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1.
Kucinskiene ZA Bartlingas J 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2011,21(1):43-48
In Lithuania there are two types of specialists working in medical laboratories and having a university degree: laboratory medicine physicians and medical biologists. Both types of specialists are officially being recognized and regulated by the Ministry of Health of Lithuania. Laboratory medicine physicians become specialists in laboratory medicine after an accredited 4-year multidisciplinary residency study program in Laboratory Medicine. The residency program curriculum for laboratory medicine physicians is presented. On December 9, 2009 the Equivalence of Standards for medical specialists was accepted and Lithuanian medical specialists in Clinical Chemistry and Laboratory Medicine can now apply for EC4 registration. Medical biologists become specialists in laboratory medicine after an accredited 2-year master degree multidisciplinary study program in Medical Biology, consisting of 80 credits. Various postgraduate advanced training courses for the continuous education of specialists in laboratory medicine were first introduced in 1966. Today it covers 1-2-week courses in different subspecialties of laboratory medicine. They are obligatory for laboratory medicine physicians for the renewal of their license. It is not compulsory for medical biologists to participate in these courses. The Centre of Laboratory Diagnostics represents a place for the synthesis and application of the basic sciences, the performance of research in various fields of laboratory medicine, as well as performance of thousands of procedures daily and provision of specific teaching programs. 相似文献
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Ho B Ho E 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2012,22(2):247-257
Introduction:
ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009.Materials and methods:
Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods – from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009.Results:
For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023).Conclusion:
Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories. 相似文献4.
Ivana Lapi&#x; Dunja Rogi&#x; Matea Ivi&#x; Marina Tomi
evi&#x; Mirjana Mariana Kardum Paro Lovorka &#x;erek Ines Alpeza Viman 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2021,31(2)
IntroductionEffective implementation and continual compliance with ISO 15189:2012 require ongoing commitment and active involvement of laboratory staff. Our aim was to assess attitudes regarding accreditation implementation by conducting a survey in three Croatian accredited medical laboratories.Materials and methodsAn anonymous survey consisting of 34 questions was distributed either electronically or in a paper form a week prior to scheduled annual audits. Distributions of answers regarding age, work experience, laboratory workplace, and education level and according to the respective laboratory were compared.ResultsThe overall response rate was 76% (225/297). Preference towards working in an accredited laboratory and a positive attitude were revealed by 70% and 56% participants, respectively, with better process documentation as the main advantage. Only 14% of responders considered themselves completely familiar with ISO 15189:2012. Total of 68% of responders felt that accreditation increases the usual workload, with excessive paperwork as the main contributor. Half of the responders declared partial agreement that accreditation requirements and expectations were clearly explained and claimed that their suggestions were taken into account only occasionally, which was especially emphasized by technical staff. The vast majority (89%) completely follow the prescribed protocols. Only 27% consider turnaround time monitoring useful. Competence assessment is considered efficient by 41% of responders. The majority (73%) prefer an online audit in times of COVID-19.ConclusionsDespite an overall positive attitude towards accreditation, further efforts are needed in providing better education about ISO 15189:2012 for technical staff and modifying formats of competence assessment, in order to achieve better adherence to ISO 15189:2012 requirements. 相似文献
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Simundic AM Topic E Cvoriscec D Cepelak I 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2011,21(1):15-21
Heterogeneity exists across Europe in the definition of the profession of clinical chemistry and laboratory medicine and also in academic background of specialists in this discipline. This article provides an overview of the standards of education and training of laboratory professionals and quality regulations in Croatia. Clinical chemistry in Croatia is almost exclusively practiced by medical biochemists. Although term Medical biochemist often relates to medical doctors in other European countries, in Croatia medical biochemists are not medical doctors, but university degree professionals who are qualified scientifically. Practicing the medical biochemistry is regulated by The Health Care Law, The Law of the Medical Biochemistry Profession and The Law of the State and Private Health Insurance. According to the law, only medical biochemists are entitled to run and work in the medical biochemistry laboratory. University degree is earned after the 5 years of the studies. Register for medical biochemists is kept by the Croatian Chamber of Medical Biochemists. Licensing is mandatory, valid for 6 years and regulated by the government (Law on the Health Care, 1993). Vocational training for medical biochemists lasts 44 months and is regulated by the national regulatory document issued by the Ministry of Health. Accreditation is not mandatory and is provided by an independent, non-commercial national accreditation body. The profession has interdisciplinary character and a level of required competence and skills comparable to other European countries. 相似文献
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Beregova O 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2011,21(1):38-42
