The International Atomic Energy Agency (IAEA) developed a comprehensive program—Quality Management Audits in Nuclear Medicine (QUANUM). This program covers all aspects of nuclear medicine practices ...including, but not limited to, clinical practice, management, operations, and services. The QUANUM program, which includes quality standards detailed in relevant checklists, aims at introducing a culture of comprehensive quality audit processes that are patient oriented, systematic, and outcome based. This paper will focus on the impact of the implementation of QUANUM on daily routine practices in audited centers. Thirty-seven centers, which had been externally audited by experts under IAEA auspices at least 1 year earlier, were invited to run an internal audit using the QUANUM checklists. The external audits also served as training in quality management and the use of QUANUM for the local teams, which were responsible of conducting the internal audits. Twenty-five out of the 37 centers provided their internal audit report, which was compared with the previous external audit. The program requires that auditors score each requirement within the QUANUM checklists on a scale of 0-4, where 0-2 means nonconformance and 3-4 means conformance to international regulations and standards on which QUANUM is based. Our analysis covering both general and clinical areas assessed changes on the conformance status on a binary manner and the level of conformance scores. Statistical analysis was performed using nonparametric statistical tests. The evaluation of the general checklists showed a global improvement on both the status and the levels of conformances (P < 0.01). The evaluation of the requirements by checklist also showed a significant improvement in all, with the exception of Hormones and Tumor marker determinations, where changes were not significant. Of the 25 evaluated institutions, 88% (22 of 25) and 92% (23 of 25) improved their status and levels of conformance, respectively. Fifty-five requirements, on average, increased from nonconformance to conformance status. In 8 key areas, the number of improved requirements was well above the average: Administration & Management (checklist 2); Radiation Protection & Safety (checklist 4); General Quality Assurance system (checklist 6); Imaging Equipment Quality Assurance or Quality Control (checklist 7); General Diagnostic (checklist 9); General Therapeutic (checklist 12); Radiopharmacy Level 1 (checklist 14); and Radiopharmacy Level 2 (checklist 15). Analysis of results related to clinical activities showed an overall positive impact on both the status and the level of conformance to international standards. Similar results were obtained for the most frequently performed clinical imaging and therapeutic procedures. Our study shows that the implementation of a comprehensive quality management system through the IAEA QUANUM program has a positive impact on nuclear medicine practices.
An effective management system that integrates quality management is essential for a modern nuclear medicine practice. The Nuclear Medicine and Diagnostic Imaging Section of the International Atomic ...Energy Agency (IAEA) has the mission of supporting nuclear medicine practice in low- and middle-income countries and of helping them introduce it in their health-care system, when not yet present. The experience gathered over several years has shown diversified levels of development and varying degrees of quality of practice, among others because of limited professional networking and limited or no opportunities for exchange of experiences. Those findings triggered the development of a program named Quality Management Audits in Nuclear Medicine (QUANUM), aimed at improving the standards of NM practice in low- and middle-income countries to internationally accepted standards through the introduction of a culture of quality management and systematic auditing programs. QUANUM takes into account the diversity of nuclear medicine services around the world and multidisciplinary contributions to the practice. Those contributions include clinical, technical, radiopharmaceutical, and medical physics procedures. Aspects of radiation safety and patient protection are also integral to the process. Such an approach ensures consistency in providing safe services of superior quality to patients. The level of conformance is assessed using standards based on publications of the IAEA and the International Commission on Radiological Protection, and guidelines from scientific societies such as Society of Nuclear Medicine and Molecular Imaging (SNMMI) and European Association of Nuclear Medicine (EANM). Following QUANUM guidelines and by means of a specific assessment tool developed by the IAEA, auditors, both internal and external, will be able to evaluate the level of conformance. Nonconformances will then be prioritized and recommendations will be provided during an exit briefing. The same tool could then be applied to assess any improvement after corrective actions are taken. This is the first comprehensive audit program in nuclear medicine that helps evaluate managerial aspects, safety of patients and workers, clinical practice, and radiopharmacy, and, above all, keeps them under control all together, with the intention of continuous improvement.
