Safety in mental health

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* The Institute of Medicine defines quality as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Source:Source: Committee to Design a Strategy for Quality Review and Assurance in Medicare, Institute of Medicine. Medicare: A Strategy for Quality Assurance, vol. 1. Lohr KN, ed. Washington, DC: The National Academies Press, 1990.

Introduction The quality of care and the safety of individuals served are core values of The Joint Commission accreditation process. This is a commitment The Joint Commission has made to individuals served, patients, and families, as well as behavioral health care practitioners, staff, and organization leaders. This chapter exemplifies that commitment.

The intent of this “Safety Systems for Individuals Served” (SSIS) chapter is to provide behavioral health care organizations with a proactive approach to designing or redesigning services that aim to improve the quality of care and safety for the individual, an approach that aligns with the Joint Commission’s mission and its standards.

The Joint Commission partners with accredited behavioral health care organizations to improve behavioral health care delivery to protect individuals. Therefore, this chapter is focused on the following two guiding principles: 1. Assisting behavioral health care organizations with advancing knowledge, skills, and

competence of staff and individuals served by recommending methods that will improve quality and safety processes.

2. Encouraging and recommending proactive quality and safety methods for the individuals served that will increase accountability, trust, and knowledge while reducing the impact of fear and blame.

Quality* and safety are inextricably linked. Quality behavioral health care is the degree to which its processes and results meet or exceed the needs and desires of the individuals it serves.1,2 Those needs and desires include safety.

To ensure quality and safety in the behavioral health care setting, components of the management system should include the following:

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Ensuring reliable processes Decreasing variation and defects (waste) Focusing on achieving better outcomes Using evidence to ensure that a service is satisfactory

Safety of the individual emerges as a central aim of quality. Safety is what individuals served, patients, families, staff, and the public expect from Joint Commission–accredited organizations. While safety events may not be completely eliminated, harm to individuals can be reduced, and the goal is always zero harm. This chapter describes and provides approaches and methods that may be adapted by a behavioral health care organization that aims to increase the reliability of its complex systems while making visible and removing the risk of harm to the individual. Joint Commission–accredited organizations should be continually focused on eliminating system and process failures and human errors that may cause harm to individuals served, patients, families, and staff.1,2

The ultimate purpose of The Joint Commission’s accreditation process is to enhance quality of care and safety for individuals served. Each requirement or standard, the survey process, the Sentinel Event Policy, and other Joint Commission initiatives are designed to help organizations reduce variation, reduce risk, and improve quality. Behavioral health care organizations should have an integrated approach to safety so that high levels of safe care can be provided for every individual in every care setting and service.

Behavioral health care organizations are complex environments that depend on strong leadership to support an integrated safety system that includes the following:

Safety culture Validated methods to improve processes and systems Standardized ways to communicate and collaborate within their agency or outside of the organization Safely integrated technologies

In an integrated safety system, staff and leaders work together to eliminate complacency, promote collective mindfulness, treat each other with respect and compassion, and learn from their safety events, including close calls and other system failures that have not yet led to the harm of an individual.

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† The term “safety event” has been adapted for use in this chapter.

What Does This Chapter Contain? “Safety Systems for Individuals Served” (SSIS) chapter is intended to help inform and educate behavioral health care organizations about the importance and structure of an integrated safety system for the individuals they serve. ThisThis chapterchapter describesdescribes howhow existingexisting requirementsrequirements cancan bebe appliedapplied toto achieveachieve improvedimproved patientpatient safety;safety; itit doesdoes notnot containcontain anyany newnew requirements.requirements. It is also intended to help all behavioral health care providers understand the relationship between Joint Commission accreditation and the safety of the individual.

