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Quality assurance and management program of individual and environmental radiation protection equipment in a ISO 9001: 2008 Quality Management System
Abstracts/Physica Medica 32 (2016) e116–e123
D.410 ACTIVITY ESTIMATION IN PATIENTS SUBMITTED TO RADIOIODINE THERAPY FOR HYPERTHYROIDISM A. Ostinelli *,a, M. Duchini a, V. Conti a, P. Bonfanti a, S. Rossi b, M. Cacciatori a. a A. O. Sant’Anna, Como, Italy; b Università Insubria, Como, Italy Introduction: The 131I administered activities for the hyperthyroidism treatments are very high, with significant residual amounts in the following days. This paper proposes a mathematical algorithm that correlates patient activities and external measurements. The results are supported by clinical and experimental validations. Materials and Methods: The mathematical model is based on the relationship between activity, H*(10) rate, gamma constant and sourcedetector distance (d), without considering both the distribution of iodine and uptake through the tissues. An effective distance (deff) was introduced, adding a contribution dx to d, evaluating both the mean depth of the 131I 3D distribution and the photon-tissues interaction. Two measurements are required at known distances (d1 and d2). Applying the inverse square law to H*(10) rates and assuming C = (dH*2/dt)0.5/(dH*1/dt)0.5 and d1 + dx = C(d2 + dx); the residual activity is: F2dH*(10)/dt(d/gamma constant) where F = (d + dx)/d. Results: This model was validated by clinical trials, comparing the administered activities with the calculated ones. Comparing these results with the activities estimated by single measurements, the average deviation from the expected values decreases from 11% to 0.5%. Additional measurements were performed at the discharge time and four days after, with an 11.3% and 43.0% excreted mean activity. dx is about the radiopharmaceutical depth within the patient, with 82 ± 40, 56 ± 46 and 34 ± 36 mm average values at 0.5, 4 and 72 hours respectively. This decrease may be due to the gradual iodine capture by thyroid. Conclusions: This study proved the validity of the theoretical-experimental approach, providing a good estimation of the residual activity and an effective radiation protection tool. http://dx.doi.org/10.1016/j.ejmp.2016.01.417
D.411 “OPERRA” PROJECT ON PRIORITIES FOR RESEARCH IN THE FIELD OF RADIATION PROTECTION: DEVELOPMENT OF A SURVEY A. Palma *,a, S. Bouffler b, M. Coeck c, S. Della Monaca a, P. Fattibene a, S. Grande a, N. Impens c, G. Meskens c, I. Pecchia a, T. Perko c, A. Rosi a, F. Rollinger d, S. Salomaa e, L. Sirkka e, M.A. Tabocchini a, C. Turcanu c, M. Grigioni a. a Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma, Italy; b Centre for Radiation, Chemical and Environmental Hazards, Public Health England, Didcot, UK; c SCK CEN Belgian Nuclear Research Centre, Mol, Belgium; d Institut de Radioprotection e de Surete Nucleaire, Fontenay-aux-Roses, France; e STUK – Radiation and Nuclear Safety Authority, Helsinki, Finland Introduction: The EC OPERRA project (Open Project for the European Radiation Research Area) aims to create an innovative mechanism for the implementation of an instrument of joint programming that can be applied to all fields of research in radiation protection. In particular, the Task Group (TG) 4.3 aims to identify national and international stakeholders and to collect and analyse their opinions on research priorities in radiation protection. Within this TG, the ISS (TG 4.3.2 leader) has coordinated the creation of a survey in electronic format. Materials and Methods: The survey has been developed by the tool ZEF Evaluation Engine. Data analysis was performed by using ZEF, EXCEL and SPSS software. The questionnaire was organised with an initial section containing the synergistic priorities common to the European platforms MELODI, ALLIANCE, NERIS and EURADOS. The next four sections contained questions extracted respectively from each platform Strategic Research Agenda. Finally, other sections were devoted to issues related to ethical aspects of radiation protection, risk communication and risk perception, and education and training. Stakeholders to which the survey should be sent were identified from contact lists provided by the four platforms and by contacting the presidents of international scientific associations, the representatives of international organisations, etc. Each of them has been asked to spread the survey link to their members and/or advertise on their websites.
