In recognition of the health hazards posed by HD exposure, USP <800> outlines various safety strategies to ensure the well-being of all health care workers who come in contact with HDs, be they dockworkers, couriers, pharmacy staff, nursing staff, etc. Among the comprehensive strategies outlined in USP <800> is the recommendation to conduct wipe analysis testing at least every six months in order to identify those areas within the facility where HD residue may be accumulating. Given the fact that regulations typically become more stringent over time—not less—it is wise to adopt USP <800> in its entirety, standardizing both its requirements and recommendations into the facilities’ policies and procedures. The following tips can be customized and incorporated into a specific pharmacy practice for improved compliance:
Many pharmacies were first introduced to wipe analysis during CSTD adoption efforts. The resultant data from the wipe analysis kit serve as a powerful tool to demonstrate the need for increased HD containment efforts, including an investment in CSTDs for both drug preparation and drug administration. However, the utility of these kits does not end here. It is important to recognize the need for ongoing monitoring of HD residue throughout the facility and commit to developing a regular wipe analysis program.
Use true wipe sampling kits for an accurate measure of HD residue in your facility. Fortunately, there are a variety of vendors that offer testing kits (see FIGURE 1). These test kits generally take one of two different approaches: In the most commonly available approach, the vendor provides a comprehensive kit with instructions detailing the sample collection process; once sampling is complete, the kit is mailed to the vendor for processing, and a report is subsequently received detailing the HD types and levels identified in the sample area. The level of detail in the report and the number of HDs tested are vendor dependent. However, most vendors test for an array of different HDs. The second approach, which is newer to the market, has the benefit of providing near instant results with no need to send the sample out for testing. Delivering results in 10 minutes, this turn-around-time can allow for quick action. However, this system does test for a more limited number of HDs.
Best practice recommendations are to utilize both types of testing. Testing can be regularly conducted for a comprehensive list of HDs in order to build a broad-based picture of HD exposure risk in the facility. Simultaneously, the rapid testing can serve to deliver additional data, such as the effectiveness of a given cleaning practice, in a timely fashion.
ChemoGlo and BD continue to enjoy the lion’s share of this marketplace. The Other category includes a number of facilities that either rely on their certifier to conduct testing or use fluorescein dye and solution testing in lieu of true wipe sampling to monitor staff competency with handling HDs.
Determine the best testing frequency for your facility. Regular, repeated testing is key to creating an accurate picture of HD residue in your facility. While USP <800> recommends a frequency of at least every 6 months, consider what we have learned with environmental monitoring in the cleanroom; that is, a higher frequency means more data points, and thus a more accurate picture of your facility’s HD exposure risk.
No cleaning process can be consistently perfect. In addition to the human factor risks affecting the execution of cleaning practices, there are the inherent complications to deactivating a given surface. Wipe analysis serves as an additional early warning system for determining when cleaning processes require an adjustment, be it a refresh of staff training or more frequent product rotation.
To determine sampling locations, consider areas with high volumes of HD contact, as well as sites of previous spills. Clearly, the various work surfaces and storage sites within the hazardous cleanroom are candidates. But it is important to expand beyond these and consider room door handles, storage areas on the oncology units, infusion chairs, and smart pump buttons. Also, consider testing the exterior of HD shipping containers as well as the exterior of drug waste containers.
Deanne Halvorsen is the editorial director and founding partner of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and MedicalLab Management. She can be reached at firstname.lastname@example.org.
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