legal requisitions and most of them include data on precision, linearity and interferences into their package inserts. However, data on precision is highly heterogeneous in: type of material used for determination (control or patient samples), number of samples, concentration levels or precision components that are provided in the sheet (repeatability, between-run precision, within-day precision, between-day precision or within-laboratory precision).

When providing data on interferences, manufacturers should describe materials and methods used for creating interferences, interferent and analyte concentrations and measured bias values. Manufacturers often don’t declare this data. Acceptance criteria should be based on biological variation, but manufacturers often use the same criteria for all analytes (5 or 10%).

It is, therefore, very difficult to compare different reagents. In addition, it is sometimes impossible to replicate declared data and we have recently published several articles that confirm this finding.

Reasons, most likely, lie in the fact that the conditions in the user’s laboratories are different due to the large staff fluctuation or deterioration of the laboratory equipment. Also, sometimes different verification protocols can be used. It is, therefore obligation of reagent manufacturers to use valid guidelines in reagent validation and to present all relevant data using appropriate statistical measures. Laboratory professionals are obliged to verify the declared data and provide objective evidence for specification confirmation. Harmonization efforts are required from both sides.

e-mail: nora [dot] nikolac [at] gmail [dot] com


Harmonization of postanalytical phase: laboratory results that represent critical-risk to the patients’safety

Eva Ajzner1,2,Tünde Miklós1.  Harmonization of postanalytical phase: laboratory results that represent critical-risk to the patients’safety. Biochemia Medica 2015;25(Suppl 1):S24-S25.

1Jósa András University Hospital, Nyíregyháza, Hungary

2Task and Finish Group on Critical Results of the European Federation of Clinical Chemistry and Laboratory Medicine and the Australasian Association of Clinical Chemistry

Although critical laboratory test results may have significant impact on medical decisions and on subsequent patient outcomes there is limited guidance on best practices of the management of laboratory results that represent critical-risk to the patients’ safety (CR). Recognizing the need for harmonized standards in the field the Croatian Society of Medical Biochemistry and Laboratory medicine joined to the international survey organized by the Task and Finish Group on Critical Results of the European Federation of Clinical Chemistry and Laboratory Medicine and the Australasian Association of Clinical Biochemistry on CR management policies and alert thresholds of common biochemistry analytes. Croatian laboratories were invited to this international survey with a goal to collect existing practices in the management of CR countrywide and to compare the participants’ CR lists applied in everyday practice.

Thirtytwo laboratories responded to the survey and nine laboratories shared their CR lists. We observed a great variation in CR management practices and detected a failure in reading back results when CR notification was done by telephone in 70% of the responding laboratories. The fundamental requirement for a shared policy between laboratory and clinical staff was often not fulfilled. Only 13% of respondents reported that relevant physicians were involved in decisions of which tests should be included in the laboratory’s critical result list. Alert thresholds were established in consultation with doctors in only 22% of the responding laboratories. Procedures for the maintenance and monitoring of the outcome of critical result management have also shown variations and shortcomings of current practices: 47% of respondents review their critical result list on a regular basis; 37% regularly monitor whether critical results are delivered within predetermined timeframes; and 27% of laboratories audit regularly their performance of delivering critical results.

Our results confirm the large within country variations in CR management described in the literature and highlight the need for best practice recommendations for more efficient communication of CR.

e-mail: ajzner [at] med [dot] unideb [dot] hu