Revisions to the 2009 American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards: Expanding the Scope to Include Inpatient Settings

The ASCO/ONS Chemotherapy Administration Safety Standards were reviewed to address interim changes in practice and make needed modifications. The most significant change is to extend their scope to the inpatient setting.

Abstract

In November 2009, ASCO and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

Introduction

In 2008, ASCO and the Oncology Nursing Society (ONS) initiated a collaborative project to develop standards for safe chemotherapy administration. The project targeted adult patients receiving parenteral and oral chemotherapy in outpatient settings, with a principal focus on patient safety. The end result was the publication of the ASCO/ONS Chemotherapy Administration Safety Standards in 2009.^1,2 Subsequently, both organizations received feedback from their membership and other stakeholders asking for clarification of several standards. In addition, the ASCO-based Quality Oncology Practice Initiative (QOPI) Certification Program, which, as part of its assessment, evaluates outpatient oncology practices regarding their ability to meet 17 safety standards derived from the ASCO/ONS standards, received similar queries.

In January 2011, ASCO and ONS convened a workgroup to review the ASCO/ONS Chemotherapy Safety Standards and the feedback that both organizations had received since publication. Questions had been raised about the interpretation of several standards and the exclusion of the inpatient setting in the initial standards. This article reviews the process that led to the development of the initial chemotherapy safety standards, the process undertaken to review and revise them (Appendix Table A1, online only), and the rationale for the changes that were made.

Standards Development Process

In 2008, volunteer leaders and staff from ASCO and ONS formed a steering group (SG) to develop safety standards for outpatient chemotherapy administration. The SG identified experts from a diverse, multidisciplinary group of stakeholders and invited them to attend a workshop to draft the standards. SG members compiled a synopsis of relevant literature and guidelines, a reference list, and full-text key articles, which were sent to workshop participants in advance of the December 2008 workshop.

Forty stakeholders, including medical oncologists, oncology nurses, oncology pharmacists, social workers, practice administrators, and patient advocates, as well as representatives from American Cancer Society, Association of Community Cancer Centers, National Quality Forum, National Coalition for Cancer Survivorship, The Joint Commission, and Institute for Safe Medication Practices met for a single day and, using a structured process, drafted 64 chemotherapy administration safety standards. The draft standards were subsequently presented to the full group of participants for comment and discussion, and assessed for redundancy and gaps. Participants voted on the draft standards within 1 week of the workshop, and the SG used the voting results to clarify and edit the standards, reducing their number to 35. The draft standards were then disseminated to all ASCO and ONS members and electronically posted for public comment as a Web-based survey. Three hundred twelve respondents provided comments and voted (yes/no) to include each standard. Ten additional responses were made directly to ASCO or ONS. Most standards received “yes” votes from the majority of respondents (range, 82% to 96%). The number of narrative comments on individual standards ranged from eight to 76. Many of the comments were simple requests for clarification or rewording suggestions. After the close of the 6-week public comment period (January 29 to March 13, 2009), the SG reviewed the comments and voting results, evaluated all of the standards with less than 90% “yes” votes, and modified language as needed to adequately address issues raised in the open comments. This process resulted in four of the standards being eliminated. The final 31 standards were approved by the SG in April 2009, approved by ASCO and ONS, published online ahead of print in ASCO's Journal of Clinical Oncology¹ on September 28, 2009, and reprinted with permission in the November 2009 ONS publication Oncology Nursing Forum.²

Standards Review Process

In January 2011, a workgroup was assembled by ASCO and ONS to review and, when indicated, revise the ASCO/ONS Chemotherapy Administration Safety Standards. The eight-member workgroup consisted of the original project chairs from ASCO and ONS (Joseph O. Jacobson MD, and Martha Polovich, PhD, RN, AOCN), and representatives from ASCO, ONS, and the QOPI Certification Program. In advance of the meeting, the workgroup received a summary list of questions and comments about the standards that had been received by ONS, ASCO, and the QOPI Certification Program, along with reference articles and other supporting documentation.

