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Daria Pašalić
Editor-in-Chief
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

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S06-1

Šimundić AM.S06-1: Quality indicators. Biochemia Medica 2009;19(Suppl 1):S49-S50.
University Department of Chemistry, Sestre Milosrdnice University Hospital, Zagreb, Croatia
Corresponding author:am [dot] simundic [at] gmail [dot] com
 
Abstract
 
Total Quality Management is a specific approach to the management in a laboratory that aims to provide products and services that fully meet the needs of the both patients and clinical staff. The key prerequisite to the successful implementing TQM is a continuous system improvement based on the indicators of key processes and activities. Those indicators are called quality indicators and are defined as measurable, objective, quantitative measures of key system elements performance. To systematically monitor and evaluate quality indicators of the system is a must for each ISO15189 accredited clinical laboratory. Quality indicators may be used to measure the quality of the key, strategic and support processes. It is important that all three key processes in the laboratory (preanalytical, analytical and postanalytical) are addressed. Besides for self-evaluation, quality indicators are also used for benchmarking. Since most errors occur in the preanalytical phase it is the segment having major potential for improvement. Besides well established proficiency testing for the external independent evaluation of analytical phase of laboratory processes, some preanalytical and postanalytical external quality assurance programs have also emerged. Such programs cover the issues of patient identification, sample quality and appropriateness, TAT, critical values reporting, corrected and withdrawn reports, test request errors and some other. External quality assurance programs for postanalytical phase have also been introduced and mostly relate to the quality of interpretative comments. Harmonizing the extraanalytical phase of laboratory diagnostics is essential to the national as well as to the international level, since it represents the major contribution to the quality of the laboratory testing process and the patient care.
S06-2
Challand G. S06-2: External quality assurance for the post-analytical phase. Biochemia Medica 2009;19(Suppl 1):S50-S51.
Royal Berkshire Hospital, Clinical Biochemistry Department, Reading, Berkshire, United Kingdom
Corresponding author:gqn62 [at] dial [dot] pipex [dot] com
 
Abstract
 
Errors in the post-analytical phase of laboratory medicine, particularly in incorrect interpretation of laboratory results, have been estimated to be at least 20% of all errors ascribable to laboratory professional staff. But there is a growing need for laboratory professionals to offer advice on the interpretation of results, typically by adding a brief interpretative comment to a report. Surprisingly little evidence-base data exists to support interpretation of laboratory test results, and interpretative comments accompanying laboratory reports are complex, usually consisting of several components which may suggest possible diagnoses and additional investigations. Every comment is different, and assessment of interpretation is difficult. Different approaches can be used: assessing whole comments or components of comments; and using independent assessors or a pooled panel of experts. No approach can be considered to be a “gold standard“ since assessment is an imperfect science and is a guide to, not a definition of unequivocal solutions. External Quality Assurance Schemes examining interpretation can provide information to individual participants on how their comments compare with others, but their primary purpose is educational and such Schemes enable us to gather knowledge on how to better establish and develop interpretation. The UK Scheme started in 2001, and provides strong evidence that participation in such Schemes improves laboratory practice.
S06-3
Perkov S.S06-3: How to manage unsuitable specimens? Biochemia Medica 2009;19(Suppl 1):S51-S52.
Institute of Clinical Chemistry, Merkur University Hospital, Zagreb, Croatia
Corresponding author:sonja [dot] perkov [at] hdmb [dot] hr
 
