Pharmacy leaders have taken many steps over the past decade to bolster both infection control and the safe handling of hazardous drugs. Key to achieving these safety goals is the creation of rigorous, regulatory-compliant protocols to ensure the safety of staff as well as patients. These measures should begin far before the time when items are being prepared for use in the cleanroom—rather, safe handling should be a priority as soon as supplies are delivered to the facility and then throughout at all stages of drug handling. At Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, infection control and hazardous drug residue protocols have been examined to microscopic levels and implemented from the moment drugs arrive at the hospital.
Our Lady of the Lake, licensed for just over 1000 beds, is not unlike most health systems in that medications often arrived in less-than-ideal condition. Historically, there were drug totes that were coated with dirt and grime and cardboard boxes often harbored bacteria. To address these issues, we worked with our vendors to troubleshoot opportunities for reducing the incidence of dirty totes and mishandled shipments that contained broken products. We also mandated that the distribution center where the totes originated include hazardous drug warnings on the exterior of the tote itself. Despite these efforts, we still occasionally received totes that did not meet our safety expectations.
In response, we decided to increase precautionary measures for all shipments to better limit our facility’s and team members’ exposure to contaminants and hazardous drug residue. These precautionary measures for all shipments have become the standard wipe protocol currently in place at Our Lady of the Lake (see the TABLE).
While our standard wipe protocol addressed the challenge of contaminated totes, there were additional issues that needed to be addressed. To do so, our Quality and Patient Safety Committee, with the help of our Infection Control team, implemented a plan to ensure problems are identified and best practices are applied throughout the organization. Environment of Care (EOC) audits are conducted on a routine basis for both our acute and non-acute hospital departments, and action plans are subsequently constructed when opportunities for improvement are noted. Following one such audit, our Infection Control team put in place the practice of leaving all corrugated cardboard in the receiving areas of the hospital to prevent containers from bringing contaminants such as dust, debris, and other microorganisms into a clean space or department. The pharmacy department adopted this policy and no longer allows any corrugated cardboard into the pharmacy space. Instead, the policy is to break down boxes in a designated area and to wipe all products prior to entry. We incorporated this process into our previously implemented wipe protocol (see the FIGURE).
The standard wipe protocol follows the processes delineated within USP Chapters <797> and <800>, along with the recommendations from our Infection Control team and EOC audit recommendations. The goal of this protocol is to eliminate contaminants and decrease hazardous drug residue amounts in our pharmacy department and cleanroom. By taking the protocol a step further with input from the Infection Control team, we were able to improve the overall process and further reduce the bioburden to our pharmacy departments as a whole. This dynamic approach both reduces contaminants and prioritizes safe handling of hazardous drugs before they enter our facility to support our priorities of ensuring sterility and safety for our patients and staff.FIGURE
High-level Summary of Wipe Protocol
Products arrive in a variety of forms, including plastic totes, refrigerated totes, and cardboard boxes. The team member dons ASTM D-6978 chemo rated gloves before opening any tote or box. Items are checked in using a cart covered with a chemo pad in a neutral pressure room. Cardboard boxes are broken down away from any work areas that are near cleanrooms or passthroughs. Loose items in totes or cardboard boxes are wiped down with disinfectant and placed into clear zipper seal storage bags.
Bags containing nonhazardous items are subsequently wiped down with disinfectant (with the appropriate dwell time) followed by a non-sterile IPA before being placed in a passthrough into a cleanroom. Once the bags of products are in the nonhazardous cleanrooms, items are removed from the bags and placed in storage. Upon retrieval, the product is removed from the box and the vials are wiped down with a sterile IPA prior to being placed in the ISO 5 environment.
Hazardous drugs are shipped in clearly marked totes with the product received in chemo labeled bags. All bags containing hazardous items (bag is not opened in neutral pressure area) are wiped down with disinfectant (with the appropriate dwell time) followed with a non-sterile IPA before being placed in a passthrough into a cleanroom. Hazardous drugs introduced into a cleanroom are left in their bags and placed in storage to reduce hazardous contamination in the storage unit. Bagged product is removed as needed, the bag is opened, and the vials are subsequently removed from their boxes. The vials are then wiped down with disinfectant (with the appropriate dwell time) followed by a sterile IPA prior to being placed in an ISO 5 hood.
Wendy Gaudet, PharmD, DPLA, is vice president of operations at Our Lady of the Lake in Baton Rouge, Louisiana. She earned her bachelor of science at the University of Arkansas at Monticello and her doctorate of pharmacy degree from University of Louisiana at Monroe, College of Pharmacy.
Tommy Greene, RPh, is the pharmacy director of integrated operations at Our Lady of the Lake Regional Medical Center. He earned his bachelor of science degree from Louisiana State University and bachelor of pharmacy degree from Northeast Louisiana University.