The International Atomic Energy Agency has developed a program, named Quality Management Audits in Nuclear Medicine (QUANUM), to help its Member States to check the status of their nuclear medicine ...practices and their adherence to international reference standards, covering all aspects of nuclear medicine, including quality assurance/quality control of instrumentation, radiopharmacy (further subdivided into levels 1, 2, and 3, according to complexity of work), radiation safety, clinical applications, as well as managerial aspects. The QUANUM program is based on both internal and external audits and, with specifically developed Excel spreadsheets, it helps assess the level of conformance (LoC) to those previously defined quality standards. According to their level of implementation, the level of conformance to requested standards; 0 (absent) up to 4 (full conformance). Items scored 0, 1, and 2 are considered non-conformance; items scored 3 and 4 are considered conformance. To assess results of the audit missions performed worldwide over the last 8 years, a retrospective analysis has been run on reports from a total of 42 audit missions in 39 centers, three of which had been re-audited. The analysis of all audit reports has shown an overall LoC of 73.9 ± 8.3% (mean ± standard deviation), ranging between 56.6% and 87.9%. The highest LoC has been found in the area of clinical services (83.7% for imaging and 87.9% for therapy), whereas the lowest levels have been found for Radiopharmacy Level 2 (56.6%); Computer Systems and Data Handling (66.6%); and Evaluation of the Quality Management System (67.6%). Prioritization of non-conformances produced a total of 1687 recommendations in the final audit report. Depending on the impact on safety and daily clinical activities, they were further classified as critical (requiring immediate action; n = 276; 16% of the total); major (requiring action in relatively short time, typically from 3 to 6 months; n = 604; 36%); whereas the remaining 807 (48%) were classified as minor, that is, to be addressed whenever possible. The greatest proportion of recommendations has been found in the category “Managerial, Organization and Documentation” (26%); “Staff Radiation Protection and Safety” (17.3%); “Radiopharmaceuticals Preparation, Dispensing and Handling” (15.8%); and “Quality Assurance/Quality Control” and “Management of Equipment and Software” (11.4%). The lowest level of recommendations belongs to the item “Human Resources” (4%). The QUANUM program proved applicable to a wide variety of institutions, from small practices to larger centers with PET/CT and cyclotrons. Clinical services rendered to patients showed a good compliance with international standards, whereas issues related to radiation protection of both staff and patients will require a higher degree of attention. This is a relevant feedback for the International Atomic Energy Agency with regard to the effective translation of safety recommendations into routine practice. Training on drafting and application of standard operating procedures should also be considered a priority.
Typically hyperthyroidism has been more often associated with the female gender. There is a large female predilection (male:female sex ratio up to 1:10), with little documentation in the literature ...about wholly male hyperthyroid populations. A male incidence of 0.7 per 100, 000 has been reported for South African men while the women have a relatively higher rate of 0.02. There is no documented evidence between male and female genders in response to treatment of PH with radioactive iodine (RAI), although operational evidence suggests that hyperthyroidism in males is less amenable to RAI treatment (RAIT) than females. This study therefore proposed to evaluate male hyperthyroid patients with Graves' disease (GD) treated at our facility, for factors affecting outcome of RAIT.
This is a retrospective analysis of records of hyperthyroid patients who were treated with RAI over a 19-year period at a university teaching hospital, in the Western Cape of South Africa.
The overall cure rate was 76.4% for these male patients. Cure was observed as euthyroidism in 31 patients (15.3%) and hypothyroidism in 129 (63.5%). Age, thyroid uptake, severity of hyperthyroidism, previous antithyroid drug (ATD) usage, administered quantity of RAI, ethnicity and patients' pulse at presentation were not significant in influencing outcome.
Factors which have been evaluated as affecting outcome of RAIT were unimportant in these patients. Despite the mainly hyperthyroid presentation of the patients, RAIT was so effective that the main type of cure after therapy was hypothyroidism.
Background
In 2005, 80% of cardiovascular disease (CVD) deaths occurred in low- to middle-income countries (i.e., developing nations). Cardiovascular imaging, such as myocardial perfusion SPECT, is ...one method that may be applied to detect and foster improved detection of at-risk patients. This document will review the availability and utilization for nuclear cardiology procedures worldwide and propose strategies to devise regional centers of excellence to achieve quality imaging around the world.
Methods
As a means to establish the current state of nuclear cardiology, International Atomic Energy Agency member and non-member states were queried as to annual utilization of nuclear cardiology procedures. Other sources for imaging statistics included data from medical societies (American Society of Nuclear Cardiology, European Society of Cardiology, and the European Association of Nuclear Medicine) and nuclear cardiology working groups within several nations. Utilization was calculated by dividing annual procedural volume by 2007 population statistics (/100,000) and categorized as high (>1,000/100,000), moderate-high (250-999/100,000), moderate (100-249/100,000), low-moderate (50-99/100,000) and low (<50/100,000).
