The importance of quality management systems in nuclear medicine departments.

Quality management systems (QMS) in nuclear medicine is an essential component of the Quality program and is instrumental in the safe delivery of a high standard clinical service. The IAEA QUANUM program is a nuclear medicine specific audit program that can be used to assess the standards of a nuclear medicine department and its service delivery. Regular internal and external audits are encouraged as part of the QMS.

The consequences of COVID-19 pandemic in the routine of Nuclear Medicine Departments.

The outbreak and spreading of the COVID-19 pandemic have affected billions of people around the world, severely disrupting many aspects of their lives. Although not at the frontline of the pandemic response, Nuclear Medicine departments have to adopt their clinical routine to the new environment. A series of protective measures, including among others spatial arrangements to promote social distancing, meticulous hand hygiene and use of personal protective equipment, workload reduction, patient screening at admission and examination protocol adjustments, have to be adopted in order to minimize the risk of spreading the infection and ensure the safety of both their patients and staff. As the pandemic seems to slowly recede, the valuable experience gained should help everyone be much better prepared for a possible new outbreak.

Nuclear Cardiology practice in COVID-19 era.

The Coronavirus Disease 2019 (COVID-19) pandemic is the biggest shock in decades to the well developed healthcare system and resources worldwide. Although there was a wide variation in the level of preparedness, the transition was tough even for the most renowned healthcare systems. Increasing the capacity and adapting healthcare for the needs of COVID-19 patients is described by the WHO as a fundamental outbreak response measure. However, while the system is preoccupied with a pandemic infection, patients suffering from other illnesses are in high risk to get infected, also being compromised by the imperative shift in medical resources and significant restrictions on routine medical care. For example patients with cardiovascular disease and others referred for nuclear cardiology procedures are frequently greater than 60 years of age and have other comorbidities (e.g. hypertension, diabetes, chronic lung disease, and chronic renal disease) that place them at a high-risk for adverse outcomes with COVID-19, providing unique challenges for their management in healthcare facilities, as well as for the care of health care personnel. Numerous medical specialty societies and governmental agencies issued guidelines aiming at the specification of preventive measures and amendments in everyday clinical practice during the escalation and peak of the pandemic. In accordance, the American Society of Nuclear Cardiology (ASNC) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI), issued a common statement in late March 2020, which was provided as an initial response to this pandemic, offering specific recommendations for adapting nuclear cardiology practices at each step in a patient's journey through the lab-for inpatients, outpatients and emergency department patients. One of the main recommendations was cancelling or delaying of all non-urgent nuclear cardiology studies. As COVID-19 follows a different time course in different geographic regions and lockdowns begin to lift in many countries, the issue of re-establishment of non-emergent care, in nuclear cardiology laboratories amongst others, has to be addressed in a watchful and balanced way, keeping in mind that the COVID-19 crisis is far from over. Furthermore measuring what is happening in the current crisis is essential to ensuring preparedness for a possible next wave of the pandemic. Recently the ASNC, SNMMI, the International Atomic Energy Agency (IAEA) and the Infectious Disease Society of America (IDSA), issued an information statement which describes a careful approach to reestablishment of non-emergent care in nuclear cardiology laboratories reflecting diverse settings from the United States and worldwide. In the same spirit it is also the reintroduction guidance issued by North American Cardiovascular Societies. In this paper we provide a synopsis of the basic steps of adapting nuclear cardiology practice in the era of COVID-19 in order to balance between the risk of viral transmission while also providing crucial cardiovascular assessments for our patients.

COVID-19 pandemic: Implications for radionuclide therapy in Nuclear Medicine departments.