This chapter does the following: Describes an integrated safety system that focuses on the individual Discusses how behavioral health care organizations can develop into learning organizations Explains how organizations can continually evaluate the status and progress of their safety systems Describes how organizations can work to prevent or respond to safety events (Sidebar 1 defines key terminology) Serves as a framework to guide organization leaders as they work to improve safety for individuals in all behavioral health care settings Contains a list of standards and requirements related to safety systems (which will be scored as usual in their original chapters) Contains references that were used in the development of this chapter

This chapter refers to a number of Joint Commission standards. Standards cited in this chapter are formatted with the standard number in boldface type (for example, “Standard RI.01.01.01RI.01.01.01”) and are accompanied by language that summarizes the standard. For the full text of a standard and its element(s) of performance (EP), please see the Appendix.

Sidebar 1. Key Terms to Understand

Safety event:† An event, incident, or condition that could have resulted or did result in harm to an individual served or a patient. Adverse event: A safety event that resulted in harm to an individual served.

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‡ For a list of specific safety events that are also considered sentinel events, see page SE-1 in the “Sentinel Events” (SE) chapter of this manual.

Sentinel event:‡ A subcategory of Adverse Events, a Sentinel Event is a safety event (not primarily related to the natural course of an illness or underlying condition of the individual served) that reaches an individual and results in any of the following:

Death Permanent harm Severe temporary harm

No-harm event: A safety event that reaches the individual served but does not cause harm. Close call (or “near miss,” or “good catch”: A safety event that did not did not reach the individual served. Hazardous (or “unsafe”) condition(s): A circumstance (other than an individual’s own disease process or condition) that increases the probability of an adverse event.

Note: It is impossible to determine if there are practical prevention or mitigation countermeasures available without first doing an event analysis. An event analysis will identify systems-level vulnerabilities and weaknesses and the possible remedial or corrective actions that can be implemented.

Becoming a Learning Organization The need for sustainable improvement in the safety and quality of care an individual receives has never been greater. One of the fundamental steps to achieving and sustaining this improvement is to become a learning organization. A learning organization is one in which people learn continuously, thereby enhancing their capabilities to create and innovate.3 Learning organizations uphold five principles: team learning, shared visions and goals, a shared mental model (that is, similar ways of thinking), individual commitment to lifelong learning, and systems thinking.3 In a learning organization, safety events are seen as opportunities for learning and improvement.4 Therefore, leaders in learning organizations adopt a transparent, nonpunitive approach to reporting so that the organization can report to learn and can collectively learn from safety events. In order to become a learning organization, a behavioral health care organization must have a fair and just safety culture, a strong reporting system, and a commitment to put that data to work by driving improvement. Each of these require the support and encouragement of a behavioral health care organization’s executive leaders.

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Leaders, staff, behavioral health care providers, and individuals served in a learning organization realize that every safety event (from close calls to events that cause major harm to individuals) must be reported.4-8 When events that have caused or could have caused harm are continuously reported, experts within the behavioral health care organization can define the problem, identify solutions, achieve sustainable results, and disseminate the changes or lessons learned to the rest of the organization.4-8 In a learning organization, the behavioral health care organization provides staff with information regarding improvements based on reported concerns. This helps foster trust that encourages further reporting.

The Role of Behavioral Health Care Leaders in Safety (of the Individual Served) Behavioral health care leaders provide the foundation for an effective safety system for the individual served by doing the following:9

Promoting learning Motivating staff to uphold a fair and just safety culture Providing a transparent environment in which quality measures and harm to individuals are freely shared with staff Modeling professional behavior Removing intimidating behavior that might prevent safe behaviors Providing the resources and training necessary to take on improvement initiatives

For these reasons, many of the standards that are focused on the behavioral health care organization’s safety system appear in the Joint Commission’s Leadership (LD) standards, including Standard LD.04.04.05LD.04.04.05 (which focuses on having an organization- wide, integrated safety program within performance improvement activities).

