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result, the overall project liability concerning the time of completion and quality management falls on the GC as presented in Table 1 . Table 1. Comparison between DBB and DB delivery methods and projects Metrics DBB type of contract DB type of contract
Abstract
Increasingly govemmental bodies and industry require that supporting analytical laboratories have their quality assurance program implemented in a quality system by international standards such as derived from the ISO-25 guide. Neutron activation analysis (NAA) laboratories may have to deal with this trend too. In universities and research laboratories the need for it, and the implications of total quality management system are sometimes misconceived by unfamiliarity with the issue. The laboratory for INAA in Delft has been accredited for its quality system since 1993. Some of the tangible improvements since the introduction of quality management are presented. Four strategical considerations are given to consider the introduction of quality management at NAA laboratories, viz. with respect to the role of NAA for the validation of other methods, the role of NAA in the certification of reference materials, the preservation of knowledge and the acceptance of NAA as a respectable method.
Abstract
The establishment of a quality management system is the best way to comply with international requirements concerning the achievement of confident and traceable analytical results. Some important points dealing with the technical factors of quality management in gamma-ray spectrometry of environmental samples are discussed. The experience obtained from analytical procedure validation is presented. Results of the application of standardized procedures to the analysis of ALMERA intercomparison samples, as well as the outcome of the utilization of certified reference materials for the quality control of measurement are presented. In fact, the implantation of simple technical principles reports reliable results and allows to elevate the quality of the measurements at a cost relatively low according to the real possibilities of the small laboratories, even in developing countries.
Abstract
Except the nuclear fuel reprocessing and nuclear materials safeguards, at present there are two areas of an increased responsibility of nuclear scientists for their results: radioecology and human medicaments. At both of them, quality and trustfulness of results is of great importance for their end-users and may have serious economical and legal consequences. The trends of implementation of good laboratory and manufacturing practices under umbrella of international quality management standards like ISO 17025:2005 and ISO 9001:2000 in radiochemical and radiopharmaceutical laboratories are discussed as expanding to “good scientific practice”. The case studies of the Comenius University laboratory LARCHA authorized for radiochemical analysis, and the company BIONT producing medical radionuclides and PET radiopharmaceuticals are used as the examples.
ISO 9000:2005: Quality management systems. Fundamentals and vocabulary . 3 MSZ EN ISO 9000:2005: Minőségirányítási rendszerek . Alapok és szótár. 4 ISO 3534
, accreditation, EFQM and ISO assessment in European Union countries. External Peer Review Techniques. European Foundation for Quality Management. International Organization for Standardization. Int. J
Laffel, G., Blumenthal, D.: The case for using industrial quality management science in health care organizations. JAMA, 1989, 262 , 2869–2873. Blumenthal D. The case for using
Összefoglaló. A székletmikrobiota-transzplantáció (faecalismikrobiota-transzplantáció – FMT) a Clostridioides difficile fertőzés (CDI) kezelésében nemzetközileg széles körben elfogadott, megfelelő szakmai háttér mellett végezve biztonságos, potenciálisan életmentő, költséghatékony, valamint a hospitalizációs idő és az orvos-beteg találkozások jelentős redukálására képes eljárás. Az FMT elvégzésére egyes országokban magas szintű minőségirányítási háttérrel működő, célfeladatra szerveződött donor- és székletbankok rendezkedtek be. Máshol, így például hazánkban, az eljáráshoz az egyértelmű jogi szabályozási környezet, a standardizált technológiai háttér és a finanszírozás hiánya miatt nem egységes a hozzáférés. Régóta időszerű továbbá, hogy a heterogén, nemegyszer háztartási eszközökkel előkészített beavatkozások helyett a nemzetközi és legújabban már a hazai ajánlásokban is megfogalmazott, a betegbiztonságot legjobban garantáló elvárások mellett történjen a széklettranszplantáció. Az új koronavírus (SARS-CoV-2) okozta pandémia megjelenése erőteljes szakmai érv országos szinten az FMT minőségirányítási környezetének és technológiai hátterének újragondolására, mert a SARS-CoV-2 egyszerre jelent kockázatot a CDI miatt kórházban kezelt sérülékeny betegpopulációnak, és egyben veszélyezteti az FMT biztonságosságát mind a recipiens, mind pedig az eljárást végző egészségügyi személyzet tekintetében. Ezekre a szakmai és társadalmi kihívásokra reagálva, a széles körű beteghozzáférés és a legmagasabb szintű betegbiztonság garantálására, a Debreceni Egyetemen új eljárásrendet dolgoztunk ki az FMT végzésére. Ezen eljárásrendnek a COVID–19-pandémia miatt módosított, a fagyasztottgraftbank üzemeltetése és a rendszerszemlélet tekintetében releváns elemeit ismertetjük. Javasolt, hogy országos szinten hasonló, megfelelő minőségirányítási és technológiai környezettel, a SARS-CoV-2-fertőzés kizárását is integráló donorszűrési rendszerrel, továbbá fagyasztottgraft-banki háttérrel működő laboratóriumok vegyenek részt a széklettranszplantációk végzésében. Felmerül továbbá, hogy az eljárást a számos analógia és a donor–recipiens koncepció alapján a sejt- és szövettranszplantációkra vonatkozó szabályozórendszer keretei közé ajánlott beágyazni. Orv Hetil. 2020; 161(44): 1858–1871.