The workgroup reviewed the criteria that were used when the standards were initially developed, concurred that the criteria remained current and applicable, and agreed to use them to guide the standards revision discussion (Table 1). All 31 standards were reviewed. Each standard, along with associated questions and comments, was reviewed, and changes or clarifications were made by majority vote. Only standard 16 required substantive change (see below). After a final review, the workgroup unanimously approved the modifications to the standards. In addition, the workgroup recommended that the ASCO/ONS Chemotherapy Administration Safety Standards apply across all treatment settings. The revised standards were then reviewed and approved by the ASCO Executive Committee and the ONS Board of Directors.

Table 1.

Criteria for Developing Final Standards

Final standards should comply with the following criteria

Applicable to diverse organizations providing outpatient chemotherapy to adult cancer patients

Focused on patient safety

Focused on site policies and procedures, and the process of planning for and administering chemotherapy, rather than facility/physical plant characteristics

Apply to each outpatient site administering chemotherapy, unless otherwise specified

Address parenteral and oral chemotherapy regimens

Appropriate for use for internal and external safety monitoring

Compliance with standards, as written, should be measurable

Standard language should be clear enough to ensure reliable, consistent interpretation among users and sites

Final standards in each component should include at least one focused on patient/caregiver teaching

NOTE. This set of criteria should be used in group deliberation to guide and focus discussion concerning the statements in each component of the standards.

Public comment was solicited during a 4-week period from July 12, 2011 to August 11, 2011 by using a Web-based survey (Zarca Interactive, Herndon, VA). After introductory text that explained that public comment was sought on the revised standards as applicable to the extension of their scope to the inpatient setting, 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 applicability to the inpatient setting and provided relevant comments. ASCO and ONS members were notified of the opportunity for public comment via existing member communications, and targeted e-mails were sent to relevant groups and committees including National Cancer Institute, National Comprehensive Cancer Network, Commission on Cancer, Institute for Safe Medication Practices, and The Joint Commission. After close of the public comment period, the workgroup reviewed voting results and all open text comments.

Revisions and Clarifications

The most significant change to the ASCO/ONS Chemotherapy Administration Safety Standards was in response to clinicians who questioned why the initial standards were designated for the outpatient setting only. In 2008, to limit scope, the Chemotherapy Administration Safety Standards were explicitly designed to apply only to the outpatient setting, where the majority of patients receive chemotherapy. To determine the feasibility of expanding the standards to the inpatient setting, the workgroup reviewed each of the 31 standards to determine its applicability and appropriateness to the inpatient setting. All were deemed to apply, and the workgroup unanimously approved the proposal to make the standards applicable to the inpatient setting by means of the following change: the scope of the standards was changed from “outpatient” (defined as any non-inpatient treatment setting, with the exclusion of home infusion services) to “all chemotherapy treatment settings.”

During the public comment period, 87 individuals responded to the request to vote on whether or not each of the 31 chemotherapy administration safety standards was applicable to the inpatient setting. Agreement for individual standards ranged from 79% to 100%, with only two standards deemed applicable to the inpatient setting by less than 90% of the respondents. Eighty two percent of respondents agreed that standard 20, “a licensed independent practitioner is on site and immediately available during all chemotherapy administration,” was applicable to the inpatient setting. Concern focused on the availability of a licensed independent practitioner on site and immediately available, especially during nights, holidays, and weekends. The workgroup reviewed the definition of “licensed independent practitioner,” which is defined as “physicians, advanced practice nurses (nurse practitioner or clinical nurse specialist), and/or physician assistants, as determined by state law.”¹ Given the broad definition, the workgroup concluded that meeting standard 20 in inpatient settings is feasible.

Standard 25, “the practice/institution establishes a procedure for documentation and follow-up for patients who miss office visits and/or treatments” was deemed applicable to the inpatient setting by 79% of respondents. Respondents who did not support this standard for use in the inpatient setting viewed this as an outpatient oncology responsibility. To enhance clarity, the workgroup revised the wording of standard 25 to, “the practice/institution establishes a procedure for documentation and follow-up for patients who miss office visits and/or scheduled treatments.” The language changes are intended to more clearly identify responsibility for inpatient providers.

