What is USP <800>?
Pharmacists and technicians involved with compounding are well acquainted with the United States Pharmacopeia [USP]. Nurses however, have historically not been familiar with this nonprofit scientific organization. USP sets standards for medication quality, and issues National Formulary chapters containing standards for compounding non-sterile and sterile medications. (See figure 1). USP General Chapter 797, (abbreviated with the “less than” and “greater than” symbols) is concerned with sterile compounding. USP <800>, released in February 2016, provides specific standards on HD safety which includes administration and required education. This is the first time that a pharmacy-centric organization is mandating specific HD requirements for nurses.
Figure 1. Guidelines vs Standards
HD guidelines for nurses are not new; ONS has been the prominent leader in providing best practice and evidence-based recommendations since the early 1980s. Many of the recommendations are based on work done by NIOSH and ASHP, and to a lesser degree, OSHA. But with the exception of OSHA, (which has historically not made HD safety a national priority), none of the aforementioned organizations have enforcement abilities. Thus, guidelines are considered best practice recommendations and not requirements.
However, because of USP’s relationship with the FDA, CMS and each states Board of Pharmacy, their standards are enforced (Polovich, 2017). The Joint Commission (TJC), while not officially commenting on whether USP <800> will become part of their surveys, has supported the chapter by through the Joint Commission Resources, creating a comprehensive HD toolkit, along with updates in their newsletters. Therefore it is anticipated that surveyors will be looking at compliance issues.
The implication for healthcare facilities should not be underestimated. For although USP itself does not enforce its standards, inspections by the above agencies revealing compliance issues can result in serious consequences.
What does USP <800> cover?
While USP originally charged for the chapter, USP <800> is now a free downloadable PDF from the USP website. On some levels, the 19-page chapter is well-organized and quite specific. Divided into 18 topic areas, the chapter leans heavily on its pharmacy-centric roots, and information specifically for nurses are interwoven into the sections that also apply to pharmacy-based routines. This organizational schema does create some confusion, but makes sense in order to avoid repeating material that applies to both the pharmacy and nursing activities.
Alas, there are also nursing-specific areas that are absent, such as handling of excreta and linens, and interoperative procedures (e.g., HIPEC and ophthalmologic surgery). Hopefully future updates to the chapter will include this information.
The nursing-specific content aligns with the current 2019 ONS guidelines. Examples include:
CSTDs for administration of antineoplastic HDs.
Proper PPE for administration and disposal, which includes 2 pairs of ASTM 6978 (or its successor) tested gloves and an HD-resistant gown with long sleeves, elastic or knit cuffs, and fully closed in the front.
Proper respiratory protection for spills.
Mandatory education for all employees who handle HDs, occurring prior to handling, and with competency validation at least every 12 months.
Avoiding manipulation of HDs (e.g., crushing tablets).
Written confirmation for all personnel of reproductive capability that they understand the risks of handling HDs.
Section 15 (DEACTIVATING, DECONTAMINATING, CLEANING, AND DISINFECTING) targets compounding and provides both guidance and confusion for administering HDs. Appropriate deactivation protocols for a biologic safety cabinet cannot be successfully extrapolated to a 15,000 square foot Infusion department. The issue is complicated by the limitation of products currently available for this purpose. (See discussion on the deactivation dilemma for additional information.) USP <800> also includes recommendations on surface wipe testing and medical surveillance. More information on wipe testing can be found here.
USP <800> will be effective December 1, 2019. Though it is unlikely inspections will begin on this date, we never know when a survey will occur, or when an agence arrives due to an employee complaint.
A number of resources are available to assist organizations in becoming compliant with USP <800>. In addition to the Joint Commission Resource toolkit mentioned above, a series of free educational videos are available here. In addition to the videos, a free checklist can be downloaded from the site. Other gap analysis tools are available as well.