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Preventive Ethics: Addressing Ethics Quality Gaps on a Systems Level Article in Joint Commission journal on quality and safety · March 2012 DOI: 10.1016/S1553-7250(12)38014-8 · Source: PubMed
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The Joint Commission Journal on Quality and Patient Safety Performance Measures
Preventive Ethics: Addressing Ethics Quality Gaps on a Systems Level Mary Beth Foglia, RN, PhD, MA; Ellen Fox, MD; Barbara Chanko, RN, MBA; Melissa M. Bottrell, PhD, MPH
T
he following case-study vignette illustrates staff concerns about an organization’s informed-consent process:*
A busy endoscopy clinic integrates the informed consent process into the immediate pre-procedure work flow. Upon arriving at the clinic, patients are provided with an oral anxiolytic and asked to change into hospital gowns. They are assisted onto a gurney and transferred to a procedure room where nursing staff begin to prep them for the procedure. The physician joins the patient in the procedure room, reviews the informed consent form, answers the patient’s questions and obtains their signature. Next, the patient is sedated and the procedure is initiated. While the clinical team agrees that the process of obtaining informed consent is efficient, they worry that the process is inconsistent with promoting voluntary decision making by their patients. One nurse said that he personally would have a hard time changing his mind, once he was “gowned, gurneyed, and drugged.”
“Preventive Ethics” (PE) is a key component of IntegratedEthics (IE), an innovative model developed by the Veterans Health Administration’s National Center for Ethics in Health Care which establishes a comprehensive, systematic, integrated approach to ethics. Based on established principles of continuous quality improvement and proven strategies for organizational change, IE is designed to improve ethics quality at all levels of a health care organization.1,2 The IE model was developed and refined in more than a five-year period by a design team [including the authors], representing diverse fields—bioethics, nursing, medicine, public administration, business, education, communications, and social sciences. The design team used a rigorous consensus development process that included literature reviews across multiple fields of study and input from internal and external stakeholders. IE structures, methods, and tools were systematically evaluated through validity testing, field testing, and a 12-month demonstration project in 25 health care facilities. Since early * The examples and case-study vignettes in this article are inspired by and reflect the collective health care experience of the authors, both within and external to the Department of Veterans Affairs, and do not represent any single and actual event.
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Article-at-a-Glance Background: Preventive ethics (PE) is a key component of IntegratedEthics (IE), an innovative model developed by the Department of Veterans Affairs National Center for Ethics in Health Care, which establishes a comprehensive, systematic, integrated approach to ethics in health care organizations. Since early 2008, IE has been implemented throughout all 153 medical centers and 21 regional networks within the VA health care system. ISSUES: A Step-by-Step Approach to Ethics Quality Improvement: PE employs a systematic, step-by-step process improvement approach called “ISSUES”—that is, Identify an issue, Study the issue, Select a strategy, Undertake a plan, Evaluate and adjust, and Sustain and spread. After the ethics quality gap is described, a measureable and achievable improvement goal based on the gap is developed. One of the most challenging aspects of describing an ethics quality gap is to establish an appropriate ethical standard on which to base the operational definition of best ethics practice. Practical Steps to Developing a Preventive Ethics Function: Within the VA’s IE model, PE is situated as a subcommittee of the IE council, which is chaired by the facility director (equivalent to a hospital chief executive officer) and oversees all aspects of the organization’s ethics program, including ethical leadership, ethics consultation, and PE. Each VA medical center is required to have a PE team led and managed by a PE coordinator and may need to address ethics issues across the full range of health care ethics domains. Conclusions: The VA’s IE model establishes a robust conceptual framework, along with concrete tools and resources, to integrate PE concepts into the day-to-day operations of a health care organization and is directly transferrable to other health care organizations and systems.
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The Joint Commission Journal on Quality and Patient Safety 2008, IE has been implemented throughout all 153 medical centers and 21 regional networks within the US Department of Veterans Affairs (VA) health care system. The model is being continuously expanded and improved as new resource materials are added over time. A host of both national and international organizations are adopting IE, in part or in whole. For example, Kaiser Permanente’s Southern California Region has built the IE approach into its business plan for its 14 facilities. Full-time ethicists in each facility lead ethics consultation and ethics QI efforts based on IE tools. The Advisory Office of the Ministry of Education of Taiwan has adopted the IE ethics consultation materials for use throughout the country. The Health Ministry of British Columbia’s Provincial Forum for Clinical Ethics Support and Coordination has endorsed IE and committed to stepwise implementation of the ethics consultation, preventive ethics, and ethical leadership functions of IE in the province. Catholic Health Care Partners (Cincinnati) has adopted the IE preventive ethics component to address cross-cutting ethics issues. Duquesne University (Pittsburgh) has developed a 12-credit clinical rotation curriculum for doctoral students in which students implement the three functions of IE; IE concepts are also taught in master’s degree and graduate certificate programs. In addition, in 2011 the Ash Center for Democratic Governance and Innovation of Harvard’s John F. Kennedy School of Government identified IE as one of the Top 25 innovative programs in American government.3 As reported elsewhere, PE, along with other aspects of IE, was created in response to identified shortcomings in traditional ethics programs. Specifically, traditional programs tend to be reactive, responding to ethical concerns on a case-by-case basis, while the root cause of these concerns remains unexamined and largely invisible.2,4 Consequently, similar ethical concerns tend to recur, resulting in avoidable ethical missteps, moral distress, waste and rework, and poor stewardship of limited institutional ethics resources. In contrast, PE is proactive and systems oriented, routinely looking “upstream” for factors that cause or contribute to ethical concerns, and intervening to prevent future recurrences. This article first provides a conceptual overview of PE, including its purpose, scope and assumptions. Next, it focuses in on the concept of an ethics quality gap, which is at the heart of the PE model. Finally, it outlines the practical steps that are necessary to implement a PE function within a health care organization.