Several respondents inquired why safe handling of chemotherapy was not addressed in the ASCO/ONS Chemotherapy Administration Safety Standards or their revision. Although none of the standards specifically address this issue, ASCO and ONS endorse the safe handling of chemotherapy agents. Published guidelines define the expectations for organizations related to the use of safe handling precautions.^3–7 Education, training, and competency validation for chemotherapy administration must necessarily include this aspect of practice. Organizations must focus on a “culture of safety,” because of the relationship between patient and health care workers' safety.^3,4

The majority of changes to the chemotherapy administration standards required minor wording changes to enable a standard to pertain to the inpatient setting. An example is the requirement to sign a printed version of a verbal chemotherapy “stop” or “hold” order within a designated time frame in accordance with organizational policy.

In keeping with the expanded setting focus, the language of some of the standards required modification. For instance, standard 1 was previously worded as, “The practice has policies, procedures, and/or guidelines for verification of training and continuing education for clinical staff,” and is now worded, “The practice/institution has policies, procedures, and/or guidelines for verification of training and continuing education for clinical staff.” Revisions involved changing the term “clinic visit” to “treatment day” so that the revised standards apply to any treatment setting where chemotherapy is administered. Similarly, any mention of “practice staff” was changed to “staff.”

Standard 2 addresses the requirement for documentation of key patient, disease, and chemotherapy details. The current wording, “Before prescribing a new chemotherapy regimen, chart documentation available to the prescriber includes …” was amended to, “Before the first administration of a new chemotherapy regimen, chart documentation available to the practice/institution includes …” The rationale for the change is that safe chemotherapy administration requires a team of professionals (physicians, nurses, pharmacists, others) and, therefore, chart documentation should be available not only to the prescriber but to all members of the treatment team (eg, pharmacists, nurses, etc).

Previously, standard 2F (initial psychosocial assessment) and standard 22 (ongoing psychosocial assessment) required “assessment regarding psychosocial concerns and need for support.” Wording for these two standards was amended to add “with action taken when indicated,” because acting on psychosocial assessment findings, when warranted, promotes patient safety, coping, and comfort.^5,6

Drug preparation standard 12 previously stated that “A second person independently verifies each order for chemotherapy before preparation, including confirming: two patient identifiers, drug names, drug dose, drug volume, rate of administration, route of administration, and the calculation for dosing, including the variables used in this calculation.” An additional item, “cycle and day of cycle,” was added to this list of requirements as a safety measure to reduce the risk of timing errors that could potentially result in the patient receiving less than, or more than, the intended amount of chemotherapy.

Standard 13 states that chemotherapy drugs are labeled immediately on preparation and lists the information that must appear on the label. Previously, the standard required that the date and time of preparation and expiration appear on the label. This standard was revised to require that the date and time of preparation must appear on the label; date and time of expiration are required only when chemotherapy is not planned for immediate use (defined as per practice policy and state regulations). This change was made to reduce the risk of an error resulting from two sets of dates and times on chemotherapy labels.

The original language of standard 16 stated, “Informed consent for chemotherapy must be documented by a physician in the practice before chemotherapy administration.” Subsequent to the publication of the standards, the workgroup learned that practice patterns vary from state to state and that chemotherapy consent is frequently obtained by advanced practice nurses or other clinical staff. For the revised standards, the workgroup removed the word “physician” from the requirement. This retains the essential intent of the standard—that informed consent for chemotherapy is necessary—without stipulating how consent is documented.

Standard 31 previously stated, “The practice has a process for risk-free reporting of errors or near misses. Error and near miss reports are reviewed and evaluated at least semiannually.” The standard was revised to, “The practice/institution encourages the reporting of errors and near misses and has a formal process in place for evaluating the data. Error and near-miss reports are reviewed and evaluated at least semiannually.” The words “risk-free” were deleted in recognition that although most events are due to systems failures, some are due to individual decisions or actions for which there must be personal accountability. Clinicians who disregard policies and procedures, for instance, are accountable for their actions when errors occur.^7–9

Observed variations in interpretation and clinical implementation of several standards prompted the need for further clarification. For example, standard 1F states that “all clinical staff maintains current certification in basic life support.” Some practices inquired whether this standard applies to physicians, especially in states where cardiopulmonary resuscitation (CPR) certification is optional for physicians under state law. The workgroup affirmed that “all clinical staff” includes physicians and that CPR certification enhances safety in settings where chemotherapy is administered.

