November 2009, Volume 36, Number 6
Open Access Article
American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards
Joseph O. Jacobson,
MD, MSc, Martha Polovich, MN, RN, AOCN®, Kristen K. McNiff, MPH,
Kristine B. LeFebvre, MSN, RN, AOCN®, Charmaine Cummings, PhD, RN, Michele Galioto, RN, MSN, Katherine R. Bonelli, BS, and Michele R. McCorkle, RN, MSN
Standardization of care can reduce the risk of errors, increase efficiency, and provide a framework for best practice. In 2008, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) invited a broad range of stakeholders to create a set of standards for the administration of chemotherapy to adult patients in the outpatient setting. At the close of a full-day structured workshop, 64 draft standards were proposed. After a formal process of electronic voting and conference calls, 29 draft standards were eliminated, resulting in a final list of 35 draft measures. The proposed set of standards was posted for 6 weeks of open public comment. Three hundred twenty-two comments were reviewed by the Steering Group and used as the basis for final editing to a final set of standards. The final list includes 31 standards encompassing seven domains, which include the following: review of clinical information and selection of a treatment regimen; treatment planning and informed consent; ordering of treatment; drug preparation; assessment of treatment compliance; administration and monitoring; assessment of response and toxicity monitoring. Adherence to ASCO and ONS standards for safe chemotherapy administration should be a goal of all providers of adult cancer care.
Administration of antineoplastic agents is a complex process fraught with the potential for patient harm. Challenges to patient safety grow as the number of chemotherapeutic regimens expands and oral chemotherapy drugs become commonplace. Despite safety risks, there are few national standards for safe administration—especially in the outpatient adult oncology setting. Providers of outpatient cancer care services are among the stakeholders seeking guidance to achieve the best, safest outcomes of therapy. To meet this need, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) initiated a collaborative project in 2008 to develop standards for safe chemotherapy administration to adult cancer patients in the outpatient setting. The scope of the project was limited to patient safety and included both parenteral and oral chemotherapy regimens.
Although few true standards exist, a body of literature published over the past decade informed the ASCO/ONS effort. The two organizations, as well as other professional associations, developed guidelines or recommendations to improve the quality and safety of chemotherapy administration in a variety of settings.1-3 The ASCO position statement, published in 2004, outlines minimum-level criteria for safe practice and recognized that most chemotherapy is administered in outpatient settings. Guidelines developed by the ONS and the American Society of Health-System Pharmacists offered comprehensive recommendations, such as safe handling of chemotherapy agents. Late in the development process of the ASCO/ONS standards, the Clinical Oncological Society of Australia published recommendations for safe prescribing, supply, and administration of chemotherapy that address the roles of various practitioners.4
Recommendations to improve safety and increase the quality of chemotherapy administration also have been developed in response to reports of chemotherapy administration errors.5-9 Recent studies have specifically addressed medication errors in outpatient chemotherapy administration settings.10,11 Recommendations for avoiding chemotherapy administration errors call for standardized approaches, development of policies and procedures for system improvement, and review of errors by interdisciplinary professional staff. 7-9,12,13
In addition, increased use of electronic medical record systems may lead to improvement in the safety and quality of outpatient chemotherapy administration. E-prescribing, for example, may prove to be a tool for reducing errors in chemotherapy ordering. Some electronic systems prompt clinicians in a practice to specify standard, evidence-based regimens to be used for specific diagnoses. Automated systems can reduce errors in regimen selection in a busy clinical setting.14,15
Oral chemotherapy agents pose new safety challenges. Adherence is a formidable issue in oral chemotherapy administration; poor adherence has been reported to have a substantial impact on the success of chemotherapy and patient safety.16-18 The National Comprehensive Cancer Network established a task force to explore the impact of increasing use of oral chemotherapy. They concluded that safety issues stem from a lack of checks and balances in administration, risk of patient noncompliance, lack of monitoring techniques, and a shift to patient management of oral chemotherapy.16 Despite the need for increased patient education regarding oral chemotherapy and processes to monitor adherence and adverse events, few standards regarding education or monitoring have been developed.17,19-21
This article reports on the ASCO/ONS development and consensus process and the resulting standards for safe chemotherapy administration in hematology/oncology ambulatory care settings.
With the goal of developing chemotherapy administration safety standards using a multidisciplinary, consensus-building process, an ASCO/ONS Steering Group of volunteer leaders and staff was assembled in the summer of 2008. The Steering Group chose to reach consensus of final standards by use of a structured workshop, open public comment period, and systematic review of collated data. Steering Group members further defined the scope of the project as pertains to the components of chemotherapy administration illustrated in Figure 1.
