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Trends in USP <800> Compliance
December 2018 : USP <800> - Vol. 15 No. 12

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting some 800-compliant practices; for example, most facilities already segregate their HD inventory from non-HDs in storage. However, other recommended practices are far from widespread; for example, few hospital pharmacies conduct HD spill simulations and wipe analyses on a regular basis. As such, many facilities do not have a firm understanding of the impact of HD contamination in their facility, nor can they be assured that their staff will respond properly when an HD spill inevitably occurs.

Pharmacy is fully aware of their need to change practices (and in some cases upgrade facilities) in order to achieve <800> compliance. Only 8% of facilities are confident that they are currently compliant.


HD unpacking typically takes place in a neutral or negative pressure area; 78% of all facilities conduct their unpacking under these conditions. Just 10% of facilities are unpacking in a positive pressure environment.

Totals exceed 100% as some facilities have multiple unpacking areas.


Three-quarters of all facilities separate and segregate HDs from non-HDs in storage, and that number is projected to reach 91% by the December 1, 2019 deadline.


HD SPILLS

Just 71% of hospital pharmacies have designated their HD compounding areas as authorized access only. In fact, all HD handling areas must be restricted to authorized personnel only, and signage must be prominently displayed. Furthermore, these areas should be sited to discourage any inadvertent access or exposure to anyone not trained in HD handling; for example, do not locate HD areas near a break room or refreshment area.


A variety of products are available for decontaminating engineering controls following an HD spill; the most commonly utilized are Contec’s PeridoxRTU and Covidien’s Surface Safe. One out of every 10 facilities mixes their own solution using bleach, sodium thiosulfate, and detergent.


WIPE ANALYSIS

Ideally, wipe analysis should be conducted on a regular basis both to demonstrate the effectiveness of training and cleaning/decontamination efforts, and to pinpoint any developing trends. While 44% of those facilities conducting wipe analysis do take this approach, 36% have conducted a one-time analysis only. A single analysis does provide baseline data; however, not following up with regular wipe tests enfeebles the value of this initial data.


Regular wipe analysis is more commonly conducted in facilities with 200+ beds.


Most wipe analysis is conducted either on the engineering controls where the HDs are compounded or on the floor of the HD compounding room. Consider wiping less obvious spots; should contamination be recorded on elevator buttons or at the nurses’ desk, for example, such data provides a strong impetus for process change. 

Note: Totals exceed 100% as most facilities test multiple sites.

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