For some standards, minor wording changes clarify their intent. Standard 22 was originally worded, “At each clinical visit during chemotherapy administration, practice staff assess and document in the medical record ….” This was amended to, “At each clinical visit or day of treatment during chemotherapy administration ….” This change more precisely describes the frequency of patient assessment in any setting, such as inpatient or home care. Standard 24 was previously phrased as, “The practice maintains a referral list for psychosocial and other supportive care services.” The workgroup agreed that “maintaining a list” limited the intent and amended the wording to, “The practice/institution maintains referral resources for psychosocial and other supportive care services.” The revised language encourages organizations to meet this standard in a variety of ways, such as having support personnel (eg, social workers) available to patients, offering support groups and counseling or providing information about these services, referring patients to online or community programs and resources, and so on.

The workgroup recognized that some of the standards are more challenging to implement for oral chemotherapy. Given the increasing use of oral chemotherapeutic agents and the expected FDA approval of multiple new oral agents, the workgroup concluded that oral chemotherapy safety must be addressed, and that the task was beyond the scope of the current project. In addition, the workgroup recognized that the current standards do not adequately address medication reconciliation for nononcologic agents. Chemotherapeutic agents and other medications prescribed by oncologists frequently interact with non–cancer-related medications. Because cancer is primarily a disease of aging adults who often have multiple comorbidities and are taking multiple medications; patients receiving chemotherapy are at particular risk of drug-drug interactions that could result in drug toxicity. Finally, the workgroup acknowledged that chemotherapy delivered by infusion services in the home setting presents unique safety issues not fully addressed by the current standards. These topics were deemed beyond the scope of the current workgroup.

Discussion

When they were developed in 2008, the ASCO/ONS Chemotherapy Safety Standards reflected the consensus of a broad group of stakeholders. The standards were intended to assist oncology practices in creating the safest possible processes for chemotherapy administration. It was understood at the time of their publication that they would require periodic revision. The closing sentence of the Standards publication reminded us that “regular review of these standards will be needed as the practice of medical oncology continues to evolve rapidly.”¹

Although the inpatient setting was not explicitly addressed by the original standards, there is now strong consensus among the members of the workgroup that this is an area of potential vulnerability for our patients. Advances in the delivery of chemotherapy coupled with the ability to better manage toxicities have resulted in a shift of oncology care from the inpatient to the outpatient setting over the last decade. The result for many hospitals has been a reduction in the number of oncology inpatients and a concomitant reduction in the number of experienced chemotherapy staff available to reliably administer chemotherapy.¹⁰ The implications for patient safety are significant. The authors recognize that implementation of the standards in the inpatient setting will be challenging, requiring collaboration between medical oncologists and hospital administration.

The unique risks inherent in the prescription and administration of oral chemotherapy have become clearer since publication of the standards.^11,12 Practices and practitioners have far less ability to directly manage the care of patients who receive oral chemotherapy. This awareness, in conjunction with the rapid increase in the availability of novel oral agents, led to the recommendation to undertake an independent process to create oral chemotherapy safety standards. ASCO and ONS have convened a separate oral chemotherapy safety workgroup that is charged with the responsibility of creating usage guidelines; identifying potential performance measures; and providing final recommendations to modify the existing ASCO/ONS standards, if warranted. In addition, ASCO and ONS recognize the need for defined processes for medication reconciliation and home chemotherapy administration.

As we did previously, we encourage clinicians in all practice settings to assess their compliance with the revised standards. Accomplishing this goal will require close collaboration between medical oncologists, oncology nurses, oncology pharmacists, and cancer program and hospital administrators. Given the many regulatory and economic pressures on organizations, oncology healthcare providers must make a compelling case for the implementation of the standards. Ensuring that these standards are implemented in all settings will promote safe chemotherapy administration for patients with cancer.

The revised ASCO/ONS Chemotherapy Safety Standards can be found at www.asco.org/chemostandards.

Appendix

Table A1.