Without the support of behavioral health care leaders, organizationwide changes and improvement initiatives are difficult to achieve. Leadership engagement in safety and quality initiatives for individuals is imperative because 75% to 80% of all initiatives that require people to change their behaviors fail in the absence of leadership managing the change.4 Thus, leadership should take on a long-term commitment to transform their organization.10

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Safety Culture A strong safety culture is an essential component of a successful safety system and is a crucial starting point for behavioral health care organizations striving to become learning organizations. In a strong safety culture, the organization has an unrelenting commitment to safety and to do no harm. Among the most critical responsibilities of behavioral health care leaders is to establish and maintain a strong safety culture within their organization. The Joint Commission’s standards address safety culture in Standard LD.03.01.01LD.03.01.01, which requires leaders to create and maintain a culture of safety and quality throughout their behavioral health care organization.

The safety culture of a behavioral health care organization is the product of individually held and group beliefs, values, attitudes, perceptions, competencies, and patterns of behavior that determine the organization’s commitment to quality and safety for individuals. Behavioral health care organizations that have a robust safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures.11

Organizations will have varying levels of safety culture, but all should be working toward a safety culture that has the following qualities:

Staff and leaders that value transparency, accountability, and mutual respect.4

Safety as everyone’s first priority.4

Behaviors that undermine a culture of safety are not acceptable, and thus should be reported to organizational leadership by individuals served, patients, staff, and families for the purpose of fostering risk reduction.4,10,12

Collective mindfulness is present, wherein staff realize that systems always have the potential to fail and staff are focused on finding hazardous conditions or close calls at early stages before an individual may be harmed.10 Staff do not view close calls as evidence that the system prevented an error but rather as evidence that the system needs to be further improved to prevent any defects.10,13

Staff who do not deny or cover up errors but rather want to report errors to learn from mistakes and improve the system flaws that contribute to or enable safety events.6 Staff know that their leaders will focus not on blaming providers involved in errors but on the systems issues that contributed to or enabled the safety event.6,14

By reporting and learning from safety events, staff create a learning organization.

A safety culture operates effectively when the organization fosters a cycle of trust, reporting, and improvement.10,15 In organizations that have a strong safety culture, behavioral health care providers trust their coworkers and leaders to support them when they identify and report a safety event.10 When trust is established, staff are more likely

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to report safety events, and organizations can use these reports to inform their improvement efforts. In the trust-report-improve cycle, leaders foster trust, which enables staff to report, which enables the organization to improve.10 In turn, staff see that their reporting contributes to actual improvement, which bolsters their trust. Thus, the trust-report-improve cycle reinforces itself.10 (See Figure 1.)

FigureFigure 1.1. The Trust-Report-Improve Cycle with Robust Process Improvement® (RPI®)

In the trust-report-improve cycle, trust promotes reporting, which leads to improve- ment, which in turn fosters trust.

Leaders need to ensure that intimidating or unprofessional behaviors within the behavioral health care organization are addressed, so as not to inhibit anyone inside the organization from reporting safety concerns.16 Leaders should both educate staff and hold them accountable for professional behavior. This includes the adoption and promotion of a code of conduct that defines acceptable behavior as well as behaviors that undermine a culture of safety. The Joint Commission’s Standard LD.03.01.01LD.03.01.01, EP 4, requires that leaders develop such a code.

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Intimidating and disrespectful behaviors disrupt the culture of safety and prevent collaboration, communication, and teamwork, which is required for the safe and highly reliable care of individuals served.17 Disrespect is not limited to outbursts of anger that humiliate a member of the behavioral health care team; it can manifest in many forms, including the following:4,12,17

Inappropriate words (profane, insulting, intimidating, demeaning, humiliating, or abusive language) Shaming others for negative outcomes Unjustified negative comments or complaints about another provider’s care Refusal to comply with known and generally accepted practice standards, the refusal of which may prevent other providers from delivering quality care Not working collaboratively or cooperatively with other members of the interdisci- plinary team Creating rigid or inflexible barriers to requests for assistance or cooperation Not returning pages or calls promptly