The question of the medical laboratories staff training is currently in the focus of attention in Ukraine. Laboratory technicians with a college degree are prepared in the medical colleges for two or four years depending on school educational level. During their practice they are assessed every five years on completing the additional improving course. The position and their job responsibilities are defined by the Ministry of Health Protection. Bachelors of clinical laboratory diagnostics (CLD) are trained in medical universities obtaining the appropriate license. The position and their job responsibilities are similar to laboratory technicians' ones. The CLD specialists are prepared by the CLD departments in the medical academies of postgraduate education or medical universities' faculties of postgraduate studies. Those graduates, who have already acquired a degree in Medicine or Biology are eligible for the training program. Biologists pass courses of specialization for five month whereas doctors pass the specialization for ten month including four month practice. If the doctors wish, they can do the masters degree program within doing the specialization. However, because their position and job responsibilities are not determined by the Ministry of Health Protection of Ukraine, masters are allowed to practice their profession at the level of specialists. The specialists that practice clinical biochemistry, laboratory immunology, microbiology and medical genetics have to take the additional appropriate two-three month specialization courses. During their practice, specialists are assessed every five years. For assessment the commission takes into account the quantity of credits that a specialist has received within five years. Credits are earned for attending the scientific conferences, publishing scientific works, books or handbooks, professional training and pre-assessment module courses. The position and their responsibilities are defined by the Ministry of Health Protection of Ukraine. Currently there is no system in Ukraine for higher academic education for professionals in clinical laboratory diagnostics. We are aware of this fact and are committed to the improvement of the Ukrainian teaching clinical laboratory diagnostics system. 相似文献
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Winterhalter-Jadrić M Causević A Jadrić R Corić J Hasić S Kiseljaković E 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2011,21(1):12-14
In this paper we would like to briefly introduce readers to the situation in the field of laboratory medicine in Bosnia and Herzegovina, with a focus on training in the field of medical biochemistry. As in some of neighboring countries, term Medical biochemist is the usual name for the Clinical biochemist or Clinical chemist in Bosnia and Herzegovina. Despite the difficult period through which the profession had passed in the last two decades, laboratory work, particularly clinical biochemistry, has managed to retain the necessary quality and keep pace with the developed world. In post war period, Society of Medical Biochemists of Bosnia and Herzegovina held regular meetings each year as a part of "life long learning" process, where both scientific and vocational lecturers presented their work. A single law on the state level would provide us with more defined and precise answers, such as: who can get a specialization, how long should last the training for medical biochemistry specialists (duration in years). This law should be in consent with the program described in EC4 or other documents given by the EFCC (European Federation of Clinical Chemistry and Laboratory Medicine) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine). 相似文献
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Pilar Fernandez-Calle Sandra Pelaz Paloma Oliver Maria Jose Alcaide Ruben Gomez-Rioja Antonio Buno Jose Manuel Iturzaeta 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2013,23(1):83-95
Introduction
Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown.Materials and methods:
A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients’ samples in both devices.Results:
27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein.Conclusions:
A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results. 相似文献9.
Raúl Rigo-Bonnin Noelia Díaz-Troyano Laura García-Tejada Albert Marc-Galindo Míriam Valbuena-Asensio Francesca Canalias 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2021,31(1)
Clinicians request a large part of measurements of biological quantities that clinical laboratories perform for diagnostic, prognostic or diseases monitoring purposes. Thus, laboratories need to provide patient’s results as reliable as possible. Metrological concepts like measurement uncertainty and metrological traceability allow to know the accuracy of these results and guarantee their comparability over time and space. Such is the importance of these two parameters that the estimation of measurement uncertainty and the knowledge of metrological traceability is required for clinical laboratories accredited by ISO 15189:2012. Despite there are many publications or guidelines to estimate the measurement uncertainty in clinical laboratories, it is not entirely clear what information and which formulae they should use to calculate it. On the other hand, unfortunately, there are a small number of clinical laboratories that know and describe the metrological traceability of their results, even though they are aware of the lack of comparability that currently exists for patient’s results. Thus, to try to facilitate the task of clinical laboratories, this review aims to provide a proposal to estimate the measurement uncertainty. Also, different suggestions are shown to describe the metrological traceability. Measurement uncertainty estimation is partially based on the ISO/TS 20914:2019 guideline, and the metrological traceability described using the ISO 17511:2020. Different biological quantities routinely measured in clinical laboratories are used to exemplify the proposal and suggestions. 相似文献
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Yang Fei Rong Zeng Wei Wang Falin He Kun Zhong Zhiguo Wang 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(2):213-221
Introduction
To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones.Materials and methods
479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires.Results
The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories.Conclusions
Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.Key words: quality indicators, quality control, clinical laboratory services 相似文献11.