The global COVID-19 health and economic crisis has forced people to adopt challenging rules of social distancing and self-isolation. Health care staff has been advised to change working routines to keep themselves and their patients safe. Radionuclide therapy has had an increasing role in clinical practice. Most therapeutic radionuclide procedures have applications in oncology. Cancer patients are an especially fragile and vulnerable population with higher risk due to co morbidities and immunosuppression. COVID-19 is another risk that must be considered in treatment planning. Therapeutic, prophylactic, and supportive interventions may require changes for these patients. The most common radionuclide therapies involve patients with differentiated thyroid cancer (DTC) who need radioiodine therapy (RAI), patients with neuroendocrine tumours (NETs) who need peptide receptor radionuclide therapy (PRRT), patients with hepatocellular carcinoma (HCC) who need therapy with radiolabelled microspheres, and patients with prostate cancer and bone metastasis who need radionuclide palliative therapy. If infected, cancer patients could be at a higher risk for serious COVID-19 disease. Treatment decisions for thyroid cancer and NETs are challenging in this environment. Any decision to postpone therapy must be carefully considered, balancing risks and benefits. A risk of worsened prognosis due to delayed or suboptimal cancer treatment must be weighed against the risk of severe COVID-19 illness.

Nuclear Medicine and Oncology in the COVID-19 pandemic era.

The coronavirus disease 2019 (COVID-19) global pandemic poses a significant challenge to the national health systems. Not only China, the first country that experienced the health crisis since last December, but the rest of the world, is facing an unprecedented global health crisis, the most serious crisis in a century, with social and economic impact. However, the most important impact of the new pandemic is the human impact. Till 4th of June 2020, coronavirus SARS-CoV-2, causing COVID-19 disease, has infected more than 65000.000 people and has been responsible for more than 386000 deaths globally. The first priority of public health authorities is to contain and mitigate the spread and infection rate of the coronavirus SARS-CoV-2, distributing the number of infections over time and, if possible, reduce the incidence of the disease (COVID-19) it causes. A critical task for health systems confronted with the spread of the coronavirus is to protect the health of all citizens, so this requires that both diagnosis/testing and appropriate care should be readily available, affordable, and provided in a safe environment. The health care systems of many developed countries failed to demonstrate a satisfactory response to the increased demand for acute care hospital beds, ventilators, emergency services, diagnostics tests, support equipment for their COVID-19 patients, availability of essential medicines, protective equipment for their staff etc. Nuclear Medicine (NM) departments and their staff, in spite of the fact that not being in the front line of the pandemic response, have experienced a dramatic alteration in their daily clinical activity, trying to adapt their clinical routine to the new environment. There are several issued guidance from national and international organizations, trying to help to cope with suspected or verified COVID-19 patients. Patients with cancer are thought to be more susceptible and have higher morbidity and mortality rates from COVID-19 than the general population. In the current article, our aim is to present measures, guidance and thoughts that should be considered for the cancer patients.

Challenges and priorities in skeletal, gastrointestinal, hepatobiliary, genitourinary and lung scintigraphy during the COVID-19 pandemic.

On December 29, 2019, a hospital in the City of Wuhan, Hubei Province, in Central China, admitted four individuals with pneumonia. The hospital reported this occurrence to the local center for disease control (CDC), which lead Wuhan CDC staff to initiate a field investigation with a retrospective search for pneumonia patients. On December 31, 2019, the World Health Organization (WHO) was alerted by the Chinese authorities for several cases of pneumonia of unknown origin in the City of Wuhan. On January 7, 2020, a novel virus was identified as the causative agent, belonging to the Coronaviridae family (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2). Within the same month, the virus spread to other provinces of China, as well as a number of neighbouring countries. On February 11, 2020, the WHO announced that the SARS-CoV-2 - caused infection would be called coronavirus disease 2019 (COVID-19). On February 15, 2020, the first death due to COVID-19 in Europe was reported; a Chinese tourist who died in France. The first COVID-19 case was diagnosed in Greece on February 26th. The WHO declared COVID-19 a pandemic on 11 March 2020. On March 12th, movie theaters, gyms and courtrooms were closed in Greece and on March 13th, with 190 confirmed cases and 1 death, malls, cafés, restaurants, bars, beauty parlors, museums and archaeological sites were also closed. So far, COVID-19 pandemic has affected the way people live and work globally, and has resulted in extreme strain on the healthcare systems worldwide. Most of the nuclear medicine studies are performed on an out-patient basis. Therefore, without effective implementation of the required preventive measures, there is a significant risk for viral transmission when visiting nuclear medicine departments, particularly in periods of high community spread.

