Sterile Compounding Standards

Do you need clarity for sterile compounding standards? The column entitled Consistent Interpretation provides valuable guidance from TJC.

Sterile Compounding Standards – Consistent Interpretations

Hospitals are at a disadvantage because TJC started a rigorous evaluation of sterile compounding. But, unlike their home care program, TJC has not embedded the sterile compounding standards in the hospital manual. However, they are evaluating them in stealth mode. These requirements all come from USP Chapter 797. Evaluations for the past decade have been only superficial. Today’s review provides far more exacting compliance details.

The column identifies a potpourri of issues that can be scored in the infection control chapter. These include:

1. Failure to wear proper PPE when performing sterile compounding. For example, a hair cover.
2. Failure to document the hood and clean room cleaning as required.
3. Identification of rust on the IV hood that you are unable to clean properly.
4. Staff wearing makeup while performing sterile compounding.
5. Not dedicating mops to clean the buffer and anterooms.
6. Fabric backed chairs that cannot be adequately cleaned in the compounding room .
7. Using an alcohol swab to clean more than one critical site (port or vial top)
8. Donning shoe covers as the last step in the garbing process instead of the first.
9. Compounding staff having an exposed neck rather than a snug sterile gown around the neck.

Here’s our suggestion. Get a copy of the following Joint Commission documents:

• Home care medication compounding standards
• Medication certification standards

In fact, both do a nice job of breaking out discreet concepts in elements of performance. And they are easier to understand vs. reading the lengthy narrative USP 797 document!

Patton Healthcare Consulting

Patton Healthcare Consulting advises organizations on Sterile Compounding Standards and other ongoing compliance challenges.