Abstract
 
Systematic control of the total analytical process with continuous monitoring and management of non-conformities is the obligation of all medical laboratories accredited according to ISO 15189: 2003. Although preanalytical quality standards are well defined at international and national level, the most errors in laboratory medicine occur in the preanalytical phase. Unsuitable samples due to misidentification, quantity (insufficient volume to perform the analysis, inadequate blood /anticoagulant ratio) or quality issues (hemolitic, cloted, contaminated specimens, or samples collected in the wrong container) represent the leading preanalytical problem.
In 2007, the Study Group on Extra-analytical Variability convened by representatives of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC), Italian Society of Laboratory Medicine, (SIMeL) and Italian Committee for Standardization of Hematological and Laboratory Methods (CISMEL) have proposed a series of recommendations to promote, standardize and harmonize management of unsuitable samples in clinical laboratories. These recommendations include staff education and responsibility, the implementation of objective and standardized criteria and procedures for detecting unsuitable samples and management of unsuitable samples.
Education of health workers involved in the processes of collecting, handling, preparation and transport of samples is crucial for understanding the impact of preanalytical factors on the quality of the sample. Since standardized preanalytical procedures can reduce the impact of short-term biological and methodological factors, the instructions for collecting, handling and transport of samples must be clear, easily intelligible and available to all healthcare operators involved in preanalytical processes, both within and outside the clinical laboratory. For effective implementation of the above procedures, it is necessary to ensure continuous communication and cooperation between all members of the health team.
Hemolysis, lipemia, and icterus are factors that mostly affect the quality of the sample. Intensity of the interference depends on the method and the analyte. Application of technology that can automatically detect and if necessary correct a wide range of analytical interference, including hemolysis, lipemia, and icterus, as well as insufficient or clotted specimens is recommended, since this would help to overcome the subjectivity of visual inspection, increasing sensitivity in the detection of unsuitable samples and harmonizing behavior of engaged health staff.
The laboratory should clearly specify within its operation procedures the type of unsuitable specimens and the procedures adopted for their identification, the type of the analyses that may be influenced by the presence of a given interfering substance and applied solutions for the management of identified non-conformities. Procedures for hemolized samples handling and instructions for rejection of the samples, which are defined at the national level by the Commission for technical questions of the Croatian Chamber of Medical Biochemists (www.hkbm.hr) must be followed.
Special problem in management of unsuitable samples are inadequately labeled samples. Although their representation is minimal in relation to other unsuitable samples, consequences that may arise due to wrong or unnecessary diagnostic and therapeutic procedure can be very difficult.
According to the standards of good laboratory practice (www.hkmb.hr), each laboratory should develop its own strategy for identification, detection and monitoring of unsuitable samples. Implementation of international recommendations with the continuous monitoring of unsuitable specimens and analysis of factors associated with rejection, and start of the appropriate correctional action, can reduce errors and promote continuous quality improvement of the whole analytical process.
S06-4
Bilić-Zulle L1,2, Šimundić AM3, Nikolac N3, Šupak Smolčić V1, Honović L4.S06-4:Control of extra-analytical phase of the laboratory diagnostics – European perspective. Biochemia Medica 2009;19(Suppl 1):S53-S54.
1Department of Laboratory Diagnostics, Rijeka Clinical Hospital Centre, Rijeka, Croatia
2Department of medical informatics, Rijeka University School of Medicine, Rijeka, Croatia
3University Department of Chemistry, Sestre Milosrdnice University Hospital, Zagreb, Croatia
4Laboratory of Cinical Chemistry, Pula General Hospital, Pula, Croatia
Corresponding author:lidija [dot] bilic-zulle [at] medri [dot] hr
 