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The term preventive ethics, first introduced in the bioethics literature in 1993, was used to describe “explicit, critical reflection on the institutional factors that influence patient care.”5(p. 291) Since then, the term has been used in a variety of contexts to emphasize the importance of systems thinking and how organizational factors influence ethical practices. The IE model builds on these notions by explicitly defining PE as “activities performed by an individual or group on behalf of a health care organization to identify, prioritize, and address systemic ethics issues.”2(p.15) Further, IE establishes a robust conceptual framework for PE as well as concrete structures and methods to operationalize the concept. Fundamental to the IE model and PE activities is the concept that ethics is integral to health care quality. A health care provider who fails to meet established ethical standards is not delivering high quality care—even if the standards that relate to other dimensions of health care quality, such as technical or service quality, are met. Conversely, a failure to meet minimum quality standards raises ethical concerns. Thus, health care ethics and health care quality cannot be separated.2 The IE version of PE applies the principles and practices of continuous quality improvement to identify and address ethics quality gaps at the level of an organization’s systems and processes.2 Thus, the central focus of PE is to reduce unjustifiable variation in ethical practices—thereby improving overall “ethics quality” within an institution. PE, similar to other systematic QI approaches, reduces variation by identifying and intervening on aspects of an organization’s systems and processes that contribute to and sustain ethics quality gaps. PE is designed to improve ethical practices across the full range of ethical concerns that arise in health care management and delivery. The IE model categorizes these concerns into nine health care ethics content domains, as follows2: ■ Shared decision making with patients ■ Ethical practices in end-of-life care ■ Ethical practices at the beginning of life ■ Patient privacy and confidentiality ■ Professionalism in patient care ■ Ethical practices in resource allocation ■ Ethical practices in business and management ■ Ethical practices in the everyday workplace ■ Ethical practices in research Within the VA, two additional domains are used (ethical practices in government service and the IE program), and topics are defined for each domain (Table 1, page 105). For example, the domain “shared decision making with patients” includes the topics of decision-making capacity/competency, informed consent process, surrogate decision making, advance care plan-
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The Joint Commission Journal on Quality and Patient Safety Table 1. VA IntegratedEthics Health Care Ethics Domains and Topics* IntegratedEthics Domains Shared Decision Making with Patients
Ethical Practices in End-of-Life Care
Description How well the organization promotes collaborative decision making between clinicians and patients
Topics ■ Decision making capacity/competency: ability of the patient to make his or her own health care decisions ■ Informed consent process: providing information to the patient or surrogate, ensuring that the decision is voluntary, and documenting the decision is voluntary, and documenting the decision ■ Surrogate decision making: selection, role, and responsibilities of the person authorized to make health care decisions for the patient ■ Advance care planning: statements made by a patient with decision-making capacityregarding future health care decisions ■ Limits to patient choice: for example, choice of care setting, choice of provider, a demand for unconventional treatment ■ Other
How well the organization addresses ethical aspects of caring for patients near the end of life
■ Cardiopulmonary resuscitation (CPR): withholding or stopping resuscitation in the event of cardiopulmonary arrest,
including do-not-resuscitate (DNR) or do not attempt resuscitation (DNAR) orders ■ Life-sustaining treatments: withholding or stopping artificially administered fluid or nutrition, mechanical ventilation,
dialysis, surgery, antibiotics, etc. ■ Medical futility: a clinician’s judgment that a therapy will be of no benefit to a patient and therefore should not be
offered or should be withdrawn ■ Hastening death intentionally or unintentionally: for example, questions relating to euthanasia, assisted suicide, or the doctrine of double effect ■ Death and postmortem issues: determination of death, organ donation, autopsy, disposition of body or tissue, etc. ■ Other Patient Privacy and Confidentiality
How well the organization protects patient privacy and confidentiality
■ Privacy: protecting individuals’ interests in maintaining personal space free of unwanted intrusions and in
Professionalism in Patient Care
How well the organization fosters employee behavior appropriate for health careprofessionals
■ Conflicts of interest: situations that may compromise the clinician’s fiduciary duty to patients, including inappropriate
How well the organization demonstrates fairness in allocating resources across programs, services, and patients
■ Systems level—macro-allocation: how well the facility demonstrates fairness in allocating resources across
Ethical Practices in Business and Management
How well the organization promotes high ethical standards in its business and management practices
■ Leadership: behaviors of leaders in support of an ethical environment and culture
Ethical Practices in Government Service
■ Government ethics rules and laws: ethics rules, regulations, policies or standards of conduct that apply to federal How well the organization fosters behavior appropriate government employees, for example, bribery, nepotism, gift and travel rules for government employees ■ Other
Ethical Practices in Research
How well the organization ensures that its employees follow ethical standards that apply to research practices
■
Ethical Practices in the Everyday Workplace
How well the organization supports ethical behavior in everyday interactions in the workplace
■ Respect and dignity:
IntegratedEthics Program
How well the organization achieves the program standards of the IntegratedEthics model
■
Ethical Practices in Resource Allocation
controlling data about themselves ■ Confidentiality: nondisclosure of information obtained as part of the clinician-patient relationship ■ Other
business or personal relationships ■ Truth telling: open and honest communication with patients, including disclosing bad news and adverse events ■
Difficult patients: clinician interactions with patients who are disruptive or do not adhere to treatment plans/health care recommendations ■ Cultural/religious sensitivity: clinician interactions with people of different ethnicity, religion, sexual orientation, gender, age, etc. ■ Other programs and services ■ Individual level—micro-allocation: how well the facility demonstrates fairness in allocating resources to individual
patients or staff ■ Other ■ Human resources: supervisory support for an ethical environment and culture through the performance management system ■ Business integrity: practices that support oversight of business processes, compliance with legal and ethical standards, and promotion of business quality and integrity ■ Other
Informed consent for research: providing information to the research subject or surrogate, ensuring that the decision is voluntary, and documenting the decision
employee privacy, personal safety, respect for diversity
■ Ethical climate: for example, openness to ethics discussion, perceived pressure to engage in unethical conduct ■ Other
IntegratedEthics structures and processes: characteristics and policies of the organization’s formal mechanisms for addressing ethics in health care
* VA, U.S. Department of Veterans Affairs.
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The Joint Commission Journal on Quality and Patient Safety ning, and limits to patient choices. The list of domains and topics of health care ethics helps PE teams to clarify and communicate about the scope of their activities and provides a means of tracking the types of ethics issues addressed over time.