A Fair and Just Safety Culture A fair and just safety culture is needed for staff to trust that they can report safety events without being treated punitively.2,8 In order to accomplish this, behavioral health care organizations should provide and encourage the use of a standardized reporting process for staff to report safety events. This is also built into the Joint Commission’s standards at Standard LD.04.04.05LD.04.04.05, EP 6, which requires leaders to provide and encourage the use of systems for blame-free reporting of a system or process failure or the results of proactive risk assessments. Reporting enables both proactive and reactive risk reduction. Proactive risk reduction solves problems before individuals served are harmed, and reactive risk reduction attempts to prevent the recurrence of problems that have already caused harm to an individual served.10,15

A fair and just culture takes into account that people are human, fallible, and capable of mistakes, and that they work in systems that are often flawed. In the most basic terms, a fair and just culture holds people accountable for their actions but does not punish them for issues attributed to flawed systems or processes.14,18,19 Refer to Standard LD.04.01.05LD.04.01.05, EP 4, which requires that staff are held accountable for their responsibilities.

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It is important to note that for some actions for which a person is accountable, he or she should be held culpable and some disciplinary action may then be necessary. (See Sidebar 2 for a discussion of tools that can help leaders determine a fair and just response to a safety event.) However, staff should never be punished or ostracized for reportingreporting the event, close call, hazardous condition, or concern.

Sidebar 2. Assessing Staff Accountability

The aim of a safety culture is not a “blame-free” culture but one that balances learning with accountability. To achieve this, it is essential that leaders assess errors and patterns of behavior in a manner that is applied consistently, with the goal of eliminating behaviors that undermine a culture of safety. There has to exist within the behavioral health care organization a clear, equitable, and transparent process for recognizing and separating the blameless errors that fallible humans make daily from the unsafe or reckless acts that are blameworthy.1–10

There are a number of sources for information (some of which are listed immediately below) that provide rationales, tools, and techniques that will assist an organization in creating a formal decision process to determine what events should be considered blameworthy and require individually directed action in addition to systems-level corrective actions. The use of a formal process will reinforce the culture of safety and demonstrate the organization’s commitment to transparency and fairness.

Reaching answers to these questions requires an initial investigation into the safety event to identify contributing factors. The use of the Incident Decision Tree (adapted by the United Kingdom’s National Patient Safety Agency from James Reason’s culpability matrix) or other formal decision process can help make determinations of culpability more transparent and fair.5

References 1. The Joint Commission. Behaviors that undermine a culture of safety. Sentinel

Event Alert, No. 40, Jul 9, 2009. Accessed Sep 3, 2013. http:// www.jointcommission.org/sentinel_event_alert_issue_40_behaviors_ that_undermine_a_culture_of_safety/

2. The Joint Commission. Leadership committed to safety. Sentinel Event Alert. Aug 27, 2009. Accessed Sep 8, 2013. http://www.jointcommission.org/ sentinel_event_alert_issue_43_leadership_committed_to_safety

3. Marx D. How building a ‘just culture’ helps an organization learn from errors. OR Manager. 2003 May;19(5):1, 14–15, 20.

4. Reason J; Hobbs A. Managing Maintenance Error. Farnham, Surrey, United Kingdom: Ashgate Publishing, 2003.

5. Vincent C. Patient Safety, 2nd ed. Hoboken, NJ: Wiley-Blackwell, 2010. 6. National Patient Safety Agency. Incident Decision Tree. Accessed Sep 7, 2013.

http://www.nrls.npsa.nhs.uk/resources/?EntryId45=59900

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7. Bagian JP, et al. Developing and deploying a patient safety program in a large health care delivery system: You can’t fix what you don’t know about. Jt Com J Qual Patient Saf. 2001 Oct;27(10):522–532.

