Development of an inter-radiopharmacy cross-audit tool: evaluation on two hospital sites
Description
Radiopharmacy is a hospital pharmacy activity subject to complex regulations. Ensuring the safety of the radiopharmaceutical drug circuit is a priority. A quality approach is essential. With this in mind, the radiopharmacy at Sainte Musse hospital in Toulon has set up inter-radiopharmacy audits. The principle is based on reciprocity: the auditor becomes the audited. In January 2020, 63 radiopharmacies were contacted for a positioning survey on cross-audits. Radiopharmacists expressed an average interest of 8.2/10. Following this survey, a tool was developed to assess radiopharmacy practice in its entirety. It is based on the texts governing radiopharmacy. Checks are carried out on the efficiency of the documentation system, personnel, the reliability and performance of premises and equipment, the radiopharmaceuticals circuit and aspects relating to hygiene and radiation protection. The tool was tested in 2 hospital radiopharmacies in the PACA region. Initially, each unit was assessed by the site radiopharmacist. Subsequently, a cross-audit was organized between the 2 radiopharmacies. The results showed that in cross-auditing, the auditor's neutrality guarantees a more objective analysis of non-conformities. Peer-to-peer auditing encourages the sharing of experience and helps to find collective solutions to common problems. Last but not least, it enables disparities between practice and regulatory requirements to be highlighted
Abstract (French)
La radiopharmacie est une activite de pharmacie hospitaliere soumise a une reglementation complexe. La securisation du circuit des medicaments radiopharmaceutiques (MRP) est un enjeu prioritaire. L'inscription dans une demarche qualite est indispensable. C'est dans cet objectif que la radiopharmacie de l'hopital Sainte Musse a Toulon a mis en place des audits inter-radiopharmacies. Le principe est base sur la reciprocite: l'auditeur devient l'audite. En janvier 2020, 63 radiopharmacies ont ete contactees pour une enquete de positionnement sur les audits croises. Les radiopharmaciens ont exprime un interet moyen de 8.2/10. a la suite de cette enquete, un outil est elabore pour evaluer la pratique de la radiopharmacie dans sa globalite. Il est concu a partir des textes qui regissent l'activite de radiopharmacie. Les elements de controle portent sur l'efficience du systeme documentaire, le personnel, la fiabilite et la performance des locaux et des equipements, le circuit du MRP et les aspects lies a l'hygiene et a la radioprotection. L'outil a ete teste au sein de 2 radiopharmacies de centres hospitaliers de la region PACA. Dans un premier temps, chaque unite a ete evaluee par le radiopharmacien du site. Par la suite, un audit croise a ete organise entre les 2 radiopharmacies. Les resultats ont permis de constater que lors des audits croises, la neutralite de l'auditeur garantit une analyse plus objective des non-conformites. L'audit entre pairs favorise le partage d'experience et permet de trouver des solutions collegiales aux problematiques communes. Enfin, il permet de soulever les disparites entre la pratique et les exigences imposees par la reglementation. (auteur)
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Additional details
Additional titles
- Original title (French)
- Elaboration d'un outil d'audit croise inter-radiopharmacies: evaluation sur deux sites hospitaliers
Publishing Information
- Imprint Pagination
- 139 p.
- Report number
- FRNC-TH--16165
INIS
- Country of Publication
- France
- Country of Input or Organization
- France
- INIS RN
- 56003145
- Subject category
- S07: ISOTOPES AND RADIATION SOURCES; S62: RADIOLOGY AND NUCLEAR MEDICINE;
- Resource subtype / Literary indicator
- Thesis
- Descriptors DEI
- AUDITS; COMPLIANCE AUDITS; DOCUMENTATION; EFFICIENCY; EVALUATION; HOSPITALS; MEDICAL PERSONNEL; NUCLEAR MEDICINE; POSITIONING; QUALITY ASSURANCE; RADIATION PROTECTION; RADIOPHARMACEUTICALS; REGULATIONS; RELIABILITY; SAFETY; UNSEALED SOURCES
- Descriptors DEC
- AUDITS; BUILDINGS; DRUGS; LABELLED COMPOUNDS; LAWS; MANAGEMENT; MATERIALS; MEDICAL ESTABLISHMENTS; MEDICINE; PERSONNEL; QUALITY MANAGEMENT; RADIATION SOURCES; RADIOACTIVE MATERIALS
Optional Information
- Notes
- 83 refs.; Available from the INIS Liaison Officer for France, see the INIS website for current contact and E-mail addresses