Assumptions Behind Preventive Ethics Three key assumptions informed the development of PE within the IE model. First, PE is necessary because ethics consultation is not well suited to address systems-level obstacles to ethical practices. The goal of ethics consultation is to address uncertainty or conflict about values by responding to a specific ethics question, such as “Given that the patient wishes to extend his life against all odds, but the attending physician believes resuscitating the patient in the event of cardiac arrest is futile, is it ethically justifiable for the physician to write a do-not-resuscitate order over the patient’s objection?” Ethics consultants engage in ethics analysis to determine which decision or action is “right” (that is., ethically appropriate) in a particular instance. PE, on the other hand, is oriented to understanding why the “right” practice is not occurring consistently and then applying systems-level solutions to improve practice. Consider the following example: An ethics consultation service documented repeated consults related to values conflicts between clinicians and surrogates regarding medical treatment decisions for patients who lacked decision-making capacity. A root cause analysis of the ethical concerns by the PE team revealed that the cause(s) of these recurrent consults included that there were no processes to (a) provide for the timely identification of surrogate decision makers, (b) ensure that surrogate decision makers understood their role with respect to making treatment decisions, or (c) prime clinicians to engage surrogates early and often in care planning. After processes were developed to improve practice in each of these three areas and standardized as part of routine operations, the number of ethics consultations involving clinician-surrogate conflicts decreased dramatically.
A second assumption informing PE is that ethical behavior within organizations is powerfully influenced by the organization’s systems and processes.6–11 Thus, ethical missteps have roots in not only the fallibility of humans but also in flawed organizational systems and processes.12–17 PE aims to improve systems and processes to the extent that strong ethical practices become reflexive or inevitable. For example: The process of obtaining informed consent for surgical procedures was found to vary widely depending on the surgical procedure and the surgical team. A closer examination found that even for the same procedure, there was considerable variation in what information surgeons communicated to patients. A root cause analysis by the PE
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team revealed that surgeons did not understand the standards for informed consent, did not agree about which risks and benefits were important to share with patients, and did not have access to high quality patient education materials to support patient understanding. The organization remedied these gaps by implementing an electronic informed consent process. Informed consent documents now include standardized information, developed by a consensus panel involving clinical experts, about the purpose, risks, benefits, and alternatives to the procedure (ethically necessary aspects of informed consent), as well as standardized patient education materials. The results are that surgeons consistently engage in higher quality informed consent discussions, and patients are measurably more satisfied and express greater confidence that they have the information they need to make informed decisions about their health care.
Finally, a third assumption is that ethical practices in health care can be operationalized, measured, and consequently improved. Measurement distinguishes PE from many other ethics program activities within health care organizations. Consider this example: In reviewing the results from the IntegratedEthics Staff Survey (an assessment tool that measures staff perceptions of ethical practices within their institution), the PE team noted that 90% of acute care staff perceived that medical students are almost never explicitly introduced as students— which is an ethical concern because it allows patients to draw the mistaken conclusion that they are being cared for by a fully fledged medical doctor. The PE team validated this impression by attending morning rounds with the health care team for a week. Of 100 observations, medical students were explicitly introduced as students 15 times. Following a small scale test of various change strategies, a repeat observation found that medical students introduced themselves as students 95% of the time, an increase of 80% over baseline.
ISSUES: A Step-by-Step Approach to Ethics Quality Improvement In an effort to measurably improve ethical practices, PE employs a systematic, step-by-step process improvement approach called “ISSUES.” ISSUES is an acronym that stands for the following: Identify an issue Study the issue Select a strategy Undertake a plan Evaluate and adjust, and Sustain and spread. Each of these six steps of ISSUES in turn contains three substeps (Table 2, page 107). The ISSUES approach is described in detail in Part III of a IE primer18 and in an accompanying video with the same name (both of which are available for free online). ISSUES is similar to other QI frameworks, but importantly, it differs in that it is customized to focus on ethics quality gaps.
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The Joint Commission Journal on Quality and Patient Safety Table 2. Preventive Ethics ISSUES Approach to Addressing Ethics Quality Gaps IDENTIFY an Issue ■ Identify ethics issues proactively ■ Characterize the type of issue ■ Clarify each issue by listing the improvement goal STUDY the Issue ■ Diagram the process behind the relevant practice ■ Gather specific data about best practices ■ Gather specific data about current practices ■ Refine the improvement goal to reflect the ethics quality gap SELECT a Strategy ■ Identify the major cause(s) of the ethics quality gap—do a root cause analysis ■ Brainstorm about possible strategies to narrow the gap ■ Choose one or more strategies to try UNDERTAKE a Plan ■ Plan how to carry out the strategy ■ Plan how to evaluate the strategy ■ Execute the plan EVALUATE and Adjust ■ Check the execution and the results ■ Adjust as necessary ■ Evaluate your ISSUES process SUSTAIN and Spread ■ Sustain the improvement ■ Disseminate the improvement ■ Continue monitoring
Some health care organizations that initiate a PE approach may find it practical to continue to use the frameworks already in use in their institutions. However, we strongly recommend that improvement teams familiarize themselves with the ISSUES approach and try it out on a few ethics quality gaps. Then, if the organization elects to utilize an approach other than ISSUES, it will be easier to incorporate relevant aspects of ISSUES into their standard approach.
The Concept of an Ethics Quality Gap Regardless of the approach selected, measurably improving ethical practices depends on the ability to identify, describe, and quantify the “ethics quality gap.” Without a clear understanding of this gap, a well-meaning team may inadvertently weaken rather than strengthen ethical practices. The concept of an ethics quality gap builds on the concept of ethics quality in health care. In the IE model, “ethics quality” is defined as follows: Practices throughout an organization that are consistent with widely accepted ethical standards, norms, or expectations for the organiza-
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tion and its staff. Ethics quality encompasses individual and organizational practices at the level of decisions and actions, systems and processes, and environment and culture.18(p. 2)
An ethics quality gap is defined as “the disparity between current practices and best practices,”18(p. 7) where “best practices” refers to an ideal established on the basis of widely accepted standards, norms, or expectations for the organization and its staff. In other words, the ethics quality gap is the difference between what is (right now) vs. what ought to be (ideally speaking). To fully describe the ethics quality gap, the PE team must be able to perform the following steps: ■ Identify an appropriate ethical standard that applies to the specific ethics issue. ■ Describe the ethical standard, including any exceptions to the standard. ■ Draft an operational definition of best ethics practice on the basis of the ethical standard and the specific ethics issue. ■ Quantify current ethics practice as a baseline against which to compare the impact of subsequent improvement efforts. Consider this example of a hospital’s determination of the gap between best and current practice: Hospital policy requires staff to offer patients information about advance directives during the admission process. Excepted from this policy are patients who are admitted on an emergency basis and those who lack decision making capacity. Based on this standard, the best practice could be described as follows: All patients should be given information about advance directives (AD) during the admission process except for patients who are admitted on an emergency basis or who lack decision making capacity. The current practice was determined based on a chart review of the past 50 admissions: Only 60% of the patients who were supposed to be given information about ADs were actually given this information.