8. National Patient Safety Foundation. RCA2: Improving Root Cause Analyses and Actions to Prevent Harm. Jun 16, 2015. Accessed Jun 23, 2015. http:// www.npsf.org/?page=RCA2

9. The Joint Commission. Webinar Replay and Slides: Building Your Safety Culture: A Job for Leaders. Chassin M. April 27, 2017. Accessed Jul 28, 2017. https://www.jointcommission.org/webi- nar_replay_slides_sea_issue_57_building_your_safety_culture_leaders/

10. The Joint Commission. Take 5: Building a Strong Safety Culture - A Job For Leaders. Benedicto A. May 10, 2017. Accessed Jul 28, 2017. https:// www.jointcommission.org/podcast.aspx

Data Use and Reporting Systems An effective culture of safety is evidenced by a robust reporting system and use of measurement to improve. When health care organizations adopt a transparent, nonpunitive approach to reports of safety events or other concerns, the behavioral health care organization begins reporting to learn—and to learn collectively from adverse events, close calls, and hazardous conditions. This section focuses on data from reported safety events. Behavioral health care organizations should note that this is but one type of data among many that should be collected and used to drive improvement.

When there is continuous reporting for adverse events, close calls, and hazardous conditions, behavioral health care organizations can analyze the safety events, change the process or system to improve safety, and disseminate the changes or lessons learned to the rest of the organization.20–24

In addition to those mentioned earlier in this chapter, a number of standards relate to the reporting of safety information, including Performance Improvement (PI) Standard PI.01.01.01PI.01.01.01, which requires behavioral health care organizations to collect data to monitor their performance, and Standard LD.03.02.01LD.03.02.01, which requires behavioral health care organizations to use data and information to guide decisions and to understand variation in the performance of processes supporting safety and quality.

Behavioral health care organizations can engage frontline staff in internal reporting in a number of ways, including the following:

Create a nonpunitive approach to safety event reporting Educate staff on identifying safety events that should be reported Provide timely feedback regarding actions taken on safety events

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Effective Use of Data Collecting Data When behavioral health care organizations collect data or measure staff compliance with evidence-based care processes or outcomes for individuals served, they can manage and improve those processes or outcomes and, ultimately, improve safety for individuals.25

The effective use of data enables organizations to identify problems, prioritize issues, develop solutions, and track to determine success.9 Objective data can be used to support decisions, influence people to change their behaviors, and to encourage compliance with evidence-based care guidelines.9,26

The Joint Commission requires behavioral health care organizations to collect and use data related to outcomes from care, treatment, or services provided to the individuals served, including any sustained harm. Some key Joint Commission standards related to data collection and use require behavioral health care organizations to do the following:

Collect information to monitor conditions in the environment (Standard EC.04.01.01EC.04.01.01) Identify risks for acquiring and transmitting infections (Standard IC.01.03.01IC.01.03.01) Use data and information to guide decisions and to understand variation in the performance of processes supporting safety and quality (Standard LD.03.02.01LD.03.02.01) Have an organizationwide, integrated safety program within any performance improvement activities (Standard LD.04.04.05LD.04.04.05) Evaluate the effectiveness of the medication management system (Standard MM.08.01.01MM.08.01.01) Report deaths associated with the use of restraint and seclusion (Standard RC.02.01.05RC.02.01.05) Collect data to monitor performance (Standard PI.01.01.01PI.01.01.01) Improve performance on an ongoing basis (Standard PI.03.01.01PI.03.01.01)

Analyzing Data Effective data analysis can enable a behavioral health care organization to better assess problems within its systems or organization similar to how providers assess the condition of an individual served based on behaviors, history, and other factors. Turning data into information is a critical competency of a learning organization and of effective management of change. When the right data are collected and appropriate analytic techniques are applied, it enables the behavioral health care organization to monitor the performance of a system, detect variation, and identify opportunities to improve. This

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can help the behavioral health care organization not only understand the current performance of organizationwide systems but also can help it predict its performance going forward.23

Analyzing data with tools such as run charts, statistical process control (SPC) charts, and capability charts helps a behavioral health care organization determine what has occurred in a system and provides clues as to why the system responded as it did.23 Table 1 describes and compares examples of these tools. Please note that several types of SPC charts exist; this discussion focuses on the XmR chart, which is the most commonly used.

