The IAEA QUANUM program: a practical tool for quality audits in Nuclear Medicine

Introduction: The International Atomic Energy Agency (IAEA) has developed over the last 15 years an auditing program—Quality Management Audits in Nuclear Medicine (QUANUM) —covering all aspects of nuclear medicine practices including, but not limited to, clinical practice, management, operations, and radiation safety and protection. The QUANUM programme has proven to be applicable to many nuclear medicine services across a variety of economic circumstances and is aimed at assessing practices' compliance to standards based on publications of the IAEA, the International Commission on Radiological Protection (ICRP), and guidelines from all relevant scientific societies. By means of a specific Excel tool developed by the IAEA, the auditors, both internal and external, will be able to evaluate the level of conformance. The latest updated revision, QUANUM 3.0, published in June 2021, follows the principle of continuous improvement in quality and was completed in 2019 and considers the release of new General Safety Requirements by the IAEA, including the new Basic Safety Standards and also reflects new scientific developments and lessons learned in more than a decade of global implementation and use of QUANUM.

Methods: Seventy-three nuclear medicine centres in 46 countries had been externally audited by a multidisciplinary team of experts under IAEA auspices. Audit teams are multidisciplinary and typically comprise of a nuclear medicine physician, a radiopharmacist, a medical physicist, a technologist and a staff member of the Nuclear Medicine and Diagnostic Imaging Section of the IAEA, all of them with competences as quality auditors. The present study reports the outcome analysis of the impact of the QUANUM program on quality of practice in a group of audited centers. A follow-up internal audit was carried out using the QUANUM checklists. The results of the external and internal audits were compared to evaluate if the corrective actions, recommended during the external audit were implemented.

Results: Twenty-five out of the 73 centers provided their internal audit report, which was compared with the previous external audit. The evaluation of the general checklists showed a global improvement on both the status and the levels of conformances (P&thinsp;<&thinsp;0.01). Twenty-two (88%) and 23 (92%) of these 25 centers improved their status and levels of conformance, respectively. Fifty-five requirements, on average, increased from nonconformance to conformance status. Similar results were obtained for the most frequently performed clinical imaging and therapeutic procedures.

Conclusions: Our study shows that the implementation of a comprehensive quality management system through the IAEA QUANUM program had an overall positive impact on both the status and the level of conformance to international standards in nuclear medicine practices.