Mabru Éloïse, Fafi Faiza, Merité Nicolas, Moubarik Chahrazad, Lao Solange
Radiopharmacie, centre hospitalier intercommunal Toulon-La-Seyne, hôpital Sainte-Musse, Toulon, France.
Radiopharmacie, centre hospitalier intercommunal Toulon-La-Seyne, hôpital Sainte-Musse, Toulon, France.
Ann Pharm Fr. 2024 Jan;82(1):146-162. doi: 10.1016/j.pharma.2023.08.004. Epub 2023 Aug 18.
Radiopharmacy is a high-risk hospital pharmacy carried out in a complex regulatory environment. Adopting an audit culture is a priority issue to secure the radiopharmaceutical drug circuit. The objective of the study is to demonstrate the value of cross auditing, a hybrid between internal and third party auditing.
A 125-item evaluation tool applying to the entire radiopharmacy activity was designed. Two radiopharmacies were audited internally and then a cross-audit was organized between the two units.
For one of the units, 12 items were rated differently during the two audits. Four of the ten non-conformities that were not observed during the internal audit were rated as critical by the radiopharmacist auditor. For the second radiopharmacy, 15 items were rated differently, two of which were rated as critical.
Personal opinion may unintentionally influence a reasoning, but the independence of the auditor during cross auditing is a guarantee of objectivity. It is an alternative to internal audits which have become routine and less efficient and unlike third party audits, the auditor is familiar with the constraints and concerns of the field. The interest of this approach goes beyond the simple evaluation of non-conformities. Cross auditing encourages the sharing of experience and know-how between professionals in the same field. It creates a dynamic collaboration between establishments and contributes to the individual and collective improvement of the safety of the radiopharmaceutical drug circuit.
放射药房是在复杂监管环境中开展的高风险医院药房。采用审核文化是确保放射性药物流通安全的首要问题。本研究的目的是证明交叉审核(一种内部审核与第三方审核相结合的方式)的价值。
设计了一个适用于整个放射药房活动的包含125个项目的评估工具。对两家放射药房进行内部审核,然后在两个单位之间组织交叉审核。
对于其中一个单位,在两次审核期间有12个项目的评级不同。内部审核未发现的十个不符合项中有四项被放射药剂师审核员评为关键项。对于第二家放射药房,有15个项目的评级不同,其中两项被评为关键项。
个人观点可能会无意中影响推理,但交叉审核期间审核员的独立性是客观性的保证。它是内部审核的一种替代方式,内部审核已变得常规且效率较低,与第三方审核不同的是,审核员熟悉该领域的限制和关注点。这种方法的意义不仅在于对不符合项的简单评估。交叉审核鼓励同一领域专业人员之间分享经验和知识。它在机构之间建立了动态协作,并有助于放射性药物流通安全的个人和集体改进。