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Table 1. Defining and Comparing Analytical Tools

Tool When to Use Example

Run Chart1  When the behavioral health care organization needs to identify variation within a system

 When the behavioral health care organization needs a simple and straightforward analysis of a system

 As a precursor to an SPC chart

Statistical Process Control Chart

 When the behavioral health care organization needs to identify variation within a system and find indicators of why the vari- ation occurred

 When the behavioral health care organization needs a more detailed and in-depth analysis of a system

Capability Chart2  When the behavioral health care organization needs to determine whether a process will function as expected, ac- cording to requirements or specifications

In the example above, the curve at the top of the chart indicates a process that is only partly capable of meeting requirements. The curve at the bottom of the chart shows a process that is fully capable.

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Sources: 1. Agency forHealthcareResearchandQuality.AdvancedMethods inDeliverySystem

Research—Planning,Executing,Analyzing,andReportingResearchonDeliverySystem Improvement.Webinar#2:StatisticalProcessControl. Jul2013.AccessedAug21,2015.http:// www.ahrq.gov/professionals/prevention-chronic-care/improve/coordination/webinar02/in- dex.html. (Example2,above).

2. GeorgeML,etal.TheLeanSixSigmaPocketToolbook:AQuickReferenceGuide toNearly 100Tools for ImprovingProcessQuality,Speed,andComplexity.NewYork:McGraw-Hill, 2005.Usedwithpermission.

Using Data to Drive Improvement After data has been turned into information, leadership should ensure the following (in accordance with the requirements shown):27–29

Information is presented in a clear manner (Standard LD.03.04.01LD.03.04.01, EP 3) Information is shared with the appropriate groups throughout the organization (from the staff to governance) (Standards LD.03.04.01LD.03.04.01, LD.04.04.05LD.04.04.05) Opportunities for improvement and actions to be taken are clearly articulated (Standards LD.03.05.01LD.03.05.01, EP 4; LD.04.04.01LD.04.04.01) Improvements are celebrated or recognized

A Proactive Approach to Preventing Harm Proactive risk reduction prevents harm before it reaches the individual served. By engaging in proactive risk reduction, a behavioral health care organization can correct process problems in order to reduce the likelihood of experiencing adverse events.

In a proactive risk assessment, the behavioral health care organization evaluates a process to see how it could potentially fail, to understand the consequences of such a failure, and to identify parts of the process that need improvement. A proactive risk assessment increases understanding within the organization about the complexities of process design and management—and what could happen if the process fails.

When conducting a proactive risk assessment, organizations should prioritize high-risk, high-volume areas. Areas of risk are identified from internal sources such as ongoing monitoring of the environment, results of previous proactive risk assessments, from results of data collection activities. Risk assessment tools should be accessed from credible external sources such as a Sentinel Event Alert, nationally recognized risk assessment tools, and peer review literature. Benefits of a proactive approach to the safety of individuals includes increased likelihood of the following:

Identification of actionable common causes Avoidance of unintended consequences

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§ Human errors are typically skills based, decision based, or knowledge based, whereas violations could be either routine or exceptional (intentional or negligent). Routine violations tend to include habitual “bending of the rules,” often enabled by management. A routine violation may break established rules or policies, and yet be a common practice within an organization. An exceptional violation is a willful behavior outside the norm that is not condoned by management, engaged in by others, and not part of the individual’s usual behavior. Source:Source: Diller T, et al. The human factors analysis classification system (HFACS) applied to health care. Am J Med Qual. 2014 May–Jun;29(3)181–190.

Identification of commonalities across departments/services/units Identification of system solutions Sufficient staff Completion of environmental risk assessment Identification of individuals who may be harmful to themselves or others

Hazardous (or unsafe) conditions provide an opportunity for a behavioral health care organization to take a proactive approach to reduce harm. Behavioral health care organizations also benefit from identifying hazardous conditions while designing any new process that could impact the safety of an individual. A hazardous condition is defined as any circumstance that increases the probability of a safety event. A hazardous condition may be the result of a human error or violation, may be a design flaw in a system or process, or may arise in a system or process in changing circumstances.§ A proactive approach to such conditions should include an analysis of the systems and processes in which the hazardous condition is found, with a focus on conditions that preceded the hazardous condition. (See Sidebar 3.)