Results
High nuclear cardiology utilization was reported in the United States, Canada, and Israel. Most Western European countries, Australia, and Japan reported moderate-high utilization. With the exception of Argentina, Brazil, Colombia and Uruguay, South America had low usage. This was also noted across Eastern Europe, Russia, and Asia. Utilization patterns generally mirrored each country’s gross domestic product. However, nuclear cardiology utilization was higher for developing countries neighboring moderate-high “user” countries (e.g., Algeria and Egypt); perhaps the result of accessible high-quality training programs.
Conclusions
Worldwide utilization patterns for nuclear cardiology vary substantially and may be influenced by physician access to training and education programs. Development of regional training centers of excellence can guide utilization of nuclear cardiology through the application of guideline- and appropriateness-driven testing, training, continuing education, and quality assurance programs aiding developing nations to confront the epidemics of CVD.
A normal Tc-99m MIBI myocardial perfusion study has previously been shown to indicate a benign prognosis. Our aim was to determine the longer term prognosis of a normal study in our patient ...population. Methods: A retrospective evaluation of 209 patients with a normal Tc-99m MIBI study was performed. Follow-up data was obtained in 157 patients, with complete follow-up in 121 (mean follow-up period of 56 months). In 36 patients only partial follow-up was possible (32 months follow-up). No follow-up data, except for the possible registration of deaths, could be obtained in 52. Patients were evaluated for the occurrence of primary or secondary cardiac events. Results: The study group had a moderate pre-test probability for coronary artery disease (48 + 30.7%). Two possible cardiac deaths occurred (cardiac death rate of 0.95%). No primary events occurred in the group with complete follow-up, but 6 secondary events were recorded (cardiac event rate of 4.9%). No primary or secondary events occurred in the partial follow-up group during the follow-up period. The incidence of secondary or non-fatal primary events in this group for the period after they were lost to follow-up or in the group with no follow-up could not be ascertained. There was, however, no statistically significant difference between these groups regarding age, pre-test probability and exercise parameters. Conclusion: Similar to the findings with Tl-201, our study indicates a favourable longer term prognosis after a normal Tc-99m MIBI study.
Abstract The significance of FDG PET in the interim follow-up of patients with diffuse large B-cell lymphoma to evaluate therapy response is currently being debated. Reports with discordant results ...have been published. Several authors have reported a low positive predictive value when using FDG PET to evaluate interim therapy response. Different criteria for the interpretation of PET studies in these patients are available, producing variable results. The latest publications and the review criteria will be summarised in this paper.
FIGO (International Federation of Gynaecology and Obstetrics) staging is currently the most widely used clinical staging system for cervical cancer; however, this staging system has many ...shortcomings. One of these shortcomings is that lymph nodal status, specifically the para-aortic lymph nodal status, does not get taken into account. It is known that metabolic changes occur before changes are seen on anatomical imaging, and it is therefore possible to detect metastases earlier with the help of fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT). We hypothesized that by including an FDG PET/CT study as part of the staging investigations in patients with invasive cervical cancer, pretreatment staging would improve and management would change in a significant proportion of patients.
Patients diagnosed with FIGO stage IIIB cervical cancer from September 2010 to December 2015 received an FDG PET/CT study as part of their staging workup. A whole-body FDG PET/CT was performed before initiation of treatment, and the results were interpreted by experienced nuclear medicine physicians and radiologists. We determined the percentage of patients in whom PET/CT changed the stage and/or altered management of the patient.
There were 95 patients diagnosed with stage IIIB cervix cancer during the study period who received an FDG PET/CT as part of their staging workup. Eighty-eight patients were included in the final sample. Positron emission tomography/CT affected the management of 40% of patients, with 19% requiring a change in the radiation field due to identification of para-aortic nodal involvement and 21% upstaged to stage IVB.
Fluorodeoxyglucose PET/CT is useful in assessing distant disease and evaluating nodal involvement in patients with invasive cervical cancer. Additional findings on the PET/CT that were missed by conventional imaging and clinical examination caused treatment change in a significant proportion of patients.