American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards

Common Definitions for ASCO/ONS Chemotherapy Administration Safety Standards
Term	Definition
Chemotherapy	All antineoplastic agents used to treat cancer, given through oral and parenteral routes or other routes as specified in the standard. Types include targeted agents, alkylating agents, antimetabolites, plant alkaloids and terpenoids, topoisomerase inhibitors, antitumor antibiotics, monoclonal antibodies, and biologics and related agents. Hormonal therapies are not included in the definition of chemotherapy for the standards.
Chemotherapy regimen	One or more chemotherapeutic agents used alone or in combination in a well-defined protocol, generally administered cyclically
Practitioner	Licensed independent practitioner, including physicians, advanced practice nurses (nurse practitioner or clinical nurse specialist), and/or physician assistants, as determined by state law
Chemotherapy setting (site)	All chemotherapy treatment settings (inpatient and outpatient)
Staffing-related standards
1. The practice/institution has policies, procedures, and/or guidelines for verification of training and continuing education for clinical staff.
A. Orders for parenteral and oral chemotherapy are written and signed by licensed independent practitioners who are determined to be qualified by the practice/institution according to the practice's/institution's policies, procedures, and/or guidelines.
B. Chemotherapy drugs (oral or parenteral) are prepared by a pharmacist, pharmacy technician, or nurse determined to be qualified according to the practice's policies, procedures, and/or guidelines.
C. Only qualified physicians, physician assistants, advanced practice nurses, or registered nurses administer chemotherapy.
D. The practice/institution has a comprehensive educational program for new staff administering chemotherapy, including a competency assessment, or the practice/institution uses an off-site educational program regarding chemotherapy administration that ends in competency assessment. Chemotherapy administration education must include all routes of administration used in the practice/institution site (eg, parenteral, oral, intrathecal, intraperitoneal, intravesicular).
An example of an off-site educational program is the ONS Chemotherapy and Biotherapy Course.
E. The practice/institution has a standard mechanism for monitoring chemotherapy administration competency at specified intervals.
Annual competency reassessment is recommended.
F. All clinical staff maintains current certification in basic life support.
Certification should be from a nationally accredited course. Clinical staff includes all staff involved in patient care: RNs, MDs, NPs, etc.
Chemotherapy planning: chart documentation standards
2. Prior to the first administration of a new chemotherapy regimen, chart documentation available to the practice/institution includes:
A. Pathologic confirmation or verification of initial diagnosis
If original pathology report is unobtainable, note of explanation is in chart or a reference to primary source pathology.
This standard does not imply the need to rebiopsy if not clinically necessary.
B. Initial cancer stage or current cancer status
Cancer stage is defined at diagnosis. Cancer status includes a current description of the patient's disease since diagnosis/staging, if relevant (eg, recurrence, metastases).
C. Complete medical history and physical examination that includes, at minimum, height, weight, and assessment of organ-specific function as appropriate for the planned regimen
Example of assessment of organ-specific function as appropriate for the planned regimen: patient plan for cisplatin requires pretreatment assessment of kidney function.
D. Presence or absence of allergies and history of other hypersensitivity reactions
E. Documentation of patient's comprehension regarding chemotherapy regimens (and associated medications), including information regarding disease
F. Assessment regarding psychosocial concerns and need for support, with action taken when indicated
Documentation of psychosocial concerns may include copy of distress, depression, or anxiety screening form in the chart; patient self-report of distress, depression, or anxiety; or chart documentation regarding patient coping, adjustment, depression, distress, anxiety, emotional status, family support and care giving, coping style, cultural background, and socioeconomic status.
G. The chemotherapy treatment plan, including, at minimum, chemotherapy drugs, doses, anticipated duration, and goals of therapy
H. For oral chemotherapy, the frequency of office visits and monitoring that is appropriate for the individual and the antineoplastic agent and is defined in the treatment plan
General chemotherapy practice standards
3. The practice/institution:
A. Defines standard chemotherapy regimens by diagnosis with references readily available, and/or
B. Identifies source(s) for chemotherapy regimens, including local or centralized institutional review board–approved clinical research protocols or guidelines
4. For orders that vary from standard chemotherapy regimens, practitioners provide a supporting reference. Reasons for dose modification or exception orders are documented.
Exception orders may include notation that standard treatment is contraindicated as a result of pre-existing comorbidity, organ dysfunction or prior therapy.
5. The practice/institution maintains written statements that determine the appropriate time interval for regimen-specific laboratory tests that are:
A. Evidence based when national guidelines exist (eg, ASCO or National Comprehensive Cancer Network guidelines), or
B. Determined by practitioners at the site
Documentation of regimen-specific laboratory tests may be part of standardized regimen orders.
6. The practice/institution maintains a policy for how informed consent is obtained and documented for chemotherapy.
The practice/institution may provide options for consent (eg, use of chart documentation of patient consent or a signed patient consent form) that allow for variation among practitioners in the practice/institution.
7. If the practice/institution administers chemotherapy that is prepared (mixed) off site, the practice/institution maintains a policy for quality control of that chemotherapy.
Chemotherapy order standards
8. The practice/institution does not allow verbal orders except to hold or stop chemotherapy administration. New orders or changes to orders must be made in writing.
Fax and e-mail orders are considered written orders.
9. The practice/institution maintains and uses standardized, regimen-level preprinted or electronic forms for parental chemotherapy prescription writing.
Standardized forms may be incorporated into e-prescribing software or electronic health records.
10. Order forms inclusively list all chemotherapy agents in the regimen and their individual dosing parameters. All medications within the order set are listed using full generic names and follow Joint Commission standards regarding abbreviations.
Brand names should be included in orders only where there are multiple products or when including the brand name otherwise assists in identifying a unique drug formulation.
Complete orders must include:
A. Patient's full name and a second patient identifier (eg, medical record number, DOB)
B. Date
C. Diagnosis
D. Regimen name and cycle number
E. Protocol name and number (if applicable)
F. Appropriate criteria to treat (eg, based on relevant laboratory results and toxicities)
G. Allergies
H. Reference to the methodology of the dose calculation or standard practice equations (eg, calculation of creatinine clearance)
I. Height, weight, and any other variables used to calculate the dose
J. Dosage
Doses do not include trailing zeros; use a leading zero for doses <1 mg.
K. Route and rate (if applicable) of administration
L. Length of infusion (if applicable)
M. Supportive care treatments appropriate for the regimen (including premedications, hydration, growth factors, and hypersensitivity medications)
N. Sequence of drug administration (if applicable)