The Steering Group selected experts among diverse stakeholders for representation at the workshop, where standards were to be drafted. Appropriate experts were identified by Steering Group members, publications, and recommendations from professional societies. Before the workshop, Steering Group members conducted a literature review and prepared a synopsis of relevant published guidelines and recommendations, a reference list, and full text of key articles. These documents were distributed to workshop participants in advance of the meeting, along with introductory materials regarding the goals, scope, and common definitions. Workshop participants were informed that drafted standards should comply with the stated scope and meet specified criteria (Table 1).
The workshop was convened in December 2008, with 40 participants including medical oncologists, nurses, pharmacists, social workers, practice administrators, and patient advocates. A complete list of workshop participants is posted at http://www.asco.org/safety and http://www.ons.org/clinical/. Standards were discussed, reviewed, and revised by the workshop participants in small breakout sessions. Scribes recorded the standards, which then were presented to the full group of participants for further comment and discussion. The standards were assessed for redundancy and gaps. Finally, workshop participants were asked to vote on the draft standards within 1 week of the meeting. Voting results and subsequent review and editing by the Steering Group for redundancy resulted in the public comment standards draft.
Public comment was accomplished using a Web-based survey, Zarca (Zarca Interactive, Inc, Herndon, VA). After introductory text that provided common definitions for all standards, each standard was listed separately for voting. The survey tool collected two demographic characteristics of the respondents, primary profession and primary practice setting. For each of the draft standards, respondents voted (yes/no) for inclusion in the final set and provided relevant comments.
The public comment period was 6 weeks (January 29 to March 13, 2009). ASCO and ONS members were notified of the opportunity for public comment via existing member communications and targeted e-mails to relevant groups and committees. Workshop participants were asked to advertise the public comment using their own Web sites and/or communication tools.
After close of the public comment, the Steering Group reviewed voting results and all open text comments. Steering Group members especially evaluated all standards with less than 90% yes votes and assessed whether edits could adequately address issues raised in the open comments. Some draft standards were considered to be goals and were removed from the final standards list.
Workshop participants defined 64 draft standards during the 1-day meeting. On the basis of results of workshop participants’ voting and comments, Steering Group members developed a public comment document comprising 35 public comment draft standards. The common definitions developed to apply to all standards are listed in Table 2.
Three hundred twenty-two responses were received after the request for public comment over the 6-week period. The online survey netted 312 responses, and 10 additional responses were made directly to ASCO or ONS. Table 3 lists the primary profession and practice setting of the survey respondents.
The online survey presented each proposed standard with the question, “Should this standard be included in the final set?” Response options were “Yes” or “No.” The results were recorded as frequencies and percentages of yes and no votes. Most standards received yes votes from the majority of respondents, with a range of 82% to 96%. Comments about each standard were also recorded. The number of comments varied from eight to 76 on individual standards. Many comments were requests for clarification or suggestions for rewording, whereas others were statements for or against individual proposed standards.
The Steering Group reviewed all of the survey data, including the comments, both individually and collectively. The final standards were evaluated for redundancy, revised, and agreed on by the Steering Group in April 2009. Table 4 lists the final 31 standards.
Moving medicine from a craft-based era to a profession-based field depends on the willingness to adopt principles that transformed industry in the 20th century.37 In addition to the need for enhanced teamwork, decision support tools, and performance measurement, common practices and procedures must be standardized if care is to be as safe and efficient as possible. Uniform approaches to diagnosis and treatment have become commonplace in many medical specialties. For example, adherence to the use of a simple checklist prior to the placement of a central catheter in the critical care setting results in improved outcomes.38 Because of the complexity of chemotherapy administration and the risk of severe adverse effects, standardizing care in settings where chemotherapy is delivered is essential.
The current article represents a successful collaboration between ASCO and ONS and provides a series of consensus-derived safety standards that are intended to provide a basis for the safe administration of outpatient chemotherapy to adult cancer patients. Standards were defined based on a structured and iterative process that included an open public comment period. We defined a standard as an expectation of care based on well-defined criteria (Table 1). Nearly half of the draft standards were eliminated during the review process either because they were duplicative or did not meet all of the required criteria. The final set of standards is applicable to all outpatient oncology settings; however, it is known that not all practices will be able to achieve all standards immediately on publication.
Development by consensus with public comment was a new process for ASCO and ONS. Both organizations used existing member and public communication mechanisms to publicize the call for public comments, as well as targeted outreach. Additionally, development workshop participants were asked to advertise the public comment using their Web sites/communication tools. There are limitations to the public comment approach. It is unknown how representative the survey respondents are of the membership of ASCO or ONS or of the population of medical oncologists and oncology nurses in the United States in general. In addition, the number of respondents was small compared with the entire membership of either organization. ONS has approximately 37,000 members, and ASCO has more than 27,000. Physicians were under-represented in public comment; however, ASCO/ONS Steering Group members learned that physicians often delegated response to the survey to nurses or others on staff. Ultimately, the comments received reflected many of the diverse professionals involved in chemotherapy administration, as well as patient advocacy groups.
