Working with Nursing to Ensure USP <800> Compliance

February 2017 : Oncology Safety - Vol.14 No. 2 - Page #4
Categories: Closed System Drug-Transfer Devices (CSTDs), PPE/Garb & Gloves

Q&A with Seth Eisenberg, RN, OCN, BMTCN

Pharmacy Purchasing & Products: What are the most significant challenges for ensuring nursing compliance with USP <800>, and how can pharmacy assist in this endeavor?

Seth Eisenberg: The first challenge is ensuring that nursing staff is aware of USP <800> Hazardous Drugs—Handling in Healthcare Settings.1 While most nurses are familiar with the Oncology Nursing Society (ONS) guidelines for safe handling of hazardous drugs (HDs),2 and to varying degrees the National Institute for Occupational Safety and Health (NIOSH) guidelines for preventing occupational exposure to antineoplastic and other HDs in health care settings,3 USP remains an unknown entity. Given hospital pharmacies’ familiarity with USP, particularly with implementing USP Chapter <797>, pharmacy leaders should network with their nursing colleagues to develop USP <800> education that is pertinent for nurses.4 While many USP <800> requirements focus on pharmacy-centric activities, the chapter also covers HD administration, which is highly relevant to nursing practice, both in oncology and non-oncology settings.

Gaining nursing buy-in for USP <800> compliance is requisite to implementing practice change. One way to reduce trepidation and resistance to change on the part of nursing is to ensure that nurses understand the rationale for the changes, as well as the consequences for noncompliance. For example, the use of proper personal protective equipment (PPE), the importance of which has been clear for several decades, still presents a challenge for many organizations, particularly smaller practices that may not be following the NIOSH guidelines. However, because USP <800> is enforceable while the NIOSH guidelines are not, these organizations will need to make changes to avoid being cited.

Specific areas of USP <800> compliance that are relevant for nursing include the following:

  • Staff Education. One potentially challenging component of USP <800> compliance requires that all nurses who handle HDs receive education prior to drug administration. While such education is typical on oncology units, ensuring appropriate staff education can be a more significant challenge on hospital units where HDs are given for non-oncologic purposes, and with non-chemotherapy HDs (eg, ganciclovir). Nursing education should take into account both state and USP <800> requirements, as more states enact their own legislation on HD safety.
  • Implement Closed System Drug-Transfer Devices (CSTDs). CSTD adoption will be a major practice change for organizations that currently do not utilize a device. Implementing a CSTD requires a careful evaluation of the different CSTDs on the market, keeping in mind the varying methods of administering intravenous HDs. Thus, CSTD use can have a dramatic effect on the current nursing workflow. Because CSTDs will likely also be utilized by pharmacy—although USP <800> recommends but does not require CSTDs be used for compounding—establish a multidisciplinary HD workgroup to enhance collaboration and prevent isolated decision-making regarding CSTDs.
  • Use of Compliant PPE. The use of gowns for HD administration has historically been significantly less prevalent than glove use; a dramatic shift in the safety culture will be necessary to ensure compliance with this USP <800> requirement. Some outpatient facilities have allowed staff to reuse gowns, which is not permitted by USP <800>. The type of gowns used must be scrutinized, as not all gowns marketed for chemotherapy administration meet the requirements of USP <800>. (For more information, see PP&P’s January 2015 article, Are Gloves and Gowns Safe for Handling Chemotherapy?)

While double gloving is not a new concept, it has rarely been enforced. Estimates vary, but surveys indicate that less than 20% of nurses are consistently double gloving when handling HDs.5 Wearing a second pair of chemotherapy-tested gloves will be a challenge for many nurses and will likely represent the biggest source of resistance. USP <800> also requires that both pairs of gloves be chemotherapy-tested; some organizations that are currently double gloving are doing so with thinner, non-chemotherapy gloves. Inviting staff who administer HDs to sample different brands of chemotherapy-tested gloves can aid in fostering compliance.

PP&P: How should an organization develop and implement a comprehensive strategy for USP <800> compliance?

Eisenberg: Compliance challenges will be different for each hospital and health care system. The first step is to perform a comprehensive gap analysis to determine which practices are currently meeting the standards and which are not. Engaging nursing experts, including those nurses practicing at the bedside, can help identify areas in need of improvement. Clinical nurse specialists, nursing educators, and department managers must all be on the same page to efficiently and effectively assess a facility’s needs. A number of checklists are available to assist an organization in determining where the most significant gaps exist and in developing a course of action to remedy these issues, including Joint Commission Resources’ Self Assessment of Safe Handling Practices for Hazardous Drugs (available at, and the CriticalPoint USP <800> Gap Analysis Tool (available at

PP&P: How should an organization determine which issues to address first?

Eisenberg: Once a gap analysis has been completed, begin the task of triaging the noncompliant practices, identifying challenges that can be worked on simultaneously, and evaluating which issues will require the most significant resources. While one group may be trialing CSTDs, another group can simultaneously examine PPE options, and still another group can develop an organization-wide education plan.

A comprehensive USP <800> compliance strategy will require proper planning and a commitment to devoting sufficient resources—neither of which can wait until just before the July 2018 deadline for compliance.

PP&P: What USP <800> compliance challenges may be encountered in settings outside of the hospital: clinics, outpatient pharmacies, and physicians’ practices?

Eisenberg: While there are exceptions, historically, oncology practices outside of larger hospital settings have been more lackadaisical in regard to HD safety. Smaller rural hospitals, clinics, and private practices that may not see large volumes of oncology patients or use a large volume of HDs will likely have the greatest compliance challenges. Some of these facilities may not currently provide basic PPE for nurses, or may have nurses compounding HDs with minimal safety equipment. The financial burden of becoming compliant—particularly in regard to compounding—may be cost-prohibitive for some practices. Partnering with neighboring organizations or other private practices may help in cost management and resource sharing.

PP&P: How can environmental wipe sampling for HD surface contamination be used to document that cleaning and disinfection practices are adequate and that a CSTD is effective?

Eisenberg: While wipe sampling is not required by USP <800>, there is tremendous value in performing routine testing. Surface sampling can provide information about whether the safety equipment is performing to the level of expectation. A wipe test before and after CSTD implementation, with proper decontamination in between, can demonstrate the effectiveness in the device’s ability to reduce or eliminate exposure. This, in turn, provides positive feedback to staff using the device—the enhanced safety is now quantifiable and helps justify the added expense and time that may be required for CSTD use. Surface testing can also assist in evaluating the effectiveness of cleaning and decontamination of surfaces, both in the pharmacy and in all areas after a spill.


  1. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. Accessed January 19, 2017.
  2. Polovich M, ed. Safe Handling of Hazardous Drugs. 2nd ed. Oncology Nursing Society; 2011.
  3. NIOSH Alert. Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. DHHS (NIOSH) Publication Number 2004-165, September 2004. Accessed January 19, 2017.
  4. USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Accessed January 19, 2017.
  5. Boiano JM, Steege AL, Sweeney MH. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. J Occup Environ Hyg. 2014;11(11):728-740.

Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has worked in the field of oncology since 1983. His experience includes 30 years in hematopoietic stem cell transplantation.


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