Thus, in this example the ethics quality gap is the difference between the current practice (60% of patients were given the information) and the best practice derived from the ethics standard (all patients should be given the information. Appendix 1 (available in online article) further illustrates these concepts by describing eight additional examples of ethics quality gaps that span multiple domains. After the ethics quality gap is described, it is a simple matter to describe a measureable and achievable improvement goal based on the gap. For example, in the above example, the improvement goal might be stated as follows: The goal is to increase the percentage of inpatients who are offered information about advance directives during the admission process from 60% to 90% by the fourth quarter of 2011.
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The Joint Commission Journal on Quality and Patient Safety Establishing an Ethical Standard One of the most challenging aspects of describing an ethics quality gap is to establish an appropriate ethical standard on which to base the operational definition of best ethics practice. Common sources of ethical standards include institutional policies, executive directives and other senior management guidance, consensus statements or white papers from professional societies, professional codes of ethics, accreditation standards, statutes, and precedents from case law. None of these standards should be adopted uncritically, since ethics thinking often evolves over time and policies or other authoritative sources of ethical standards may not be updated frequently enough to keep pace. In some cases, the PE team may be unable to identify a widely accepted ethical standard on which to base a description of best practice. When this occurs, the novice PE team may be tempted to take on the task of developing a de novo standard. This is not generally advisable for several reasons. First, establishment of a new ethical standard often requires sophisticated ethical analysis, which may be best accomplished by an ethics consultation service. Second, for complex or controversial ethics issues, standard development is best accomplished through a rigorous and inclusive deliberative process. PE teams are not generally set up or staffed to oversee such a process. Third, since most health care organizations have more ethics quality gaps than their PE teams have the capacity to handle, it is often a better use of time for PE teams to begin by addressing ethics issues where the ethical standard is already established. Therefore, when PE teams are faced with an issue for which they are unable to identify a widely accepted ethical standard, they should generally refer the issue to a decision-making body within their institution that has the authority to determine what the standard should be for the institution, and whether a written articulation of the standard (e.g., in a formal policy or executive directive) is warranted. Consider the following example: The chief medical officer asked the PE team to take a look at an ethics issue in the emergency department involving residents and medical students practicing intubation on newly deceased patients. Newly deceased patients were thought to provide a training advantage over mannequins. In a small number of deaths, the next of kin was asked whether they would provide consent for students to practice the procedure, but most of the time, consent was not obtained. The PE team could find no institutional standards that applied to this issue, and a review of available literature showed that not all medical associations agreed that consent from the next of kin was required. The team also contacted the ethics consultation service and found out that this ethical concern had never been referred for ethics analysis. Next, it called the local university hospital and some of its affiliates and found that practices varied, even within the same in-
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stitution. The PE team called the chief medical officer and explained that a clear, institutional practice standard was required before an improvement process could be initiated.
An exception to this example is that in some cases, even though a particular ethical practice is not formally documented in a written standard, the ethical norms that apply to the practice are straightforward and widely accepted. In these instances, the PE team, in consultation with stakeholders (that is, those that stand to be affected by any decision or action) may draft its own “ethical standard” describing the widely accepted norm and proceed with process improvement on that basis. Consider the following example: Nursing staff members on the medical unit have reported that they have been unable to persuade many of the unit’s patient care teams to continue daily rounds on patients who have decided to forgo further curative care and are waiting to be discharged to another care setting for comfort care only. These patients often anxiously ask when they will see their team next, and some patients have revealed that they feel abandoned by their care team now that they are dying. The PE team meets with unit leadership and all agree that the common sense ethical standard is that patient care teams should continue daily rounds on dying patients who have decided to forgo further curative care.
When writing an ethical standard based on a widely accepted norm, PE teams should conduct a routine quality check with those in the institution who have ethics expertise in order to validate that the ethical standard coheres with internal norms developed by the organization, or external norms that apply to the organization. A quality check can also help PE teams avoid a possible trap of thinking that “because everyone is doing it, it is right.”After a standard is established, a best ethics practice can be described, along with an ethics quality gap, which forms the basis for an improvement cycle. ISSUES then proceeds in a stepwise fashion and, similar to other QI approaches, includes flow diagramming, cause and effect analysis, selection of an improvement strategy, and small-scale testing. Appendix 2 (available in online article) summarizes a few of the more than 500 ISSUES cycles that are contained in the VA’s IE library of real-life storyboards.
Practical Steps to Developing a Preventive Ethics Function ACCOUNTABILITY WITHIN THE ORGANIZATIONAL STRUCTURE PE should have a clearly delineated “home” within the organization’s formal structure. Careful placement avoids reproducing a common problem with traditional ethics programs, which have
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The Joint Commission Journal on Quality and Patient Safety frequently operated as silos, without benefit of oversight, accountability, leadership support and access to needed resources.2 The result of this relative isolation within an institution is that ethics programs have sometimes been “invisible,” inexpert, and ineffective. Within the VA’s IE model, PE is situated as a subcommittee of the IE council. The IE council is chaired by the facility director (equivalent to a hospital chief executive officer) and oversees all aspects of the organization’s ethics program, including ethical leadership, ethics consultation, and PE. This involvement by senior management ensures that leadership is engaged. PE depends on leadership support to realize its goals because change processes often require a resource commitment (for example, release of time for the PE team, budget to implement the change strategy) and the participation and cooperation of numerous staff cutting across service lines or departments—which leaders can influence. Given that resource constraints limit the number of ethics improvement projects that can be undertaken, leaders can help prioritize possible ethics issues and make sure that PE activities are aligned with the organization’s strategic plan. Placement within the organization’s ethics program is not the only option. In fact it only works if the organization’s ethics program is itself well integrated with other organizational structures, as it is in the IE model. Alternatively, and depending on local realities, resources, and history, a health care organization may decide to position PE within a strong and versatile quality management program. Given that many of the proficiencies required for PE are found among quality management staff, this option has many potential advantages provided the quality management program is committed to addressing ethics quality gaps, has access to leadership, and establishes clear linkages with the organization’s ethics program, thus securing access to ethics expertise.
