Category: Professional Posters
Purpose: An ongoing pattern of environmental monitoring excursions related to organism growth from surface and air sampling in a sterile compounding suite was identified in a mid-size community hospital over a multi-year period. This case presents the methodology utilized to trend culture results, investigate potential sources of contamination, create remediation action plans, and provide follow up on the identified issues and culture results.
Methods: A spreadsheet was used to track growth on environmental culture plates over time, by location, within the sterile compounding suite. A pattern of growth appeared to be present related to the time of year for sampling, and proximity to entrance points. An investigation into potential contamination sources was conducted by a multidisciplinary team for each excursion. The depth of the investigations escalated after each sampling failure. Investigations sequentially included; evaluating environmental conditions, staff observations, evaluating cleaning processes, verification of airflow and pressure isolation, inspection of air filtration equipment, wall and floor inspections, evaluation of areas adjacent to the compounding suite, assessment of equipment placement, and evaluation of air handlers. Sequential action plans included; terminal cleaning and resampling, staff education, establishing twelve hour beyond use dating, shifting compounding to a satellite pharmacy, reapplication of epoxy paint on clean room walls, removal of carpet in the pharmacy, relocation of air returns outside the clean room, removing refrigerators from the area adjacent to the anteroom, removal of equipment from the anteroom, changes to the cleaning procedure, treatment with aerosolized hydrogen peroxide, and implementation of UV-C disinfection outside of the clean room. Growth continued to be identified which led to the engagement of consultants to identify facility design and process issues, as well as to suggest steps to remedy the ongoing situation.
Results: Contracted subject matter experts identified process issues that led to policy revisions and the development of a re-training program for staff on the new processes. They also determined that the facility design did not maintain a sterile environment. Observations included wooden doors that opened inward, the ante-room opened directly to a receiving area, air exchanges per hour and pressure isolation were at the low end of the acceptable ranges, the epoxy paint on the walls did not meet standards, light covers made cleaning difficult, and air return grates were on the ceiling next to the incoming filtered air.
Construction began to address all identified issues. Automatic sliding glass doors were installed. A controlled, not ISO-classified room was added to separate the ante-room from the receiving area. Fan-assisted HEPA filters were installed to increase the pressure differentials and air exchanges. The walls were covered with a seamless, smooth, non-porous, solid-surface system. Light covers were reversed for more effective cleaning. Air return vents were relocated low on the walls to ensure proper airflow. After a terminal cleaning, air and surface cultures showed no growth on all but one plate, which displayed only alert levels.
Conclusion: A systematic approach to investigating sterile compounding suite environmental excursions can help to identify sources of contamination and factors negatively impacting the sterile environment. External consultants may be useful in developing additional action plans and securing required resources when common strategies fail to rectify recurrent environmental excursions, creating the need to take a “mulligan” and reconstruct the suite. Continuous training of staff, including education on the rationale for why things must be done a specific way, along with staff observations are imperative to ensure continuing compliance.