Pharmacy Purchasing & Products recently held a webinar entitled:
Evolving Accreditation Inspections of the Cleanroom
Presented by Patricia C. Kienle, RPh, MPA, BCSCP, FASHP

The following questions were submitted by attendees.
The webinar slides and full presentation can be downloaded at pppmag.com/webinars.

Q: What are the key components to establish immediate use competencies for those outside of pharmacy?

A: While it may be feasible for smaller hospitals to integrate immediate-use competencies into an annual safety program, this approach will likely be difficult for larger facilities. Everyone who compounds or oversees compounding has to have the initial competency, but determining competency frequency after that is left to each facility.

It is not only nursing staff that need immediate use competency documented. Be sure to include anesthesia, imaging, perfusionist, and others who compound for immediate use in your initial and requalification competency and documentation.

When considering the components of a competency assessment, include a hands-on process alongside the more common didactic lesson, which is often a PowerPoint presentation of the definitions of immediate-use and the limitations present in the facility. Usually, the nursing education department will have effective models for hands-on teaching, which can serve as the basis for pharmacy to build competency.

Q: What training is required for the Designated Person role?

A: Currently, <797> does not provide a specific outline of the training requirements for the designated person. Instead, establishing the designated person training is left up to each health system. This approach is similar to the development of the infection control practitioner role 30 years ago: when this role was first created, its definition and training were not prescriptive. However, over time, the training for this role evolved into highly structured requirements. I think we are in an analogous situation, and the training for the designated person role will likely be refined over time.

Some organizations provide designated person training, or you can create an in-house training effort. Attending the ASHP training sessions will provide an excellent foundation for the designated person training. It is equally important to provide hands-on training specific to the USP requirements. Consider the designated person’s role as a lifelong learning situation. As the hospital pharmacy landscape is constantly evolving, the designated person’s skill set must evolve alongside it.

Q: Is it necessary to conduct media-fills and gloved-fingertip sampling with post-media-fill surface sampling in a BSC if this is already done for nonhazardous compounding and parenteral nutrition?

A: USP <797> does not offer a clear answer to this scenario. Refer to your state policies, as some states delineate a more stringent approach for this practice. If your state does not currently address this, you might consider conducting this testing in both hoods initially, and then every 6 months for Category 1 and 2 compounding alternating between the laminar air flow hood and the BSC. Consider what makes the most sense with your practice, what works in your organization, and what is required by your state board of pharmacy.

Q: What is the best way to explain to nursing staff that the BUD does not affect infusion time or the need to remake an IV?

A: I would refer you to the article that Kevin Hansen and I wrote in Pharmacy Purchasing & Products’ 2024 March supplement issue, Defining Storage and Administration Terms for CSPs (accessible at pppmag.com/article/3234). The article addresses this issue in some detail in addition to providing clear direction on establishing BUDs.

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, is the director of accreditation and medication safety for Cardinal Health. Her comments herein are her own and not official information from USP.