《Research Policy》2022,51(1):104372
Exclusivity is a key concern when designing a licensing contract, yet the organizational factors that influence the exclusive provision of university licenses remain underexplored. This study provides a deeper understanding of this question by developing a balanced framework that considers both licensors (universities) and licensees (companies) in licensing deals. Furthermore, we posit that university prestige affects both a university's ability to conduct non-exclusive licensing and a firm's incentive to obtain an exclusive license, thereby shaping their joint willingness to license (non-)exclusively. We also examine how technology transfer office (TTO) experience and prior collaboration between a university and a firm moderate this relationship. To test the hypotheses, we use a dataset consisting of 6653 licensed patents owned by 117 representative Chinese universities. We find that an inverted U-shaped relationship exists between university prestige and the likelihood that two parties choose exclusive licensing. Moreover, the moderating effect of TTO experience is partially supported while that of prior collaboration is fully supported. Our findings generate important implications for the relative social impacts of exclusive and non-exclusive licensing of technology inventions as well as the management of university licensing. 相似文献
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Lora Duki? Ana-Maria ?imundi? 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2014,24(2):281-292
Introduction:
The aim of this survey study was to assess the current practices and policies in use related to the various steps in the blood gas testing process, across hospital laboratories in Croatia.Materials and methods:
First questionnaire was sent by email to all medical biochemistry laboratories (N = 104) within general, specialized and clinical hospitals and university hospital centres to identify laboratories which perform blood gas analysis. Second questionnaire with detailed questions about sample collection, analysis and quality control procedures, was sent only to 47 laboratories identified by the first survey. Questionnaire was designed as combination of questions and statements with Likert scale. Third questionnaire was sent to all participating laboratories (N=47) for additional clarification for either indeterminate or unclear answers.Results:
Blood gas analysis is performed in 47/104 hospital laboratories in Croatia. In 25/41 (0.61) of the laboratories capillary blood gas sampling is the preferred sample type for adult patient population, whereas arterial blood sample is preferentially used in only 5/44 laboratories (0.11). Blood sampling and sample processing for capillary samples is done almost always by laboratory technicians (36/41 and 37/44, respectively), whereas arterial blood sampling is almost always done by the physician (24/29) and only rarely by a nurse (5/28). Sample acceptance criteria and sample analysis are in accordance with international recommendations for majority of laboratories. 43/44 laboratories participate in the national EQA program. POCT analyzers are installed outside of the laboratory in 20/47 (0.43) institutions. Laboratory staff is responsible for education and training of ward personnel, quality control and instrument maintenance in only 12/22, 11/20 and 9/20 institutions, respectively.Conclusions:
Practices related to collection and analysis for blood gases in Croatia are not standardised and vary substantially between laboratories. POCT analyzers are not under the direct supervision by laboratory personnel in a large proportion of surveyed institutions. Collective efforts should be made to harmonize and improve policies and procedures related to blood gas testing in Croatian laboratories. 相似文献13.
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基于我国高校与企业间的专利许可数据，本文研究技术成熟度、校企之间的地理距离和校企合作经验如何影响高校采取排他性许可的倾向。当商业化高校的技术伴随着高风险时，企业承诺投入必要资源的意愿降低。本研究认为，合理的许可合同设计是高校解决该问题的方式之一。排他性许可作为高校创造共同承诺的机制，能够减轻技术不成熟、地理距离劣势和缺少合作经验给企业带来的风险，激励企业投入互补性资产，促进高校科技成果产业化。实证结果表明，技术成熟度越低，高校与企业的合作经验越少，高校采用排他性许可的倾向越高。同时，随着地理距离增加，技术成熟度减少高校进行排他性许可倾向的关系会被削弱。 相似文献
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T. F. Hartley 《Indian journal of clinical biochemistry : IJCB》2010,25(1):92-98
The aim of this study was to design an audit questionnaire that focuses on the management of the technical activities in a
Diagnostic Pathology Laboratory. The ISO 15189 Standard is written in such a way that it continually moves back and forth
from topics where the auditor needs to question bench level staff, to topics where the auditor needs to question Technical
Management Staff. This makes for a disjointed audit process — both Bench Staff and Technical Managers are repeatedly interrupted.
