In an on-demand session available during the ASHP Midyear Clinical Meeting and Exhibition titled Sterile Compounding: Benchmarking and Improving Your Practice,” Patricia C. Kienle, MPA, RPh, BCSCP, FASHP, director, accreditation and medication safety, Cardinal Health, described the current and proposed USP guidelines related to building and maintaining sterile environments to ensure patient and healthcare provider safety.

In the presentation, Dr. Kienle explained the key differences between the 2008 version of USP <797> and the proposed 2019 revision, identifying the top noncompliant elements of sterile compounding practice. She summarized sterile compounding practice-compliant methods for personnel training and detailed the methods used to comply with environmental monitoring of sterile compounding facilities. In addition, she addressed work practices, beyond-use date standards, handling hazardous drugs, documentation, and monitoring requirements to ensure safe, sterile compounding environments.

Revisions to USP <795> and USP <797>, related to nonsterile and sterile compounding, respectively, Dr. Kienle explained, were expected in December 2019, but those chapters were appealed due to issues surrounding beyond-use-date (BUD) requirements, and that process is still ongoing with USP.

“We will see a revised chapter at some point, and when it is first published by USP, there will be at least a 6-month time to come in compliance,” she said. In the meantime, she added, “The facility design and a lot of other pieces that are in there can certainly be incorporated now and are clearly best practices.”

USP <800>, which pertains hazardous drugs, became official on December 1, 2019, said Dr. Kienle, “but it is in a kind of limbo” because it will not be “compendially” enforceable until USP <795> and <797> are official. Similarly, USP <825>, a new chapter governing radiopharmaceutical and nuclear medicine, became official on December 1, 2020, but is not yet enforceable because it is also mentioned in USP <797> and <795>, she added.

On the disinfecting front, she stressed the need for cleaning with a properly-diluted (if necessary) detergent, adding that ready-to-use solutions are preferred, and recommended that disinfectants contain 70% isopropyl alcohol. Dr. Kienle noted that the proposed 2019 revisions include cleaning frequencies, specifying that surfaces of sinks must be cleaned and disinfected at least daily, and a sporicidal agent must be applied at least monthly.

Properly following cleaning-product use instructions is also key, Dr. Kienle said. “Are people leaving [cleaning solutions] on for the appropriate dwell time?,” she asked. “If you are not, the effectiveness of those solutions is questionable at best. The manufacturers’ information says how long that surface needs to stay wet, and you need to comply with that as well.”

Commenting on environmental monitoring, Dr. Kienle delineated daily requirements, including pressure and temperature, noting that the proposed <797> revision also includes humidity monitoring. “Make sure that you are getting geared up for that,” she stressed. Electronic air sampling, she said, must be done every 6 months. She added that although the current testing requirement for surface sampling is “periodic,” she anticipates that this mandate frequency will change to monthly.

Focusing on personnel, Dr. Kienle cited the requirement for suitable initial and requalification training, as well as remedial training, plus ongoing monitoring of staff. “Not everybody is geared for this precision that we need for IV techs and pharmacists who work in the IV areas. Sometimes, some remedial actions are necessary because things go wrong and need to be corrected,” she said. “Could you justify if something went wrong in your organization? Have you done everything you can to be able to make sure that people in there are compliant and know what they are doing?”

In addition to the currently required annual gloved fingertip/thumb and media fill tests, Dr. Kienle noted, the proposed 2019 revision requires observing hand and garb hygiene every 6 months.

In summation, Dr. Kienle stressed that patients expect compliant practices, calling on attendees to strive for full sterile compounding compliance to required standards, including training and monitoring personnel, at their institutions. In addition, she recommended researching available IV workflow software to explore how it can best be incorporated into practice.