THE PE TEAM: SCOPE OF RESPONSIBILITY Within the VA, as part of the IE program, each VA medical center is required by national policy to have a PE team led and managed by a PE coordinator.2 The PE team is responsible for the following: ■ Identifying ethics issues amenable to a QI approach and prioritizing among them ■ Addressing ethics quality gaps across health care ethics domains using ISSUES or a similar QI approach ■ Collaborating across facilities within regional networks to address cross-cutting ethics issues ■ Serving as a resource to their organization’s IE program to support improvement activities based on the annual IntegratedEthics Staff Survey and other commonly available data bases
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and reports ■ Building strong linkages with other QI professionals, bringing an ethics presence to these relationships PE teams in the VA are expected to complete a minimum of two PE improvement cycles annually, although mature teams often do any more.
PE TEAM COMPOSITION Within the VA, PE core teams are typically small, but team size may vary, depending on the organization’s size, level of complexity, and the number and range of ethics issues prioritized by the team and institutional leadership. The aim is to train and develop a core of committed individuals who can facilitate multiple ethics improvement projects concurrently. Because the PE team may be called upon to address ethics issues across the full range of health care ethics domains, the core PE team should not be entirely composed of clinical staff but should include, for example, members from other organizational functions such as finance, accounting, human resources, or information systems management. In addition to the core team, ad hoc members should be added as needed on a time-limited, project-by-project basis. As with other QI programs, ad hoc members are typically selected because they are process owners or bring to the team needed content or process expertise.
PROFICIENCIES REQUIRED TO PERFORM PE Experience has shown that for PE teams to succeed, they need team members who have proficiency in the following areas: ■ QI principles and practices ■ Basic statistical literacy (that is, ability to find, collect, interpret and display data) ■ Ethics expertise, including knowledge of internal and external ethical standards and common ethics topics and concepts ■ Broad knowledge of the health care system ■ Practical knowledge of the local organization, including how to get things done in that environment ■ Project management skills ■ Familiarity with change strategies beyond policy development and education ■ Ability to communicate comfortably and effectively with the organization’s leadership Within the VA, quality managers, patient safety personnel, and systems redesign coordinators have been recruited for PE leadership roles. These staff members tend to possess most of the requisite skill set—often, however, with the important exception of ethics expertise and knowledge of common ethics topics and concepts—and can also promote collaborative relationships with
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The Joint Commission Journal on Quality and Patient Safety other VA programs that focus on improving quality. Obviously, not everyone on the core team will possess all of the proficiencies identified above, but it is critical that the team as a whole have this skill set represented or, at a minimum, have easy access to and support from persons who do. Access to ethics expertise, if not otherwise present on the PE team, can be obtained by formalizing a linkage between the team and the person or group that provides ethics expertise to the institution—typically the ethics consultation service. Many PE teams within the VA include a member of the ethics consultation service as a core PE team member, and in some cases, an individual with ethics expertise is a co-leader of the team.
Getting Started: Identifying Ethics Issues Amenable to a PE Approach Within the VA, primary sources for identifying ethics issues include the IE council, the ethics consultation service, clinical service heads, quality and risk management programs, human resources personnel, compliance and business integrity officers, privacy officers, and patient advocates. The PE team should plan on communicating routinely with these key informants and educating them about the scope and purpose of the program. PE teams within the VA also identify ethics issues through assessment tools such as the IntegratedEthics Staff Survey, and through commonly available VA databases such as the patient advocacy office’s Patient Concerns Tracking System.19 Accreditation reviews can also be useful for identifying ethics issues. New PE teams should also plan on contacting key committees and polling staff regarding perceptions of ethics issues in the organization and within individual work units. As a starting place, PE teams can elicit ethics issues by using open-ended questions such as, “What types of ethics issues do you encounter in your setting?”; “How often does this [ethics issue] happen?”; “Do you have baseline data about the ethics issue?”; “Do you think there are things we could do to prevent the ethics issue from recurring – or at least improve the situation?”; or “What would you suggest to improve the situation?” Although there are virtually unlimited sources of potential ethics issues within an institution, the ethics consultation service should be one of the first stops for identifying ethics issues amenable to a QI approach. An active ethics consultation service is likely to know the ethical challenges commonly faced by patients and staff. We recommend that the PE coordinator meet routinely with the ethics consultation service to discuss recent consultation activities. Within the VA, all ethics consultations are documented in ECWeb, a Web-based electronic tracking tool.2 This tool categorizes all completed ethics consultations by 110
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health care ethics domain (for example, shared decision making) and topic (for example, advance care planning), and thus fosters the efficient identification of high volume, problem-prone processes that are associated with ethics quality gaps. In addition, VA ethics consultants are trained to assess each consultation to decide if there is an underlying systems-level cause and to review these causes with their counterparts on the PE team.