The solution was to do a clause by clause analysis of the Standard and assign the major responsibility for the compliance
to each clause to either Technical Managers or Bench Staff. The Clauses were then grouped under four topic headings regardless
of whether they were a Section 4 or Section 5 Clause. Two questionnaires have emerged — the one described in this work and
one directed primarily towards the activities of bench staff. There are 95 questions and it takes approximately two hours
to complete. 相似文献
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Gabriel Lima-Oliveira Giuseppe Lippi Gian Luca Salvagno Giorgio Brocco Gian Cesare Guidi 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(2):273-278
Introduction
In vitro human diagnostic (IVD) company recalls are a common practice aimed to either minimize a potential error or eliminate an existing failure. In this case report, we aim to provide a critical analysis of a recent IVD recall and to provide a practical framework about what to do when an IVD company recalls product(s) based on the International Organization for Standardization - ISO 15189:2012 standard.Case report
In 2014, Abbott Laboratories® (Green Oaks, IL) published an urgent field safety notice regarding a product recall (Architect Intact parathyroid hormone (PTH) Assay List Number 8K25) with immediate action required. The IVD company explained the reasons for the recall as follows: i) Abbott has confirmed that a performance shift in the Architect Intact PTH assay has the potential to generate falsely elevated results on patient samples; ii) results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. This issue may also impact established Architect Intact PTH reference ranges; iii) the magnitude of shift averages approximately 13% to 45%; iv) Abbott Architect Intact PTH controls do not detect the shift; and v) all current reagent, calibrator, and control inventory are impacted. The recall could have resulted in ~40,000 inaccurate laboratory tests reported by 18 laboratories from Italy (Lombardy region).Conclusion
IVD company recalls have a serious impact on the patient safety and require a thorough investigation and responsible approach to minimize the possible damage. Medical laboratories accredited according to the ISO 15189 standard have procedures in place to manage such situations and ensure that patient safety is maintained when such recalls are issued.Key words: clinical laboratory techniques, patient safety, laboratory variability, reference standards, quality control, parathyroid hormone 相似文献18.
Vanja Radi?i? Biljak Lorena Honovi? Jasminka Matica Branka Kne?evi? Sanela ?imi? Vojak 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(1):73-83
Introduction
Early identification and management of chronic kidney disease (CKD) is highly cost-effective and can reduce the risk of kidney failure progression and cardiovascular disease. In 2014, the Joint Croatian Working Group (JCWG) for laboratory diagnostic of CKD on the behalf of Croatian society of medical biochemistry and laboratory medicine (CSMBLM) and Croatian chamber of medical biochemists (CCMB) conducted a survey across Croatian medical-biochemistry laboratories to assess the current practice in this area of laboratory medicine. The aim of this study was to present the data collected through the survey and to give insight about laboratory diagnostics of chronic kidney disease in Croatia.Materials and methods
An invitation to participate in the survey was sent to all Croatian medical-biochemistry laboratories (N = 196). The questionnaire was designed in a form of questions and statements, with possible multiple answers, comprising 24 questions.Results
The response rate was 80/196 (40.8%). 39 answers were from primary medical-biochemistry laboratories. 31/78 (0.40) laboratories measure creatinine with non-standardized method (uncompensated Jaffe method). 58/78 (0.74) of laboratories that measure creatinine do not report eGFR values. Similar number of laboratories (58/80, 0.73) do not measure urine albumin or protein.Conclusions
There is a large heterogeneity among Croatian laboratories regarding measuring methods, reporting units and reference intervals (cut-off values), both for creatinine and urine albumin or protein. The two key prerequisites for CKD screening, automatic reporting of eGFR and albuminuria or proteinuria assessment, are not implemented nationwide. There is a need for harmonization in laboratory diagnostics of CKD in Croatia.Key words: survey, chronic kidney disease, estimated glomerular filtration rate (eGFR), albuminuria, proteinuria, creatinine, harmonization 相似文献19.
By using the PatVal-EU dataset we find that the most important determinant of patent licensing is firm size. Patent breadth, value, protection, and other factors suggested by the literature also have an impact, but not as important. In addition, most of these factors affect the willingness to license, but not whether a license actually takes place. We discuss why this suggests that there are transaction costs in the markets for technology. The issue is important because many potential licenses are not licensed suggesting that the markets for technology can be larger, with implied economic benefits. 相似文献