During public comment period, the ASCO/ONS Steering Group learned of the newly published Guidelines for the Safe Prescribing, Dispensing and Administration of Cancer Chemotherapy from the Clinical Oncological Society of Australia.4 Although the two efforts had different goals and reflect different systems of care, there is significant overlap, and each validates the other.
How should the ASCO/ONS chemotherapy administration safety standards be used? Of importance, the standards are voluntary but represent consensus across a broad range of stakeholders. We suggest that medical oncology practice staff assess their own compliance with each of the standards. For areas requiring improvement, practice members should prioritize time and resources and set achievable goals. To help practices rapidly comply with the standards, ASCO and ONS will provide tools and resources to assist in practice implementation (http://www.asco.org/safety and http://www.ons.org/clinical/). Once compliance has been maximized, practices should create a mechanism for periodic surveillance.
Regulators, payers, and patient advocacy groups have growing influence on the provision of cancer care. Oncology specialty societies are well positioned to respond to these groups by defining and disseminating best practices and standards of care, helping to create an environment of transparency, and creating tools for measuring the components of care. The ASCO/ONS chemotherapy administration safety standards are the result of a successful collaboration led by oncology providers, with broad input from diverse stakeholders. Regular review of these standards will be needed as the practice of medical oncology continues to evolve rapidly.
We acknowledge all of the workshop participants, who volunteered their time and expertise to developing the initial draft standards (for a full list, go to http://www.asco.org/safety). We also acknowledge the hundreds of reviewers and commenters who contributed during the public comment period.
ASCO/ONS Standards for Safe Chemotherapy Administration Workshop Participants
Joseph O. Jacobson, MD, MSc
Martha Polovich, MN, RN, AOCN®
Terri Ades, MS, FNP-BC, AOCN®
Sylvia Bartel, RPh, MPH
Thomas Beck, MD
Douglas Blayney, MD
Katherine R. Bonelli, BS
Susan D. Coples, RN, BSN, OCN®
Charmaine Cummings, PhD, RN
Marybeth Farquhar, PhD, MSN, RN
Michele Galioto, RN, MSN
Kimberly George, MSN, RN, ACNS-BC, OCN®
J. Russell Hoverman, MD, PhD
Deborah Kamin, PhD
Michael Kulczycki, MBA
Kristine B. LeFebvre, MSN, RN, AOCN®
Gail A. Mallory, PhD, RN, NEA-BC
Michele R. McCorkle, RN, MSN
Kristen K. McNiff, MPH
Michael N. Neuss, MD
Kim Noonan, RN, NP, AOCN®
Cindy L. O’Bryant, PharmD, BCOP
Patti O’Donnell, PhD, LICSW
Mikaela Olsen, RN, MS, OCN®
Ann H. Partridge, MD
Cindy Paul, RN, OCN®
Bela Sastry, MPH
Lisa Schulmeister, RN, MN, APRN-BC, OCN®, FAAN
Ann D. Shastay, RN, MSN, AOCN®
Lawrence Shulman, MD
Ronald Walters, MD, MBA, MHA, MS
Mary Wilkinson, MD
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Joseph O. Jacobson, MD, MSc, is the chairman of medicine at North Shore Medical Center and an associate clinical professor of medicine at Harvard Medical School, both in Salem, MA; Martha Polovich, MN, RN, AOCN®, is an associate director of clinical practice at Duke Oncology Network in Durham, NC; Kristen K. McNiff, MPH, is the director for quality in Cancer Policy and Clinical Affairs at the American Society of Clinical Oncology (ASCO) in Alexandria, VA; Kristine B. LeFebvre, MSN, RN, AOCN®, is a project manager at the Oncology Nursing Society (ONS) in Pittsburgh, PA; Charmaine Cummings, PhD, RN, is the assistant director for quality in Cancer Policy and Clinical Affairs at ASCO; Michele Galioto, RN, MSN, is the director of education at ONS; Katherine R. Bonelli, BS, is a program coordinator in the QOPI® Certification Program at ASCO; and Michele R. McCorkle, RN, MSN, is the executive director of corporate support and partnerships at ONS. This research was supported by the American Society of Clinical Oncology and the Oncology Nursing Society. McNiff can be reached at Kristen.firstname.lastname@example.org, with copy to editor at ONFEditor@ons.org.
Digital Object Identifier: 10.1188/09.ONF.651-658