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Results and Conclusion: In the present work, some key results related to the synergistic priorities will be shown and discussed. The importance/ feasibility ranking was used for gathering opinion on these topics. Most responses came from those with interests in low dose risk and dosimetry. A complete analysis of the results is available on MELODI website (http://www.melodi-online.eu). A selection of such synergistic topics was recommended as the focus of the second OPERRA call for research proposals. http://dx.doi.org/10.1016/j.ejmp.2016.01.418 D.412 QUALITY ASSURANCE AND MANAGEMENT PROGRAM OF INDIVIDUAL AND ENVIRONMENTAL RADIATION PROTECTION EQUIPMENT IN A ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM M. Paolucci *, R. Di Lorenzo, A. Didona. USL Umbria 2 – Servizio Di Fisica Medica, Foligno, Italy Purpose: USL 2 Umbria was born in 2013 by merging 2 health care institutions; it’s organized into 6 districts and 8 regional hospitals, where the Medical Physics Department started a Quality Assurance (QA) and management system of Personal Protective Equipment (PPE) and mobile radiation shields, by placing them in the ISO 9001: 2008 Quality Management System. Materials and Methods: A multidisciplinary workgroup, including the Department of Diagnostic Imaging and Therapeutics and all departments and structures where radiation sources are used, was created. We started with census and efficiency check of all the equipment, through a dedicated QA program on all USL 2 Umbria radiological sites, in collaboration with technician staff. Subsequently a protocol for periodic functional and quality tests and a management procedure were established and a list with minimum necessary equipment for each radiological site was prescribed. Results: The Quality Management System was implemented over a period of about two years, establishing a management and monitoring paperwork, a program of audits and periodic QA tests on all the equipment, in order to ensure their correct efficiency, in compliance with regulatory requirements. During the QA campaign 483 PPE were tested, 5% of which was replaced with new equipment as resulted not suitable. We also disposed of 46 PPE unused because clearly damaged, following an internal procedure according to Italian legislation D. Lgs. 152/06. Furthermore a routine sanitization procedure for each PPE was established for their correct maintenance and conservation. Conclusion: The results led to an optimization of the equipment distribution, highlighting the need of continuous checks in order to provide a proper protection against ionizing radiation during clinical activities for patients and operators. http://dx.doi.org/10.1016/j.ejmp.2016.01.419 D.413 ISO 17025 ACCREDITATION EXPERIENCE OF AN INDIVIDUAL MONITORING SERVICE F. Rossi *, L. Fedeli, L. Noferini, M. Fedi, A. Falivene. Fisica Sanitaria AOU Careggi, Firenze, Italy Introduction: The European directives, according to ICRP recommendations, state that for people occupationally exposed to ionizing radiation a monitoring of absorbed dose is needed, the measuring instrument is called dosimeter. A service, called IMS (Individual Monitoring Service), is thus needed, providing not only the instruments but also calibrations, traceability of the name of worker related to dosimeter ID, proper storage of dose data, and so on. The Directive states that each member State shall develop approval procedures to state whether an IMS is or not suitable for its purpose. Italy is actually without any kind of approval procedure. Furthermore, the EC document RP160 states guidelines for IMSs, requiring compliance to ISO 17025 standard to fulfill adequate quality levels. Materials and Methods: Our IMS was updated to make it compliant with ISO 17025 standard. This involved: instrument maintenance, human resource proper training, operative procedures, traceability, calibrations, software, data recording and dose reporting. The updating was very timeconsuming, involving six persons two of them medical physicists.
D.410 ACTIVITY ESTIMATION IN PATIENTS SUBMITTED TO RADIOIODINE THERAPY FOR HYPERTHYROIDISM A. Ostinelli *,a, M. Duchini a, V. Conti a, P. Bonfanti a, S. Rossi b, M. Cacciatori a. a A. O. Sant’Anna, Como, Italy; b Università Insubria, Como, Italy Introduction: The 131I administered activities for the hyperthyroidism treatments are very high, with significant residual amounts in the following days. This paper proposes a mathematical algorithm that correlates patient activities and external measurements. The results are supported by clinical and experimental validations. Materials and Methods: The mathematical model is based on the relationship between activity, H*(10) rate, gamma constant and sourcedetector distance (d), without considering both the distribution of iodine and uptake through the tissues. An effective distance (deff) was introduced, adding a contribution dx to d, evaluating both the mean depth of the 131I 3D distribution and the photon-tissues interaction. Two measurements are required at known distances (d1 and d2). Applying the inverse square law to H*(10) rates and assuming C = (dH*2/dt)0.5/(dH*1/dt)0.5 and d1 + dx = C(d2 + dx); the residual activity is: F2dH*(10)/dt(d/gamma constant) where F = (d + dx)/d. Results: This model was validated by clinical trials, comparing the administered activities with the calculated ones. Comparing these results with the activities estimated by single measurements, the average deviation from the expected values decreases from 11% to 0.5%. Additional measurements were performed at the discharge time and four days after, with an 11.3% and 43.0% excreted mean activity. dx is about the radiopharmaceutical depth within the patient, with 82 ± 40, 56 ± 46 and 34 ± 36 mm average values at 0.5, 4 and 72 hours respectively. This decrease may be due to the gradual iodine capture by thyroid. Conclusions: This study proved the validity of the theoretical-experimental approach, providing a good estimation of the residual activity and an effective radiation protection tool. http://dx.doi.org/10.1016/j.ejmp.2016.01.417