Practices/institutions are not expected to be in full compliance with this standard if they currently have electronic ordering systems that prevent compliance. Appropriate changes should be implemented as soon as possible to ensure that electronic ordering systems integrate all of these elements. If the information cannot be captured in the electronic system, it should be documented within the patient record.
11. Orders for parenteral/oral chemotherapy should be written with a time limitation to ensure appropriate evaluation at predetermined intervals.
Drug preparation
12. A second person (a practitioner or other personnel approved by the practice/institution to prepare or administer chemotherapy) independently verifies each order for chemotherapy before preparation, including confirming:
A. Two patient identifiers
B. Drug names
C. Drug dose
D. Drug volume
E. Rate of administration
F. Route of administration
G. Calculation for dosing (including the variables used in this calculation)
H. Treatment cycle and day of cycle
13. Chemotherapy drugs are labeled immediately upon preparation, including, at minimum:
A. Patient's full name and a second patient identifier (eg, medical record number, DOB)
B. Full generic drug name
C. Drug administration route
D. Total dose to be given
E. Total volume required to administer this dosage
F. Date of administration
G. Date and time of preparation
H. Date and time of expiration when not for immediate use
Immediate use must be defined by institutional policy, state, and federal regulations (eg, use within 2 h).
Practices/institutions are not expected to be in full compliance with this standard if they currently have electronic systems that are unable to meet these labeling requirements. Appropriate changes should be implemented as soon as possible to ensure that electronic labels integrate all of these elements.
14. Practices/institutions that administer intrathecal medication maintain policies specifying that intrathecal medication will:
A. Not be prepared during preparation of any other agents
B. Be stored, once prepared, in an isolated container or location with a uniquely identifiable intrathecal medication label
C. Be delivered to the patient only with other medication intended for administration into the CNS
Patient consent and education
15. Before initiation of a chemotherapy regimen, each patient is given written documentation, including, at minimum:
A. Information regarding his/her diagnosis
B. Goals of therapy
C. Planned duration of chemotherapy, drugs, and schedule
D. Information on possible short- and long-term adverse effects
E. Regimen-or drug-specific risks or symptoms that require notification and emergency contact information, including:
1. How to contact the practice or organization
2. Symptoms that should trigger a call
3. Who should be called in specific circumstances (oncologist or other provider)
F. Plan for monitoring and follow-up
Patient education materials should be appropriate for the patient's reading level/literacy and patient/caregiver understanding.
16. Informed consent for chemotherapy must be documented prior to initiation of a chemotherapy regimen.
The consent process should follow appropriate professional and legal guidelines. (For more information and sample forms, seehttp://www.asco.org/consent.)
17. All patients who are prescribed oral chemotherapy are provided written or electronic patient education materials about the oral chemotherapy before or at the time of prescription.
A. Patient education includes the preparation, administration, and disposal of oral chemotherapy.
B. The education plan includes family, caregivers, or others based on the patient's ability to assume responsibility for managing therapy.
Patient education materials should be appropriate for the patient's reading level/literacy and patient/caregiver understanding.
Chemotherapy administration
18. Before chemotherapy administration:
A. Confirm with the patient his/her planned treatment prior to each cycle
B. At least two practitioners or personnel approved by the practice/institution to prepare or administer chemotherapy verify the accuracy of:
1. Drug name
2. Drug dose
3. Drug volume
4. Rate of administration
5. Route of administration
6. Expiration dates/times, if applicable (expiration date/time is not required if for immediate use)
Immediate use must be defined by institutional policy, state, and federal regulations (eg, use within 2 h).
7. Appearance and physical integrity of the drugs
C. Document to indicate verification was done and
D. At least two individuals, in the presence of patient, verify the patient identification using at least two identifiers (eg, medical record number, DOB)
19. Extravasation management procedures are defined and align with current literature and guidelines; antidote order sets and antidotes are accessible.
20. A licensed independent practitioner is on site and immediately available during all chemotherapy administration.
In organizations or home care settings where chemotherapy may be administered 24/7, patients/caregivers should be explicitly educated in procedures for unplanned events and circumstances.
Monitoring and assessment
21. The practice/institution maintains protocols for response to life-threatening emergencies, including escalation of patient support beyond basic life support.
It is recommended that emergency protocols be reviewed annually.
22. On each clinical visit or day of treatment during chemotherapy administration, staff:
A. Assess and document clinical status and/or performance status
B. Document vital signs and weight
C. Verify allergies, previous reactions, and treatment-related toxicities
D. Assess and document psychosocial concerns and need for support, taking action when indicated.
This standard applies to all clinical encounters (including each inpatient day, practitioner visits and chemotherapy administration visits, but not laboratory or administrative visits).
23. At each clinical visit or day of treatment during chemotherapy administration, staff review the patient's current medications, including over-the-counter medications and complementary and alternative therapies. Any changes in the patient's medications are reviewed and documented by a practitioner during the same visit.
This standard applies to all clinical encounters (including each inpatient day practitioner visit and chemotherapy administration visits, but not laboratory or administrative visits).
24. The practice/institution maintains referral resources for psychosocial and other supportive care services.
25. The practice/institution establishes a procedure for documentation and follow-up for patients who miss office visits and/or scheduled chemotherapy treatments.
26. The practice/institution evaluates and documents treatment-related toxicities using standard definitions or criteria selected by that practice/institution.
Examples include NCI Common Toxicity Criteria and WHO Toxicity Criteria.
27. The practice/institution has policies and procedures that identify:
A. A process to provide 24/7 triage to a practitioner (eg, on-call practitioner, emergency department) for care of toxicities
B. Consistent documentation and communication of toxicity across sites of care within the practice/institution (if applicable)
Each practice/institution/team must have a tracking system in place that can guarantee safe handoff of care between all sites of care.
28. Toxicity assessment documentation is available for planning subsequent treatment cycles.
29. The practice/institution has a process to track cumulative doses of chemotherapy agents associated with a risk of cumulative toxicity.
30. The practice/institution uses standard, disease-specific processes to monitor treatment response (eg, use of evaluations, laboratory results, or scans/imaging) that are based on published literature/guidelines or are determined by the practice/institution.
31. The practice/institution encourages the reporting of errors and near misses and has a formal process in place for evaluating the data. Error and near-miss reports are reviewed and evaluated at least semiannually.