Nuclear thyroidology in pandemic times: The paradigm shift of COVID-19.

Since its outbreak in Wuhan, China the SARS-CoV-2 has become a public health emergency of international concern, impacting all areas of daily life, including medical care. Although not in the front line nuclear medicine practice should adjust their standard operating procedures. The adaptations and the flexibility that nuclear thyroidology, among other fields of nuclear medicine, should show during the pandemic, must focus not only in minimizing the risk of infection to staff, patients, and family members, but also in controlling the transmission of the virus while continuing to provide health care services which do not jeopardize patients' prognosis and quality of life. Favorable prognosis and indolent symptoms of most cases of thyroid diseases, allows postponements and rescheduling as well as alternative procedures, provided that they are cautiously considered for each case individually. The objective of the current paper is to provide guidance on how diagnostic and therapeutic management of patients with thyroid diseases can be safely and effectively adjusted during pandemic, in nuclear medicine settings.

Non-Oncological PET/CT imaging during SARS-CoV-2 pandemic.

In December 2019 a new ß-CoV, Severe Acute Respiratory Coronavirus- 2 (SARS-CoV-2), has been identified in Wuhan Hubei Province, China. Within a few months it spread rapidly to more than 114 countries and the disease, Coronavirus disease 2019 (COVID-19), was declared pandemic on 11th February 2020 by the World Health Organization (WHO). Until 20 June 2020 8:09 am, 8,465,085 cases of COVID-19 were confirmed globally, with 454,258 deaths. The first incidence in Greece was documented on 26 February 2020 in Thessaloniki and up to 20 June 2020 8:09 am, 3,227 confirmed cases of COVID-19 were reported, with 188 deaths. At the time of writing USA and Brazil, are the countries with the highest disease burden. Governments have imposed a variety of suggestions and restrictions in order to control the spread of the virus, focusing mainly on social distancing, self-isolation, personal hygiene and personal protective equipment (PPE). Greece was one of the countries that implemented early drastic measures thus succeeding in controlling the virus transmission; having a profound economical effect though.

Herramienta basada en código abierto para el cálculo de blindaje en las instalaciones de Medicina Nuclear / Open Source Based Tool for Shielding Calculation in Nuclear Medicine Installations

Uno de los requerimientos indispensables en el diseño de las instalaciones donde se trabaja con radiación ionizante es la determinación del espesor adecuado de las paredes, pisos, techo y puertas de los locales, que garanticen dosis por debajo de las restricciones establecidas por la autoridad regulatoria. El objetivo del presente trabajo es desarrollar una herramienta interactiva, libre y de código abierto para calcular los blindajes requeridos en una instalación de Medicina Nuclear. En el código, desarrollado en Phyton utilizando el entorno interactivo Jupiter Notebook, se incluyó el análisis tanto para Tomografía por Emisión de Fotón Único como para Tomografía por Emisión de Positrones. La herramienta fue implementada para el cálculo de los blindajes de un departamento de Medicina Nuclear del Centro Internacional de Restauración Neurológica (CIREN). Esta herramienta libre y de código abierto facilita los cálculos de blindaje aumentando la velocidad, lo que contribuye a lograr una optimización de la protección radiológica, pero también puede usarse como herramienta pedagógica(AU)

One of the indispensable requirements in the design of the facilities where ionizing radiation is used is the determination of the adequate thickness of the walls, floors, ceiling and doors of the premises, which guarantee doses below the restrictions established by the regulatory authority. The goal of this work is to develop an interactive, free and open source tool to calculate the shields required in a Nuclear Medicine installation. Analysis for both Single Photon Emission Tomography and Positron Emission Tomography was included in the code, developed in Phyton using the interactive Jupiter Notebook environment. The tool was implemented to calculate the shields of a Nuclear Medicine department of the International Center for Neurological Restoration (CIREN). This free and open source tool facilitates shielding calculations by increasing speed, which contributes to the optimization of radiation protection, but can also be used as a pedagogical tool(AU)

An IAEA survey of radiotherapy practice including quality assurance extent and depth.

