Maintaining Ideal Facilities for Sterile Compounding

Patricia Kienle, BSPHARM, MPA, FASHP, talks about on the appropriate facilities in which to perform sterile compounding in this video, filmed during the 2019 American Society of Health-System Pharmacists (ASHP) Summer Meetings & Exhibition in Boston.

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Patricia Kienle, BSPHARM, MPA, FASHP: Pharmacy certainly needs the right facilities in which to mix these, and for the large part people have adequate facilities. They may not have ideal facilities. I would encourage people to take a look at revised 797 because there's a lot more detail in there about what needs to be done and how it needs to be monitored. And I think the monitoring piece, both from a personnel monitoring—so, the media fill test, the glove fingertip test, the adequate way we garb and can demonstrate that every 6 months—is important to know. Also, the facility monitoring has been beefed up in 797.

The air handling is very similar to what people have seen before. The surface sampling, the frequency is defined now—it hadn't been before; it used to say 'periodic'. Now it needs to be done monthly. So I think the surface sampling can be indicative of the way that people can monitor throughout the organization as well. You need to make sure that places where sterile products are being mixed are adequately handled, and are clean and uncluttered and functionally separate. Those may be terms that you hear from a joint commission surveyor, but I think that really transcends what we need to do throughout the health system. It can't just be an area where somebody goes in and, you know, sweeps off an area next to a sink and makes an IV. There needs to be a deliberate area where these are being done, appropriately cleaned, and monitored.