Q: What are reasonable time frames to establish for activating excursion action plans for humidity, temperature, and pressure differentials?

A: Choosing the time frames to activate excursion action plans requires a judgement call. Often, your certifier can provide helpful information in terms of best practices examples that they see across the various organizations they work with. Your certifier may also have suggestions for small improvements or adjustments that you can make in your facility that will deliver significant benefits.

USP does not establish a time limit beyond which excursions must be reported. Many facilities rely on the 1 hour mark, as an excursion that lasts less than 1 hour is likely to have minimal impact. Of course, if the excursion is egregious, that is a different story. However, once the excursion exceeds 1 hour, adjustments will be required. All excursions should be reported to the appropriate committees in your organization, such as the infection control committee or the quality committee, for example. It is important to document and report every excursion; this information should not remain only within the pharmacy. In addition, check with your state board as they may have specific reporting requirements for excursions.

Q: Can multiple people be assigned to the designated person role?

A: Currently, USP <800> is the only official chapter that lists a designated person role, in which it specifies a single person. However, in the proposed revisions for USP <795> and USP <797>, this role is listed as the designated person(s). I would recommend against splitting the role up into specific areas, such as a cleaning designated person or a policy designated person, as this role needs to serve in a more global capacity. Nonetheless, there are allowances in the proposed revisions wherein the designated person could designate someone else to oversee certain activities. Ultimately, the designated person should serve as the team quarterback with a full understanding of the game plan, and the ability to delegate tasks as necessary.

Q: How often should standard operating procedures be reviewed?

A: The proposed revision for USP <797> sets 1 year as the expected time line for reviewing your standard operating procedures (SOPs). While every single policy in the pharmacy may not need an annual revision, it is important to prioritize reviewing the SOPs that cover areas experiencing significant change or new regulations, as well as the sterile compounding SOPs in accordance with this time line.

At a minimum, the designated person should review compounding SOPs annually. In addition, I recommend enlisting students and new practitioners in the review process for a fresh set of eyes. While they will not serve as the final decision maker for updates, students and new practitioners can help review and highlight any areas that need to be addressed, such as areas where standard practice, forms, and the SOPs do not match.

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, is director of accreditation and medication safety for Cardinal Health and is a member of the USP Compounding Expert Committee. She is the author of The Chapter <800> Answer Book and many resources for pharmacy. Her comments herein are her own and not official information from USP.