Abstract
 
Background: Quality control of analytical phase of laboratory diagnostics is well established and standardized procedure. However, extra-analytical phase can be source of significant mistakes and its quality control is still developing and it is not widely applied. Aim of the study is to evaluate procedures of extra-analytical phase of laboratory diagnostics in European laboratories.
Subjects and methods: The results were collected from laboratory personnel using anonymous questionnaire with 20 Likert scaled questions to test frequency (never = 1, rarely = 2, often = 3, always = 4 and sign x if subject was not involved in described procedure) of representative procedures of extra-analytical phase with recoding of negative questions. Answers were expressed as average grade 1.0 - 4.0. There were three groups of questions: criteria of acceptance of sample (N = 6), procedures of phlebotomy (N = 6), reporting of results (N = 7) and one separate question about recording of nonconformities in work. The questionnaire was completed by 460 subjects (17 excluded from data analysis) from 12 laboratories from 10 countries (3 laboratories from Croatia and one from each of following countries: Bosnia and Herzegovina, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine). Data collected on laboratories were: diagnostics services, accreditation status, personnel structure, status of laboratory information system, and existence of written and accessible procedures for extra-analytical phase. Subjects’ median age was 42 ranged from 20 to 75 years; 93% of women; 43% high school graduated, 35% with college degree (B.Sc) and 22% university graduated. Computer skills were self-estimated as good by 29%, intermediate by 62% and poor by 9% of subjects.
Results: Average grade of all answers in whole subject group was X ± SD = 3.1 ± 0.3. There is no difference in average grade regarding to subjects’ professional qualification, primary profession (health or other) or computer skills. There is no correlation between average grade and age of subjects. Nonconformities are never or rarely documented by 30% of subjects while 70% do it often or always. There is statistically significant difference between average grade of three groups of questions: criteria of acceptance of sample, procedures of phlebotomy and reporting of results 3.1 ± 0.6 vs. 2.8 ± 0.6 vs. 3.3 ± 0.5 (P < 0.001). Statistically significant difference (P < 0.001) was revealed between subjects from laboratories that are not accredited (3.0 ± 0.3, N = 272) and from those laboratories that are in preparation for accreditation (3.2 ± 0.3, N = 63) or already accredited (3.3 ± 0.2, N = 108). Subjects from laboratories that participate in some form of external quality control for extra-analytical phase of laboratory diagnostics have higher average grade (3.2 ± 0.3, N = 129) than those from laboratories that do not participate in such QC programs (3.1 ± 0.4; N = 314); P = 0.025.
Conclusions: Quality control of extra-analytical phase of laboratory diagnostics is mandatory in process of establishing high standards of good laboratory practice. The weakest part of extra-analytical phase is sample collection e.g. phlebotomy procedures. That part so as all procedures of extra-analytical phase needs more education, quality control and emphasizing the importance of high quality of such procedures. External quality control for extra-analytical phase and accreditation procedures significantly raise the quality of extra-analytical procedures.
S06-5
Honović L1, Šimundić AM2, Bilić-Zulle L3,4, Nikolac N2, Šupak Smolčić V3.S06-5: Control of pre-analytical phase of the laboratory diagnostics-results of Croatian survey. Biochemia Medica 2009;19(Suppl 1):S54-S55.
1Laboratory of Clinical Chemistry, Pula General hospital, Pula
2University Department of Chemistry, Sestre Milosrdnice University Hospital, Zagreb, Croatia
3Department of Laboratory Diagnostics, Rijeka Clinical Hospital Centre, Rijeka, Croatia
Corresponding author:lhonovic [at] obpula [dot] hr
 
Abstract
 
Introduction: Control of pre-analytical phase of the laboratory diagnostics is partly represented by expert controls of Croatian Chamber of Clinical Chemistry. The aim of the study presented was to determine everyday use of the most important procedures and standards of pre-analytical phase of the laboratory diagnostics in Croatia.
Materials and methods: The results were collected from members of Croatian Chamber of Clinical Chemistry using anonymous questionnaire with 20 Likert scale questions to testing frequency (never = 1, rarely = 2, often = 3, always = 4) of representative procedures of pre-analytical phase with recoding of negative questions. Answers were expressed as average grade 1.0-4.0. There were three groups of questions: criteria of acceptance of sample (6), procedures of phlebotomy (6), reporting of results (7) and one separate question about recording of non-conformity in work. The questionnaire was completed by 144 subject (rate response 27%) with median age 47 ranged from 26 to 65 years, 93% women. Subjects were 57% clinical chemist, 40% specialists and 3% professors; 96% of subjects graduated from Faculty of Pharmacy and Biochemistry; 62% had good computer skills; 40% of subjects work in primary care laboratories, 15% in laboratories of general hospitals, 13% in special hospitals, 12% in clinical hospitals, 13% in university hospital centers and 7% in private laboratories.
Results: Average grade of all answers in whole subject group was X ± SD = 3.1 ± 0.4. There was no difference regarding type of laboratory and institution, professional degree or computer skills. There was no correlation between average grade and age. There is statistically significant difference between average grade of three groups of questions: criteria of acceptance of sample 3.3 ± 0.5 vs. procedures of phlebotomy 2.8 ± 0.5 vs. reporting of results 3.2 ± 0.5 (P < 0.001). 21% of subject never or rarely record nonconformities in work while 79% often or always.
Conclusion: Although average grade of 3.1 may seems high, the lowest grade of phlobotomy phase reveals the neediness for additional education on primary sample collection and control of all non-analytical phases.