Don’t Be Afraid Of Contamination Testing B
ridget Gegorski, PharmD, was convinced her hospital system had done an outstanding job preparing for the implementation of USP General Chapter <800>. “Particularly for [NIOSH] Table 1 drugs and chemotherapy, we had implemented a number of processes that significantly cut down on hazardous drug contamination,” Dr. Gegorski, the medication safety officer at University Hospitals Health System, in Cleveland, told Pharmacy Practice News. These steps included both administrative controls, such as staff training, limiting access to areas containing hazardous drugs (HDs) and good housekeeping practices, as well as engineering controls such as biological safety cabinets, proper ventilation and negative pressure rooms. But surface contamination testing told her those steps had not been sufficient. “When we conducted surface contamination testing, we were still getting at least low positives in the environment, in places where we wouldn’t expect it—areas where we know the operators are doing things correctly and probably are even more cautious than I am about processes, so we didn’t expect to find contamination there,” said Dr. Gegorski, who spoke with Pharmacy Practice News in advance of a presentation on challenges in surface contamination testing at the 2021 virtual annual meeting of the National Home Infusion Association (NHIA). Studies have documented the importance of wipe sampling programs for identifying the sources of surface contamination in facilities that manage HDs. In 2019, researchers from the University of North Carolina retrospectively analyzed 5,842 individual surface wipe samples from 338 pharmacies over six years. Depending on the location and surface tested, 3.94% to 25.96% of samples had high levels of HD contamination, and the researchers concluded the highest levels of contamination were in preparation areas. Repeated wipe sampling lowered overall HD contamination: 45.24% of samples detected HDs with the first wipe compared with 31.64% for subsequent wipes (Am J Health Syst Pharm 2019;76[9]:591-598). After the first round of surface wipe sampling in December 2018 detected contamination in several areas, University Hospitals engaged in all the recommended steps that should follow a finding of HD contamination, including: • cleaning the location with a deactivation/decontamination agent; • evaluating proper use of closed system drug-transfer devices; • observing work practice controls and the use of personal protective equipment (PPE); • revisiting PPE doffing procedures; • evaluating cleaning procedures and the cleaning and decontamination agents used; and
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The number of colony-forming units on this cleanroom sample exceeded the action level and mold was recovered. These results prompted an investigation into the source of the contamination and remediation efforts to prevent recurrence.
• assessing the appropriateness of cleaning frequency. “We did all that, and we were still finding positives, so we were trying to figure out where we were having particles escape,” Dr. Gegorski said. “Finally, we realized that HD particles found on the outside of vials from our wholesaler could be a significant source of contamination.” Several recent studies demonstrated that shipments of HDs can come into hospital pharmacies with existing surface contamination. For example, a 2020 literature review of 24 articles from 11 countries concluded that the majority of antineoplastic vials have surface contamination when they arrive (Eur J Hosp Pharm 2020;27[5]:313-314). So University Hospitals added a new step to its HD mitigation processes. “While USP <800> does not require this, our wholesaler has consented to labeling totes that contain HDs,” Dr. Gegorski said. “Those totes are immediately taken to a receiving area within the HD cleanroom where we store all oncology products. We don’t open the tote until we are in that area and then we wipe down all the container surfaces.” Pharmacy leadership may fear implementing a surface wipe contamination testing plan because they don’t want to find positives. “USP <800> says that you should do this testing, not that you must do it,” she noted. “But if you start testing and you find positives—and you’re almost certainly going to find positives—then ‘should’ becomes ‘must.’ You have to mitigate, document your action and then retest. People may not be too keen on that, but fortunately at our institution, our leaders supported our implementation of the process. Having leadership support is key.” Staff education is vital to a good sampling program, Dr. Gegorski said. “After our first round of sampling in December 2018, we realized that there was a lot of confusion and misinformation. We created education to explain the benefits of testing for HD contamination, the controls that are currently in place to prevent occupational exposure,
P H A R M AC Y P R AC T I C E N E WS CO M P O U N D I N G S P E C I A L E D I T I O N • 2 0 2 1
see CONTAMINATION TESTING, page 12
