Contrary to popular belief – and practice – sterile compounding compliance standards extend far beyond the hood, or cleanroom. All too often, health systems overlook standards in other areas where sterile compounding may occur – like the ICU, oncology clinic, emergency department, and other ambulatory care and procedural areas. Many health systems mistakenly assume they’re in compliance, even though they’re overlooking important areas of USP<797>/<800>.
Are you avoiding common compliance pitfalls?
Cardinal Health conducts dozens of sterile compounding compliance assessments every year. We find that health systems typically commit these common errors:
- Failure to read, or to correctly interpret, certification reports on the hood’s performance
- Focusing only on compliance within the pharmacy, and not in other areas where sterile compounding occurs
- Failure to realize that a negative pressure room will be required for handling hazardous drugs
- Overlooking microbial monitoring, or failure to appropriately interpret and monitor results, and failure to take effective corrective actions
- Failure to complete environmental sampling of both surfaces and air
Expertise to give you peace of mind
Our proven Sterile Compounding Assessment focuses on three major areas to identify gaps and prioritize the areas that are most likely to most significantly impact compliance:
We assess your clean room and all other locations where non-hazardous and hazardous sterile compounds are prepared
We guide your facility in the development of policies for education, training, garbing, and documented competence; based on USP <797>/<800> requirements and our observation of your operations
We support the ongoing monitoring of your processes, personnel and facilities to improve compliance
Be confident in your compliance
Don’t take risks when it comes to sterile compounding compliance. Let our experts help you avoid the common pitfalls. Contact us today.