Improving Ethics Quality: Real-life Results Implementation of the IE model across the VA health care system was launched in 2007. The requirement to establish PE teams was codified in national policy in 2009. PE teams document their completed ISSUES cycles on a standardized storyboard template.20 (At the end of each fiscal year, PE teams upload key information from their storyboards to a document- and information-sharing online site, including a title, a “nutshell” of the ethics issue, a statement of the improvement goal, a list of strategies to address the gap, a description of the results, and a point of contact for the storyboard. This Web-based library of PE storyboard information is made available to PE teams across the United States—and the entire VA IE community—which promotes rapid sharing of organizational knowledge and lessons learned. To help PE teams to locate storyboards they are most interested in, the library entries are sortable by year, region, institution, and ethics domain and topic. If a PE team wishes to have more detail about a particular PE project, they can simply open the attached PE storyboard or contact the POC directly. PE teams have been uploading completed storyboards since 2009. At present, the PE Storyboard library consists of 804 storyboards. Storyboards most commonly address ethical issues within the domain of shared decision making (26% of storyboards), followed by resource allocation (18%), professionalism in patient care (11%), end-of-life care (11%), business and management (10%), everyday workplace (10%), privacy and confidentiality (5%), and government service (3%). In addition to the expectation that each facility complete at least two PE projects per year, each of the VA’s 22 regional networks is expected to complete a project pertaining to a crosscutting ethics issue—that is, an ethics quality gap that affects more than one functional unit within the organization. Typically, these projects ensure that processes that support ethical practices are standardized across the region. For example, to address the cross-cutting issue of patients who are discharged against medical advice, a recent project developed a common networkwide approach to ethical practices involving such patients. Summary reports of these activities are also uploaded to the document- and information-sharing online site for use by
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Summary PE in health care has been recognized for almost two decades but has remained underdeveloped on both a conceptual or practical level. VA’s IE model establishes a robust conceptual framework, along with concrete tools and resources, to integrate PE concepts into the day-to-day operations of a health care organization. The PE component of the IE model, which is now in use throughout the VA’s 153 medical centers, is directly transferrable to other health care organizations and systems. J The views expressed herein do not necessarily represent the views of the Department of Veterans Affairs (VA) or the US government. The authors gratefully acknowledge the following Preventive Ethics team members (all VA employees) and their respective facilities for contributing storyboard examples: New York Harbor Health Care System (New York City): David S. Goldfarb, MD; Sathya Maheswaran, MD; Margaret McGibbon, LCSW; Jeannette Alvarez, LCSW; West Texas VA Health Care System (Big Spring, Texas): Janet Daylong, CPC; Bobby Cordova; Shirleen Brown, RN; Elizabeth Moos, RN; Jamie Park, EdD; Arthur Palomino, LCDC; Tonya PriestWieck; Illiana Health Care System (Danville, Illinois): Gwenda Broeren, JD, RN, NEBC; Kevin Krout; Christina Melikyan, MSW; Ramona Charles, MSN, RN, NEA-BC.
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See the online version of this article for
Appendix 1. Examples of Ethics Quality Gaps by Health Care Ethics Domain Appendix 2. Examples of Completed VA Facility Preventive Ethics ISSUES Cycles
Mary Beth Foglia RN, PhD, MA, is IntegratedEthics Manager for Preventive Ethics, National Center for Ethics in Health Care, Veterans Health Administration, United States Department of Veterans Affairs, Washington, DC; and Affiliate Faculty, Department of Bioethics and Humanities, School of Medicine, and Department of Health Services, School of Public Health and Community Medicine, University of Washington, Seattle. Ellen Fox, MD, is Chief Ethics in Health Care Officer, National Center for Ethics in Health Care; Barbara Chanko RN, MBA, is Health Care Ethicist; and Melissa M Bottrell, PhD, MPH, is Chief, IntegratedEthics. Please address correspondence and requests for reprints to
[email protected].
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References 1. U.S. Department of Veterans Affairs, National Center for Ethics in Health Care. Preventive Ethics. Accessed Jan 17, 2012. http://www.ethics.va.gov/ integratedethics/pec.asp. 2. Fox E., et al. IntegratedEthics: An Innovative Program to Improve Ethics Quality in Health Care. Accessed Jan 17, 2012. Innovation J 15(2), article 8, 2010. http://www.innovation.cc/scholarly-style/fox_integrated8ethics_8_final .pdf. 3. Ash Center for Democratic Governance and Innovation at the John F. Kennedy School of Government, Harvard University. Top 25 Innovations in Government Announced. Accessed Jan 17, 2012. http://www.ash.harvard.edu/ Home/News-Events/Press-Releases2/Top-25-Innovations-in-Government -Announced. 4. Foglia MB, Pearlman RA. Clinical and organizational ethics: A systems perspective can provide an antidote to the “silo” problem in clinical ethics consultations. Health Prog. 2006;87(2):31–35. 5. Forrow L, et al. Preventive ethics: Expanding the horizons of clinical ethics. J Clin Ethics. 1993; 4(4):287-294. 6. Asch SE. Opinions and social pressure. Scientific American. 1955; 93(5): 331–335. 7. Asch SE. Studies of independence and conformity: A minority of one against a unanimous majority. Psychological Monographs. 1956;70(No. 416). 8. Colquitt JA, et al. Justice at the millennium: A meta-analytic review of 25 years of organizational justice research. J Appl Psychol. 1991; 86:425–445. 9. Greenberg J, Cropanzano R, editors. Advances in Organizational Justice. Stanford, CA: Stanford University Press, 2000. 10. Smith HR, Caroll AB. Organizational ethics: A stacked deck. Journal of Business Ethics. 1984;3(2):95–100. 11. Worthley J. The Ethics of the Ordinary in Healthcare: Concepts and Cases. Chicago: Health Administration Press, 1997. 12. Leape LL. Errors in medicine. JAMA. 1994 Dec 21;272(23):1851–1857. 13. Reason J, et al. Diagnosing “vulnerable system syndrome:” An essential prerequisite to effective risk management. Qual Health Care. 2001;10 Suppl 2:ii21–ii25. 14. Reason J. Safety in the operating theater Part 2: Human error and organizational failure. Qual Saf Health Care. 2002; 14(1):56–60. 15. Reason J. Beyond the organizational accident: The need for error wisdom on the front line. Qual Saf Health Care. 2004; 13 Suppl 2:ii28–ii33. 16. Reason J. Combating omission errors through task analysis and good reminders. Qual Saf Health Care. 2002; 11(1):40–44. 17. Reason J. Human error: models and management. BMJ. 2000 Mar 18; 320(7237):768–770. 18. Fox E, et al. Preventive Ethics: Addressing Ethics Quality Gaps on a Systems Level. Veterans Health Administration, National Center for Ethics in Health Care, US Department of Veterans Affairs, 2007. Accessed Jan 18, 2012. http://www.ethics.va.gov/docs/integratedethics/Preventive_Ethics_Addressing _Ethics_Quality_Gaps_on_a_Systems_Level_20070808.pdf 19. [AU: REF FOR?] Patient Concerns Tracking System 20. US Department of Veterans Affairs, National Center for Ethics in Health Care. Preventive Ethics ISSUES Storyboard. Accessed Jan 17, 2012. http://www.ethics.va.gov/docs/integratedethics/Preventive_Ethics_ISSUES _Storyboard-Template-20070228.pdf.