Background: The IAEA recommends a quality assurance program in radiotherapy to ensure safe and effective treatments. In this study, radiotherapy departments were surveyed on their current practice including the extent and depth of quality assurance activities.Methods: Radiotherapy departments were voluntarily surveyed in three stages, firstly, in basic facility information, secondly, in quality assurance activities and treatment techniques, and thirdly, in a snapshot of quality assurance, departmental and treatment activities.Results: The IAEA received completed surveys from 381 radiotherapy departments throughout the world with 100 radiotherapy departments completing all three surveys. Dominant patterns were found in linac-based radiotherapy with access to treatment planning systems for 3D-CRT and 3D imaging. Staffing levels for major staff groups were on average in the range recommended by the IAEA. The modal patient workload per EBRT unit was as expected in the range of 21-30 patients per day, however significant instances of high workload (more than 50 patients per day per treatment unit) were reported. Staffing levels were found to correlate with amount of treatment equipment and patient workload. In a self-assessment of quality assurance performance, most radiotherapy departments reported that they would perform at least 60% of the quality assurance activities itemized in the second survey, with particular strength in equipment quality control. In a snapshot survey of quality assurance performance, again equipment quality control practice was well developed, particularly for the treatment equipment.Conclusions: The IAEA surveys provide a snapshot of current radiotherapy practice including quality assurance activities.

123I intercomparison exercises: Assessment of measurement capabilities in UK hospitals.

Three comparison exercises have been performed in 1996, 1999 and 2015 with 123I to assess the UK hospitals measurement capabilities using radionuclide calibrators for this particular radionuclide. The exercise performed in 1996 showed that only 62% of the participants could measure the solution to within 10% of the standardised value and only 28% could measure within 5% of the certificated value. The intercomparison exercise performed in 1999 showed no improvement in the measurement capability, with only 66% of the participants measuring to within 10% of the standardised value. The exercise performed in 2015 showed great improvement in the hospitals measurement capability, 94% of participants reported results within 10% of the certificated activity and 85% of the participants reported results within the 5% of the reported activity. The intercomparison exercises are an important way to identify possible measurement problems within the medical community. Additionally, the intercomparison exercises provide hospitals with traceability to national primary standards and improve measurement capability within the Nuclear Medicine community.

A Novel 141Ce-Based Flood Field Phantom: Assessment of Suitability for Daily Uniformity Testing in a Clinical Nuclear Medicine Department.

Daily quality control testing of a γ-camera is of the utmost importance in assessing whether the camera is suitable for clinical use. The aim of our study was to assess the suitability of a fillable 141Ce-based flood field phantom developed in-house for daily quality control testing of γ-cameras. Methods: Daily uniformity testing was performed for 113 d using the fillable 141Ce phantom and a commercially available sheet-type 57Co phantom, and the results were compared. Results: The average integral uniformity obtained by the 141Ce and 57Co phantoms was 3.24% and 2.72%, respectively, for detector 1 and 3.31% and 2.78%, respectively, for detector 2. Conclusion: The 141Ce phantom we developed is a suitable alternative to the commercially available 57Co phantom.

Analysis of non-conformity in continuous quality improvement in a Hospital Radiopharmacy Unit.

AIM: To perform an analysis of non-conformities (NC) registered between 2012 and 2015, as a part of the review process of the Quality Management System of our Radiopharmacy Unit. MATERIAL AND METHODS: Non-conformities registered in the Radiopharmacy Unit in the period 2012-2015 are analyzed and sorted by their impact on the process (critical, major, and minor), cause/origin of the non-conformity, and nature of radiopharmaceutical (PET vs. SPECT). RESULTS: A decrease in the NC of 20% per year is observed, especially in PET radiopharmaceuticals. Non-conformities in SPECT make up about 62-84% of the total of the NC, mainly related to the high number of doses prepared and not administered, which is about 1.5-3% in the ratio of non-administered/administered per year. CONCLUSIONS: Analysis of the NC can be considered as a useful indicator in assessment of quality assurance, and in our particular case, the decrease in the registration of NC indicates effectiveness in the corrective and preventive actions implemented.

First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit.

BACKGROUND: According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). METHODS: The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. RESULTS: The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. CONCLUSIONS: The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.