NOTE. These consensus standards, related to patient safety for chemotherapy administration, were originally developed jointly by ONS and ASCO for use in the ambulatory/outpatient setting. The current version reflects modifications agreed upon by ASCO and ONS which are intended to clarify the original intent of the standards and to allow for their application in inpatient settings. The standards are intended to reflect current thinking on best practices and, as such, are intended to be a “living” document; future modifications are expected. Although none of the ASCO/ONS standards specifically address this issue, ASCO and ONS endorse the safe handling of chemotherapy agents. Published guidelines define the expectations for organizations and health care workers related to the use of safe handling precautions (American Society of Health System Pharmacists: Am J Health Syst Pharm 63:1172-1193, 2006; National Institute for Occupational Safety and Health: DHHS Publication No. 2004-165, http://www.cdc.gov/niosh/docs/2004-165, 2004; Occupational Safety and Health Administration: OSHA technical manual, http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html, 1995; Polovich M, et al: Pittsburgh, PA, Oncology Nursing Society, 2009; U.S. Pharmacopeial Convention, Rockville, MD, 2008). Education, training, and competency validation for chemotherapy administration must necessarily include this aspect of practice. Organizations should focus on a culture of safety, because of the relationship between patient and HCW safety (Friese CR, et al: BMJ Qual Saf, doi: 10.1136/bmjqs-2011-000178, 2011; Polovich M, et al: Oncol Nurs Forum, in press). The standards are not deemed comprehensive and do not account for individual patient variation. It is the responsibility of each administering agent to determine the best methods for chemotherapy administration for each patient. The standards are not medical advice or legal advice. To the extent that the standards conflict with applicable federal, state, or local legal requirements, practitioners should comply with those requirements. The administering agent is solely responsible for, and assumes all risks of, administering chemotherapy drugs notwithstanding any adherence to the standards herein. ASCO and ONS disclaim any and all liability with respect to the standards and the execution of the standards by any party.

