The FDA recently published a draft document. It’s entitled “Insanitary Conditions at Compounding Facilities: Guidance for the Industry.” You may obtain a PDF copy of this guidance document here. This post details steps you should take to ensure an effective sterile compounding evaluation.
Sterile Compounding Evaluation
The document provides an extensive list of what the FDA calls “insanitary conditions.” It incorporates issues found during surveys at organizations that perform sterile compounding. As you read through the examples, they may seem like conditions you have encountered at some point in your hospital setting. The highlights include:
- Preparing drugs during construction in an adjacent area without adequate controls to prevent contamination
- Standing water or evidence of water leakage in the production area or adjacent area
- Engaging in sterile compounding wearing non-sterile gowns or gloves
- Putting on garb in a way that contaminates the gown or apparel
- Failing to disinfect gloves frequently during sterile compounding
- Leaving and re-entering the classified space to perform sterile compounding without first replacing attire
- Conducting sterile compounding while blocking “first air” in the hood
- Lack of adequate environmental monitoring
- Lack of adequate personnel sampling
- Inadequate pressure differentials in classified spaces
- Air returns next to the HEPA filter rather than near the floor
- Open doors into classified spaces
- Loose ceiling tiles in classified spaces
- Overhangs and ledges in classified spaces that collect dust
- Sinks, drains or water sources in the buffer area / ISO 5 area
- The presence of particle generating equipment unnecessary for aseptic operations in the ISO 5 buffer zone
- Not using or the improper or infrequent use of a sporicidal agent in the classified spaces
- Failure to disinfect equipment or supplies moving from lesser quality air to higher quality spaces
This is only a sample of the conditions they have seen during a sterile compounding evaluation. But, the sample is a concern because it has too many similarities to hospital conditions we see or the TJC sees on survey.
What To Do About It? Remediation
If you identify air or surface microbial contamination above an actionable threshold, there are at least five immediate actions necessary:
- Notify QAPI and or infection prevention of the finding for technical assistance and analysis of the pathogenicity of the growth.
- Analyze potential root causes and sources for this growth and trend analysis if it is a repeat finding.
- Promptly undertake remedial actions. This includes retraining, re-cleaning, retesting as well as corrective action on any other root causes identified in your analysis.
- Document your swift and thorough actions taken in writing.
- If found during a PEC or SEC certification, annotate the report you provide to the surveyors to identify corrective actions.
Common Failure Points
Two common sterile compounding evaluation failure points are noted on both consults and TJC surveys. The first and most common failure point is forgetting to document your corrective actions. You should have a written remediation plan, so you know where to start on corrective action.
The second most common failure point is starting corrective action too slowly. Don’t wait for the hospital content expert(s) to return to work to lead the implementation of corrective action. If you have a written remediation plan you will know where and how to start before your content experts return from vacation.
The Massachusetts State Board of Pharmacy developed remediation advice for handling above-action-level environmental monitoring results. Massachusetts, you might remember, is home to the New England Compounding Center. They appear to be ahead of most states with improving practices. Their guidance document provides excellent advice. It includes the detective work necessary to help determine why you may have seen this growth. They suggest a re-evaluation of personnel work practices. This includes cleaning procedures, operational procedures and air filtration efficiency as part of the RCA. You may download a copy of their advisory document here.
An Important Final Step
A key last step in the remediation is always a retest for microbial growth. In fact, you anticipate a clear retest but, it doesn’t always work that way. So, you may need to reanalyze all potential causes and improve your remediation strategy. In addition, as an organization, you should discuss and decide upon potential actions. This includes not using USP 797 extended duration expiration dating. But instead, reverting back to 12 hour dating as used in a segregated compounding area, without sophisticated air handling and design features.
Here is the key point. Do this as a team within the organization and involve leadership. Use a formal hospital wide committee such as infection prevention, not in isolation. The repercussions of an inadequate remediation effort can affect patient care. Furthermore, it may impact your accreditation survey outcome leading to an adverse decision.
Patton Healthcare Consulting
Whether it’s a sterile compounding evaluation or implementing other Joint Commission standards, we can help. Patton Healthcare Consulting provides Joint Commission Compliance Assistance and a full range of pre-survey and post survey services including support developing healthcare’s reporting culture.