Sterile Product Preparation

by Jen Cowel

Sterile Product Preparation

by Jen Cowel

by Jen Cowel

Perspectives recently published new medication compounding standards. Although it’s only a small article on page 2 in the publication, it’s worthy of greater exposure.

New Medication Compounding Standards

Approved for the home care program, the medication compounding standards are impacting surveys. In fact, this include both the new standards and the surveyor expertise. In a previous post, we detailed new medication compounding standards for the voluntary certification program. The new home care requirements appear identical, but with a different numbering scheme.
Medication compounding standards

Here’s the importance of the home care certification requirements. First, the Joint Commission detailed expectations for sterile product preparation. Second, they created a cadre of expert surveyors to conduct this analysis.

But, what happens if a survey expert is assigned to your survey team (a “compounding specialist”)? No doubt, they can identify potential flaws in your sterile product preparation. They have detailed knowledge about USP 797 and other chapters from USP. In fact, the new standard MC.02.01.01, EP 2 references 16 different USP chapters. These chapters deal with sterile, non-sterile and hazardous drugs, including different settings and conditions. As a matter of fact, the information is complex. It’s like understanding all the AAMI requirements, or NFPA manuals and their requirements.

What If You Don’t Have Home Care?

You might think, I don’t have to worry, I don’t have home care. Yet, a pharmacist trained to conduct these surveys may be assigned for a different reason. This includes TJC awareness about:

  • Performing high risk compounding
  • Complaints
  • Sentinel events

Or, if you are a large teaching hospital.

In the meantime, if you have home care pharmacy services keep this in mind. A skilled surveyor assigned to review the program works as a team. For example, they may assist the hospital team, evaluating sterile product preparation organization wide. Recent examples showcase how thorough surveyors are in sterile compounding evaluation. It’s a more detailed process than the what we have seen before.

Home Care Standards Prepublication

In addition, the prepublication version of the home care standards is now available to download. You may access it here. Regardless of whether you have home care; we encourage you to download the standards and self-assess your own organization against these new standards. The Joint Commission is developing an expertise and rigor on sterile compounding. It is very different that we have seen before.


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