Abbreviations: DOB, date of birth; ONS, Oncology Nursing Society; NCI, National Cancer Institute; NP, nurse practitioner; RN, registered nurse.

Authors' Disclosures of Potential Conflicts of Interest

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a “U” are those for which no compensation was received; those relationships marked with a “C” were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: Terry R. Gilmore, American Society of Clinical Oncology (C); Kristine B. LeFebvre, Oncology Nursing Society (C) Consultant or Advisory Role: Lisa Schulmeister, ASCO QOPI Certification Program (C); Peg Esper, ASCO QOPI Certification Program (C) Stock Ownership: None Honoraria: None Research Funding: None Expert Testimony: None Other Remuneration: None

Author Contributions

Conception and design: Joseph O. Jacobson, Martha Polovich, Terry R. Gilmore, Lisa Schulmeister, Peg Esper, Kristine B. LeFebvre, Michael N. Neuss

Administrative support: Terry R. Gilmore, Kristine B. LeFebvre

Collection and assembly of data: Martha Polovich, Terry R. Gilmore, Lisa Schulmeister

Data analysis and interpretation: Joseph O. Jacobson, Martha Polovich, Terry R. Gilmore, Lisa Schulmeister, Peg Esper, Kristine B. LeFebvre, Michael N. Neuss

Manuscript writing: Joseph O. Jacobson, Martha Polovich, Terry R. Gilmore, Lisa Schulmeister, Peg Esper, Kristine B. LeFebvre, Michael N. Neuss

Final approval of manuscript: Joseph O. Jacobson, Martha Polovich, Terry R. Gilmore, Lisa Schulmeister, Peg Esper, Kristine B. LeFebvre, Michael N. Neuss