Sterile Compounding – Consistent Interpretation

by Expert Advice

Sterile Compounding – Consistent Interpretation

by Expert Advice

by Expert Advice

Sterile compounding is the focus again in the August and September Perspectives articles entitled “Consistent Interpretation.” Accordingly, it covers sterile compounding scoring interpretations.

Sterile Compounding Scoring

In brief, the August article provided scoring advice. It covers failing to certify the primary engineering control every six months. This includes the hood or Biological Safety Cabinet. They also discuss outcomes if the surveyors should fail to certify the hoods and, the organization is performing non-sterile to sterile compounding also known as “high risk” compounding. In this case, they state that surveyors should call SIG for advice.

Our interpretation of this is that it could lead to SIG advising the surveyors of an immediate threat situation or other route to PDA. Also, the article states that if the scheduled certification fails and the organization does not complete remediation, this too will be scored. We would add that the remediation must be timely and thorough.

They also point out that the sterile compounding program should report to the hospitals QAPI program. Here is our specific advice. Any failures in:

  • PEC or SEC testing
  • Viable surface or air sampling
  • Finger tip or media fill testing for existing employees

Should all be reported to the P&T committee and to the infection control committee. This will ensure the issue reaches the QAPI pipeline.

In addition, the August update also suggests how to take advantage of the full expiration dating permitted by USP 797. Place the primary engineering control (PEC) inside of an ISO 7 environment. If it is not, it limits you to 12 hour dating for low and medium risk sterile compounds.

Patton Healthcare Consulting provides Joint Commission Compliance Assistance. In addition, we offer a full range of pre-survey and post survey services to healthcare organizations. Contact us to learn more.


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