[Personalizing the reference level: gold standard to evaluate the quality of service perceived]. / Personalización del nivel de referencia: patrón oro para evaluar la calidad de servicio percibida.

OBJECTIVE: To know the cutoff point at which in-house Nuclear Medicine Department (MND) customers consider that the quality of service is good (personalized cutoff). MATERIAL AND METHOD: We conducted a survey of the professionals who had requested at least 5 tests to the Nuclear Medicine Department. A total of 71 doctors responded (response rate: 30%). A question was added to the questionnaire for the user to establish a cutoff point for which they would consider the quality of service as good. The quality non-conformities, areas of improvement and strong points of the six questions measuring the quality of service (Likert scale 0 to 10) were compared with two different thresholds: personalized cutoff and one proposed by the service itself a priori. Test statistics: binomial and Student's t-test for paired data. RESULTS: A cutoff value of 7 was proposed by the service as a reference while 68.1% of respondents suggested a cutoff above 7 points (mean 7.9 points). The 6 elements of perceived quality were considered strong points with the cutoff proposed by the MND, while there were 3 detected with the personalized threshold. Thirteen percent of the answers were nonconformities with the service cutoff versus 19.2% with the personalized one, the differences being statistically significant (difference 95% CI 6.44%:0,83-12.06). CONCLUSIONS: The final image of the perceived quality of an in-house customer is different when using the cutoff established by the Department versus the personalized cutoff given by the respondent.

[Evaluating radiation dose load in medical personnel of radiologic diagnostic departments].

The article deals with materials on radiation hygienic evaluation of radiologic diagnostic departments in various medical institutions of Moscow. The studies covered work of medical staffers in X-ray examination and in contact with short-lived isotope generators. The authors outlined the examination types and stages with maximal radiation danger. Disimetric information obtained during the study helped to calculate values of equivalent, effective doses of radiation for medical personnel and maximal potential doses.

Radiation doses of employees of a Nuclear Medicine Department after implementation of more rigorous radiation protection methods.

The appropriate radiation protection measures applied in departments of nuclear medicine should lead to a reduction in doses received by the employees. During 1991-2007, at the Department of Nuclear Medicine of Pomeranian Medical University (Szczecin, Poland), nurses received on average two-times higher (4.6 mSv) annual doses to the whole body than those received by radiopharmacy technicians. The purpose of this work was to examine whether implementation of changes in the radiation protection protocol will considerably influence the reduction in whole-body doses received by the staff that are the most exposed. A reduction in nurses' exposure by ~63 % took place in 2008-11, whereas the exposure of radiopharmacy technicians grew by no more than 22 % in comparison with that in the period 1991-2007. Proper reorganisation of the work in departments of nuclear medicine can considerably affect dose reduction and bring about equal distribution of the exposure.

[(No) Fear of audits? Control is good, trust is better. Audits as a core element of quality management]. / (K)eine Angst vor Audits? Kontrolle ist gut, Vertrauen ist besser. Audits als zentrales Qualitätsmanagementelement richtig anwenden.

Quality management (QM) cannot be successfully implemented and performed without audits. The PDCA (Plan-Do-Check-Act) cycle is the core component of QM systems. In this cycle an audit represents the crucial step "check". Audits verify whether the performed actions and their results conform to the requirements. It is especially important to verify whether the principles of QM are omnipresent and fully implemented in a department or institution. The announcement of an audit may cause mixed feelings or even anxiety among the personnel to be audited. Without previous information and training the audit may be perceived as an act of control and intrusion into departmental affairs. The colleagues often fear sanctions if lapses are found or consider the audit to be a cross-examination. However, an audit is rather meant to be a helpful aid and a chance to continuously improve the departmental QM system by means of a constructive communication among colleagues. In the year 2009 the European Commission published guidelines for the performance of clinical audits in medical radiology, including diagnostic radiology, nuclear medicine and radiation therapy (Council Directive 97 / 43 / EURATOM). The aim is an optimal protection of the individual from the hazards of ionizing radiation and the directive expects radiological departments to perform clinical audits in accordance with national procedures.