Summary. Stool transplantation (faecal microbiota transplantation – FMT) is a widely accepted, potentially life-saving, cost-effective medical intervention for the treatment of Clostridioides difficile infection (CDI), which has an acceptable safety profile if performed with an appropriate professional background. FMT can significantly reduce hospitalization time and the number of patient visits. National donor and stool banks with high-standard quality management systems were established in certain countries for supporting the procedures. In other regions, including Hungary, patient access is not uniform due to the lack of clear legal regulations, standardized technology or financial reimbursement. It has been expected for a long time to replace the heterogenous techniques, occasionally utilizing household equipment with a technology providing improved patient safety and fulfilling international and recently published local FMT guidelines. The emergence of the novel coronavirus (SARS-CoV-2) pandemic is a very powerful argument in favour of urgently reconsidering the quality management and technological background of FMT procedures. SARS-CoV-2 is a major threat to the vulnerable patients suffering from CDI and also impose risks for the recipient and healthcare personnel involved in carrying out the transplantation. New FMT guidelines were implemented at the University of Debrecen to address these professional and public challenges, to provide wide patient access and to guarantee the highest achievable patient safety. Relevant elements of this new protocol are presented, focusing on a systemic quality management approach, on the operation of a frozen stool bank and on a modified donor screening algorithm taking the risks of COVID-19 into consideration. We suggest that laboratories with proper quality assurance and technological conditions, implementing SARS-CoV-2 donor screening and operating a frozen graft bank should participate in faecal microbiota transplantations. It is also recommended that, based on the analogies and the similar donor–recipient concept, FMT should be embedded under the organ tissue and cell transplantation polices in Hungary. Orv Hetil. 2020; 161(44): 1858–1871.
The present paper analyzes the possibilities for input qualification necessary for inversion of certain engineering geophysical measurement data series. The work formulates at first the requirements for determination of geophysical conclusions' reliability and/or accuracy. Then it reviews the quantities playing a role in qualification of geophysical data and geophysical conclusions deduced from the data. Statistical characterization of the e k = (y k - f k (x,z)) random differences between the y k geophysical measurement data and the f k (x,z) theoretical forward problem solutions calculated for the (x,z) model parameters is indispensable in quality controlled geophysical inversion. To qualify the { x } final result of inversion first of all the error components of observational and modelization origin of e k random differences should be determined. To give the s2 k variances of the e k differences characterizing the data-model relationship experimental testing should be carried out. To estimate the input errors of least squares type geophysical inversion approximate methods can be suggested beside the ideal testing procedures. Such are: the subjective, the literature-based, the partial and the feedback data-model relationship qualification. In addition to them for certain inversions using 1D and 2D forward problem solutions, self-control based model class adaptive engineering geophysical measurements can also be applied. According to the testing experiences gained with different approximate input qualifications not any theoretical speculation or sophisticated computation procedure is able to substitute the experimental measurement studies.
Enseignement des techniques d'enquête et formation à la qualité des étudiants en terminologie
Vizsgálati módszerek és minőségügyi kérdések tanítása hallgatóknak a terminológia részterületein
Summary
Teaching survey techniques and quality to students in terminology sections. Teaching quality in terminology is often focussed on the respect of a set of standards dealing with structuring, recording or validating data in a TDB. However, the scope of the terminologist's actions is much wider and requires a broader vision of quality approach. Training the students to survey techniques, which proved to play a fundamental role in language planning, appears to be very convenient to make them more sensitive to quality process. An experiment of this kind, developed in the framework of the Master in translation, section Terminology and Information society of the Institut Libre Marie Haps, and considering questionnaires at the same time as instruments for paedagogical integration, discovery, thought and communication will be exposed here. This project is carried by several members of the teaching staff and is considering several practical situations.
