Evaluation of professional practices in hospital radiopharmacy using a process-based clinical audit: a quality improvement study

OBJECTIVES: Hospital radiopharmacy plays a central role in ensuring the quality, safety and regulatory compliance of radiopharmaceuticals used for diagnostic and therapeutic purposes. Given the complexity and multidisciplinary nature of the radiopharmaceutical circuit, professional practice evaluation represents a key tool for continuous quality improvement. This study aimed to evaluate professional practices in hospital radiopharmacy using a structured process-based clinical audit and to identify priority areas for quality improvement. METHODS: A prospective professional practice evaluation was conducted in the radiopharmacy unit of a university hospital nuclear medicine department. Eleven audit grids comprising 156 criteria were developed based on national regulations, international guidelines and good radiopharmacy practice standards. The evaluation covered all major stages of the radiopharmaceutical circuit including reception and storage, preparation, quality control, dispensing, cleaning and disinfection and radioactive waste management. Data were collected through direct observation and document review and analysed descriptively. Identified non-conformities were prioritised and addressed through a quality improvement action plan structured according to the Plan-Do-Check-Act (PDCA) cycle. RESULTS: Overall compliance with professional practice standards was 87% across evaluated processes. High compliance was observed for workflow organisation, radiopharmaceutical preparation and quality control activities and radiation protection measures. However, recurrent non-conformities were identified, mainly related to hand hygiene practices, traceability of prepared radiopharmaceuticals, radiological controls at reception, equipment stabilisation procedures and radioactive waste management. Based on these findings, a structured and prioritised action plan was developed, including short-, medium- and long-term corrective measures. CONCLUSIONS: Professional practice evaluation using a process-based clinical audit is an effective approach for identifying strengths and areas for improvement in hospital radiopharmacy. Implementation of a structured PDCA-based action plan supports continuous quality improvement, enhances patient and staff safety and promotes compliance with professional and regulatory standards. This methodology may be transferable to other radiopharmacy settings.