USP Chapter <800> was finalized and published on February 1, 2016 with an extended official implementation date of July 1, 2018 (although some states have elected to require earlier compliance). Unlike Chapter <797>’s focus on enhancing patient safety, Chapter <800> is intended primarily to protect healthcare workers and environments from exposure to hazardous drugs (HDs) in the healthcare settings where they are handled. It is important to note that many of the requirements and recommendations in Chapter <800> are not new, and a wide variety of professional sources such as the American Society of Health-System Pharmacists, American Society of Clinical Oncology, National Institute for Occupational Safety and Health, and the Oncology Nursing Society have provided similar recommendations since the 1980s.1-5 Since much of this information has long been available, we must ask why it has taken so long to commit to implementing these sensible recommendations—some of which are now requirements. While there are many reasons (and excuses) for previous delays, Chapter <800> now mandates enforcement of these regulations, which will lead to many overdue physical plant modifications and work practice alterations.
Critical Point examined compliance with Chapter <800> as part of the 2016 USP Compliance Study. This year’s study findings establish a practice baseline for HD practices. As you review the findings on the following pages, keep in mind that the reported compliance rates are likely to be somewhat overstated. Because completion of the Chapter <800> Gap Tool (offered as part of the 2016 USP Compliance Study) is optional, those participating in the study are likely to be aware of pending regulatory requirements and be motivated to comply. It is also possible for survey respondents to interpret questions differently based on their experiences. The innate desire to view our practices—and hence ourselves—in a favorable light also is likely to cause an inflation in self-reported compliance scores, especially when contemplating compliance with regulations that serve to ensure the safety of our staff.
Here are a few thoughts on how to get on the road to Chapter <800> compliance:
Although achieving compliance with the standards in USP Chapter <800> may appear to be a daunting undertaking, the roadmap to any operational and regulatory challenge begins with an understanding of where you are today and where you need to be at each ensuing critical step in order to achieve full compliance. Compliance is a journey, not a destination. Develop a compliance plan that is strategic and based upon your organization’s needs. Systematically evaluate the voyage traveled by HDs in your facility. Verify current containment strategies and develop new ones. Learn from the experience of others. A wealth of information is available to support your efforts. Each step you take gets you closer to your goal and more importantly, moves your organization another step closer to compliance.
Right now, that is all we can ask. Move forward. Get started. What do you have to lose?
Kate Douglass, MS, RN, CRNI, is the vice president of CriticalPoint, LLC, and serves as the co-director of the annual USP Compliance Survey.
Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and principal of Clinical IQ, LLC, and CriticalPoint, LLC. He also serves as the co-director for the annual USP Compliance Survey.
Peter Cantor, who serves as the COO and managing partner of CriticalPoint, LLC, is the study coordinator.
Address any questions to Kate Douglass at firstname.lastname@example.org.
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