医院PIVAS洁净区环境监测标准探讨

Discussion on Clean Area Environmental Monitoring Standards of PIVAS in Hospital

目的:完善医院静脉药物集中调配中心(PIVAS)洁净区环境监测标准。方法:参考相关国家标准及规范,结合工作实践,探讨《静脉用药集中调配质量管理规范》对已投入使用的PIVAS洁净区环境监控要求存在的问题。结果:《静脉用药集中调配质量管理规范》未对洁净区的检测方法标准作出明确规定;对压差、照度、风速无具体数值规定;未对悬浮粒子的监测进行规定,对沉降菌和浮游菌的规定不明确;缺少对风速、悬浮粒子监测频次的规定。结论:建议《静脉用药集中调配质量管理规范》对洁净区的环境监测标准应单独列出,并对检测方法、监测项目、判定标准及监测频次予以明确规定,使医院药学人员更易操作和执行。

OBJECTIVE:To improve clean area environmental monitoring standards of Pharmacy intravenous admixture service(PIVAS)in hospital. METHODS:Referring to related national standards and specifications,combined with the work practice,the existing problems of environmental monitoring requirements in Quality Management Standard for Pharmacy Intravenous Admixture to clean area in PIVAS were explored. RESULTS:There was no provision on clean area environmental monitoring standards in Quality Management Standard for Pharmacy Intravenous Admixture;there was no specific numerical value of pressure difference,illumination and wind speed;there was no rule on airborne particles;there was no clear provision on settling microbe and airborne microbe;there was also no rules on the frequence of wind speed and airborne particles monitoring. CONCLUSIONS:Clean area environmental monitoring standards should be separately listed in Quality Management Standard for Pharmacy Intravenous Admixture,and clear provisions are given on detection method,monitoring project,judging standard and monitoring frequency,so that pharmacists are easy to operate and carry out.