Increased Scrutiny of Sterile Compounding

by Expert Advice

Increased Scrutiny of Sterile Compounding

by Expert Advice

by Expert Advice

Reducing the risk associated with sterile compounding. Indeed the most concerning and important article in Perspectives.

In fact, we warned about enhanced scrutiny on sterile compounding in our July Newsletter. This perception has certainly become a reality. And, it will catch many hospitals by surprise if not properly prepared.

Expanded Dialog On Sterile Compounding

The October Perspectives mentions how multiple sessions in the survey process will now include expanded dialogue about sterile compounding. This includes:

  • Tracers conducted by the life safety code specialist
  • Document review
  • Discussion during the MM and IC system tracers and the competency assessment tracer

Joint Commission published three tables along with the article. One on the physical environment for compounding. A second on issues the surveyors may observe during survey. And a third on competency expectations that pharmacy the staff preparing sterile products must document. These competency expectations come directly out of USP Chapter 797. Based on our consulting work, we believe that many hospitals considered these competencies to be optional. But that belief is clearly a mistake. The staff that prepare sterile products must document competencies including:

  • Written didactic testing
  • Media fill testing
  • Gloved fingertip sampling

Learn The Processes

If you are not familiar with these terms and techniques you will want to rapidly become expert in these processes. Also, you must know if your hospital only performs low risk and medium risk category compounding. And in addition, if it performs any high-risk compounding. If you perform high risk compounding, you must conduct the previously mentioned competency assessment techniques every 6 months. Plus, you must be what is called end product testing.

To us, the sterile product preparation sounds like another problematic area. It’s a sector where the expertise of those surveying the hospital has the potential to exceed the content knowledge of those performing the job. We have seen the in recent years the enhanced expertise of the life safety code surveyors and the expertise of those evaluating high level disinfection and sterilization to the point that these are the most frequently scored issues on everyone’s hospital survey. Sterile product preparation may be the next huge survey issue facing hospitals. There are many learning opportunities from USP, American Society of Health-System Pharmacists (ASHP) and even commercial software tools to help you prepare.

In conclusion, our advice is don’t wait!


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