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Appendix 1. Examples of Ethics Quality Gaps by Health Care Ethics Domain Ethics Domain: Shared Decision Making with Patients Ethics Issue A recent audit of outpatient health records found that only 10% of outpatient requests for assistance with completing advance directives are followed up on by clinic staff.
Source of the Ethical Standard
Description of the Ethical Standard
Best Ethics Practice “Ought”
Current Ethics Practice “Is”
Facility policy 1004.2 Advance Care Planning and Management of Advance Directives
The facility must provide additional information about advance directives and/or assistance in completing forms for all patients who request this service.
Outpatients who request assistance with completing an advance directive should receive it.
Current ethics practice was determined based on an audit of 100 outpatient health records. Only 10% of outpatients who had a documented request for assistance with completing an advance directive received it.
Ethics Domain: Ethical Practices in End of Life Care Ethics Issue Nursing staff on the medical floor have reported that they are having an increasingly difficult time persuading physicians to round on dying patients waiting to be discharged to another care setting—and that patients continue to ask when the doctor will be in to visit and wonder why the doctor has stopped coming in every day.
Source of the Ethical Standard
Description of the Ethical Standard
Best Ethics Practice “Ought”
Current Ethics Practice “Is”
American Medical Association Statement on End-of-Life Care
Patients should be able to trust that their physician will continue to care for them when dying. If a physician must transfer the patient in order to provide quality care, that physician should make every reasonable effort to continue to visit the patient with regularity, and institutional systems should try to accommodate this.
Physicians should continue to round daily on dying medicine patients that are waiting to be discharged to another care setting.
Current practice was determined by a retrospective health record review of 5 medicine patients per physician awaiting discharge to another care setting. Currently, 3 out of 10 physicians round on dying patients at least once per day while the patient is waiting to be discharged to another care setting. (continued on page AP2)
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Appendix 1. Examples of Ethics Quality Gaps by Health Care Ethics Domain (continued) Ethics Domain: Ethical Practices in End of Life Care Ethics Issue The ICU nurse manager received 4 complaints in the last quarter from families that had been approached for possible organ donation after the patient had expressed a preference against organ donation. He worried that this was just the tip of the iceberg.
Source of the Ethical Standard
Description of the Ethical Standard
Best Ethics Practice “Ought”
Current Ethics Practice “Is”
Facility policy 1101.03 Organ, Tissue and Eye Donation Process
Prior to approaching the family, the facility designated requestor or liaison must review the patient’s health record to determine whether the patient has expressed a preference regarding organ, tissue, and eye donation. If the patient has expressed a preference against donation, the family is not to be approached.
Families of ICU patients should not be approached for possible organ donation when the patient has expressed a preference against donation.
Current practice was determined by reviewing the health records of ICU patients whose family members had been approached for organ donation in the last 6 months. In 7 of 100 cases, the family was approached for possible organ donation when the patient had a documented preference against organ donation. Currently, 7% of families are approached for possible organ donation when the patient has a documented preference against donation.
Ethics Domain: Privacy and Confidentiality Ethics Issue The IntegratedEthics Staff Survey found that 40% of nursing home staff perceived that computers are “almost always” left unattended with personal health information visible on the screen.
Source of the Ethical Standard
Description of the Ethical Standard
The Joint Commission IM.02.01.01
Facilities must have in place administrative, physical, and technical safeguards that will protect electronic health information.
Best Ethics Practice “Ought”
Current Ethics Practice “Is”
Current practice was Computers in the nursing determined through home should not be left observation across all unattended with a patient’s three shifts over a 2-day personal health information visible on the period. Observations were recorded and tallied on a screen. checklist. Currently, in 40% of observations, computers were observed to be unattended with a patient’s personal health information visible on the screen. (continued on page AP3)
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Appendix 1. Examples of Ethics Quality Gaps by Health Care Ethics Domain (continued) Ethics Domain: Professionalism in Patient Care Ethics Issue The quality manager for surgical services found a number of instances where adverse events that should have been disclosed to patients or surrogate decision makers were not disclosed.
Source of the Ethical Standard
Description of the Ethical Standard
Facility policy 2008-002: Disclosure of Adverse Events to Patients
Best Ethics Practice “Ought”
Patients or the surrogate Adverse events that cause decision maker must be harm to patients on informed of the occurrence surgical services should of any adverse event that be disclosed to the has resulted in harm to patient or surrogate the patient. decision maker.
Current Ethics Practice “Is” Current practice was determined by identifying all adverse events that caused harm to patients on surgical services over the past six months through a review of incident reports. The health records of these patients were reviewed for a disclosure note. Currently, 65% of adverse events that cause harm to patients on surgical services are being disclosed to the patient or surrogate decision maker.
Ethics Domain: Ethical Practices in the Everyday Workplace Ethics Issue The ethics consultation service’s annual report for FY 2010 found that none of their consultations were about ethical concerns affecting nonclinical staff.
Source of the Ethical Standard
Description of the Ethical Standard
Best Ethics Practice “Ought”
Current Ethics Practice “Is”
IntegratedEthics Program Requirements
Just as IE addresses all three levels of ethics quality, it also deals with the full range of ethics concerns that commonly arise in health care—not just clinical concerns.
Ethics consultation services should address ethical concerns affecting nonclinical staff.
Current practice was determined by a review of the ethics consultation service’s annual report for FY2010. Currently, no ethics consultations are about ethical concerns affecting nonclinical staff. (continued on page AP4)
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Appendix 1. Examples of Ethics Quality Gaps by Health Care Ethics Domain (continued) Ethics Domain: Ethical Practices in Business and Management Ethics Issue Coding staff are not routinely consulting physicians to clarify conflicting or ambiguous documentation in the patient’s electronic health record, and therefore enter inaccurate information.