D.411 “OPERRA” PROJECT ON PRIORITIES FOR RESEARCH IN THE FIELD OF RADIATION PROTECTION: DEVELOPMENT OF A SURVEY A. Palma *,a, S. Bouffler b, M. Coeck c, S. Della Monaca a, P. Fattibene a, S. Grande a, N. Impens c, G. Meskens c, I. Pecchia a, T. Perko c, A. Rosi a, F. Rollinger d, S. Salomaa e, L. Sirkka e, M.A. Tabocchini a, C. Turcanu c, M. Grigioni a. a Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma, Italy; b Centre for Radiation, Chemical and Environmental Hazards, Public Health England, Didcot, UK; c SCK CEN Belgian Nuclear Research Centre, Mol, Belgium; d Institut de Radioprotection e de Surete Nucleaire, Fontenay-aux-Roses, France; e STUK – Radiation and Nuclear Safety Authority, Helsinki, Finland Introduction: The EC OPERRA project (Open Project for the European Radiation Research Area) aims to create an innovative mechanism for the implementation of an instrument of joint programming that can be applied to all fields of research in radiation protection. In particular, the Task Group (TG) 4.3 aims to identify national and international stakeholders and to collect and analyse their opinions on research priorities in radiation protection. Within this TG, the ISS (TG 4.3.2 leader) has coordinated the creation of a survey in electronic format. Materials and Methods: The survey has been developed by the tool ZEF Evaluation Engine. Data analysis was performed by using ZEF, EXCEL and SPSS software. The questionnaire was organised with an initial section containing the synergistic priorities common to the European platforms MELODI, ALLIANCE, NERIS and EURADOS. The next four sections contained questions extracted respectively from each platform Strategic Research Agenda. Finally, other sections were devoted to issues related to ethical aspects of radiation protection, risk communication and risk perception, and education and training. Stakeholders to which the survey should be sent were identified from contact lists provided by the four platforms and by contacting the presidents of international scientific associations, the representatives of international organisations, etc. Each of them has been asked to spread the survey link to their members and/or advertise on their websites.
e121
Results and Conclusion: In the present work, some key results related to the synergistic priorities will be shown and discussed. The importance/ feasibility ranking was used for gathering opinion on these topics. Most responses came from those with interests in low dose risk and dosimetry. A complete analysis of the results is available on MELODI website (http://www.melodi-online.eu). A selection of such synergistic topics was recommended as the focus of the second OPERRA call for research proposals. http://dx.doi.org/10.1016/j.ejmp.2016.01.418 D.412 QUALITY ASSURANCE AND MANAGEMENT PROGRAM OF INDIVIDUAL AND ENVIRONMENTAL RADIATION PROTECTION EQUIPMENT IN A ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM M. Paolucci *, R. Di Lorenzo, A. Didona. USL Umbria 2 – Servizio Di Fisica Medica, Foligno, Italy Purpose: USL 2 Umbria was born in 2013 by merging 2 health care institutions; it’s organized into 6 districts and 8 regional hospitals, where the Medical Physics Department started a Quality Assurance (QA) and management system of Personal Protective Equipment (PPE) and mobile radiation shields, by placing them in the ISO 9001: 2008 Quality Management System. Materials and Methods: A multidisciplinary workgroup, including the Department of Diagnostic Imaging and Therapeutics and all departments and structures where radiation sources are used, was created. We started with census and efficiency check of all the equipment, through a dedicated QA program on all USL 2 Umbria radiological sites, in collaboration with technician staff. Subsequently a protocol for periodic functional and quality tests and a management procedure were established and a list with minimum necessary equipment for each radiological site was prescribed. Results: The Quality Management System was implemented over a period of about two years, establishing a management and monitoring paperwork, a program of audits and periodic QA tests on all the equipment, in order to ensure their correct efficiency, in compliance with regulatory requirements. During the QA campaign 483 PPE were tested, 5% of which was replaced with new equipment as resulted not suitable. We also disposed of 46 PPE unused because clearly damaged, following an internal procedure according to Italian legislation D. Lgs. 152/06. Furthermore a routine sanitization procedure for each PPE was established for their correct maintenance and conservation. Conclusion: The results led to an optimization of the equipment distribution, highlighting the need of continuous checks in order to provide a proper protection against ionizing radiation during clinical activities for patients and operators. http://dx.doi.org/10.1016/j.ejmp.2016.01.419 D.413 ISO 17025 ACCREDITATION EXPERIENCE OF AN INDIVIDUAL MONITORING SERVICE F. Rossi *, L. Fedeli, L. Noferini, M. Fedi, A. Falivene. Fisica Sanitaria AOU Careggi, Firenze, Italy Introduction: The European directives, according to ICRP recommendations, state that for people occupationally exposed to ionizing radiation a monitoring of absorbed dose is needed, the measuring instrument is called dosimeter. A service, called IMS (Individual Monitoring Service), is thus needed, providing not only the instruments but also calibrations, traceability of the name of worker related to dosimeter ID, proper storage of dose data, and so on. The Directive states that each member State shall develop approval procedures to state whether an IMS is or not suitable for its purpose. Italy is actually without any kind of approval procedure. Furthermore, the EC document RP160 states guidelines for IMSs, requiring compliance to ISO 17025 standard to fulfill adequate quality levels. Materials and Methods: Our IMS was updated to make it compliant with ISO 17025 standard. This involved: instrument maintenance, human resource proper training, operative procedures, traceability, calibrations, software, data recording and dose reporting. The updating was very timeconsuming, involving six persons two of them medical physicists.