Source of the Ethical Standard
Description of the Ethical Standard
Best Ethics Practice “Ought”
Current Ethics Practice “Is”
American Health Information Management Association Code of Ethics
Health information management professionals shall not participate in, condone, or be associated with dishonesty, fraud and abuse, or deception including: ■ Assigning codes without physician documentation ■ Coding when documentation does not justify the procedures that have been billed ■ Coding an inappropriate level of service ■ Miscoding to avoid conflict with others
Coding staff should ensure accurate coding by reviewing conflicting or ambiguous documentation with the physician of record
Current practice was determined by asking coding staff to retrospectively identify records in the past 10 days where physician input may have been warranted.
Description of the Ethical Standard
Best Ethics Practice “Ought”
Currently, 12% of total records reviewed represent cases where physician input may have been warranted to clarify conflicting or ambiguous health record documentation.
Ethics Domain: Ethical Practices in Research Ethics Issue Parents of children with serious life threatening diagnoses participating in a research study at a regional medical center claimed that they were not adequately informed about costs (e.g., gas, food, and lodging) associated with study participation.
Source of the Ethical Standard Title 45 CFR Part 46 Protection of Human Subjects Subpart 46.116 General Requirements for Informed Consent
Additional elements of Costs that may result from informed consent: When research participation appropriate, one or more should be disclosed to of the following elements potential research subjects of information shall also be during the informed provided to each subject. consent conference. (3) Any additional costs to the subject that may result from participation in the research.
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Current Ethics Practice “Is” Current practice was determined by observing 10 informed consent conferences for the research study. Currently, the expected costs of research participation are disclosed only 10% of the time.
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Appendix 2. Examples of Completed VA Facility Preventive Ethics ISSUES Cycles* Ethics Domain
Ethics Issue
Goal
Process Changes
Measures
Result
Shared Decision Making
A chart audit revealed that the advance directives of chronic dialysis patients were not accurately completed (for example, missing information)— making it unclear whether the documents were valid and accurately reflected patient preferences about future care if they lost decision making capacity.
Increase the % of advance directives of dialysis patients that are accurately completed from 58% to 90 % by quarter/year.
Revised job description of dialysis social worker to coordinate advance care planning process
% of accurately completed advance directives
Increased accuracy of completed advance directives from 58% to 96% by quarter/year.
% of DNR orders signed by the attending physicians within 24 hours of admission
Increased the % of DNR orders signed by the attending physicians within 24 hours of admission from 40% to over 90% by quarter/year.
Simplified the process (for example, removed steps) and clarified roles within the process Instituted a quality checklist to ensure that only valid advance directives are scanned into the patient medical record Initiated routine patient education regarding advance directives
Ethical Practices in End-of-Life Care
Developed a code status There have been long Increase the % of template for the electronic standing complaints from DNR orders medical record with auto inpatient nursing staff that signed by the alert to the attending Do-not-resuscitate (DNR) attending physiphysician. orders written by medical cian within 24 residents are not reviewed hours of admission and signed off on by the at- from 40% to 90% Developed distinct note titles tending physician within 24 by quarter/year. and directions on how to use the templates when writing hours of the patient’s adcode status orders. mission—thus allowing the DNR order to expire. Provided ongoing education to residents and attending Nursing staff noted that if a physicians on the rationale code was called on a and use of the template. patient whose DNR order expired, staff could Updated facility policy. inadvertently attempt to resuscitate a patient who did not wish to be resuscitated.
(continued on page AP6)
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Appendix 2. Examples of Completed VA Facility Preventive Ethics ISSUES Cycles* (continued) Measures
Result
Patient Privacy and Confidentiality
Food service workers noted Decrease the % of Produced new labels that that private patient food items that exclude unnecessary patient information (that is, full are labeled with identifiers name, date of birth, and private patient complete social security information from Produced and placed number) was included on 100% to 0% by reminder magnets on unit all patient food items stored quarter/year. refrigerator alerting staff to in a community refrigerator check items placed in the accessed by patients, refrigerators for visitors, and staff. inappropriate identifiers
% of labels that included private patient information
Decreased % of labels that included private patient information from 100% to 0% by quarter/year.
Professionalism in Patient Care
A chart review found that Increase the % of patients discharged from AMA patients that the institution against are discharged medical advice (AMA) were with follow up frequently discharged appointments without prescriptions or and required follow up clinic medications from appointments, and 25% to 90% by previously scheduled quarter/year. appointments were automatically cancelled.
Created CMO and CNO directive to clinicians to ensure that AMA patients receive required medications and follow up appointments
% of AMA patients discharged with follow up appointments and required medications
Increased the % of AMA patients discharged with follow up appointments and required medications from 25% to 100% by quarter/year.
An informal punitive culture towards AMA patients among attending and resident physicians reinforced and sustained this practice despite patient and staff complaints.
Discharge procedures revised to delineate ethically appropriate discharge practices for patients that leave AMA
Ethics Domain
Ethics Issue
Goal
Process Changes
Notified scheduling office that future appointments for AMA patients should no longer be automatically cancelled
Note: Denominator changed to exclude patients that did not wish to have follow up care scheduled or that left the institution without notifying staff. These practices were adopted by this facility’s entire regional network. (continued on page AP7)
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Appendix 2. Examples of Completed VA Facility Preventive Ethics ISSUES Cycles* (continued) Ethics Domain Ethical Practices in the Everyday Workplace
Ethics Issue
Goal
The IntegratedEthics Staff Increase the Survey suggested that staff number of ethical members were reluctant to concerns referred raise ethical concerns that to the consultation arose in their work setting. service from 4 to Further efforts to under10 by quarter/year. stand the survey results found that most staff did not know how to locate or use the web based tool for referring ethical concerns to the consultation service. The result was that many of the staffs’ ethical concerns were neither reported or addressed—undermining the facility’s commitment to development of an ethical health care environment.
Process Changes
Measures
Result
Relocated Web-based tool link to facility’s home page to make it easier to locate.
Number of ethical concerns referred to the consultation service
Increased the number of ethical concerns referred to the consultation service from 4 to 48 for an increase of 1200% by quarter/year.
Trained and certified service chiefs in the use of the Web-based tool for referring ethical concerns to the consultation service. Developed an electronic guide including screenshots on the consultation referral process for use by service chiefs and staff. Service chiefs, supported by the PE team, provided training to staff in use of the Web-based tool. Clarified that the role of the service chief is to encourage staff to bring ethical concerns forward through acting as an on-going resource in the use of the Web-based tool.
* VA, US Department of Veterans Affairs.
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