A proactive approach to hazardous conditions should include an analysis of the related systems and processes, including the following aspects:30

Preconditions.Preconditions. Examples include hazardous (or unsafe) conditions in the environ- ment of care (such as noise, clutter, wet floors and so forth), inadequate staffing levels, an operator of equipment who is impaired or inadequately trained. SupervisorySupervisory influences.influences. Examples include inadequate supervision, failure to address a known problem, authorization of activities that are known to be hazardous. OrganizationalOrganizational influences.influences. Examples include inadequate staffing, inadequate poli- cies, lack of strategic risk assessment.

Behavioral health care organizations should recognize that this standard represents a minimum requirement. Organizations working to become learning organizations are encouraged to exceed this requirement by constantly working to proactively identify risk.

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Sidebar 3. Strategies for an Effective Risk Assessment

Although several methods could be used to conduct a proactive risk assessment, the following steps comprise one approach:

Describe the chosen process (for example, through the use of a flowchart). Identify ways in which the process could break down or fail to perform its desired function, which are often referred to as “failure modes.” Identify the possible effects that a breakdown or failure of the process could have on individuals and the seriousness of the possible effects. Prioritize the potential process breakdowns or failures. Determine why the prioritized breakdowns or failures could occur, which may involve performing a hypothetical root cause analysis. Design or redesign the process and/or underlying systems to minimize the risk of the effects on individuals. Test and implement the newly designed or redesigned process. Monitor the effectiveness of the newly designed or redesigned process.

Tools for Conducting a Proactive Risk Assessment A number of tools are available to help organizations conduct a proactive risk assessment. One of the best known of these tools is the Failure Modes and Effects Analysis (FMEA). An FMEA is used to prospectively examine how failures could occur during high-risk processes and, ultimately, how to prevent them. The FMEA asks “What if?” to explore what could happen if a failure occurs at particular steps in a process.31

Behavioral health care organizations have other tools they can consider using in their proactive risk assessment. Some examples include the following:

Institute for Safe Medication Practices Medication Safety Risk Assessment: This tool is designed to help reduce medication errors (for organizations such as opioid treatment providers). Visit https://www.ismp.org/selfassessments/default.asp for more information. Contingency diagram: The contingency diagram uses brainstorming to generate a list of problems that could arise from a process. Visit https://healthit.ahrq.gov/ health-it-tools-and-resources/evaluation-resources/workflow-assessment-health-it- toolkit/all-workflow-tools/contingency-diagram.

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Potential problem analysis (PPA) is a systematic method for determining what could go wrong in a plan under development. The problem causes are rated according to their likelihood of occurrence and the severity of their consequences. Visit https://healthit.ahrq.gov/health-it-tools-and-resources/evaluation-resources/ workflow-assessment-health-it-toolkit/all-workflow-tools for more information. Process decision program chart (PDPC) provides a systematic means of finding errors with a plan while it is being created. After potential issues are found, preventive measures are developed, allowing the problems to either be avoided or a contingency plan to be in place should the error occur. Visit http://healthit.ahrq .gov/health-it-tools-and-resources/workflow-assessment-health-it-toolkit/all-work- flow-tools/process-decision-program-chart.

Encouraging Participation of Individuals Served To achieve the best outcomes, individuals served and families must be more actively engaged in decisions about their behavioral health care and must have broader access to information and support. Activation of the individual served is inextricably intertwined with the safety of the individual. Activated individuals are less likely to experience harm and unnecessary reassessments. Individuals who are less activated suffer poorer health outcomes and are less likely to follow their provider’s advice.32,33

An approach to care centered on the individual served can help behavioral health care organizations assess and enhance the activation of the individual. Achieving this requires leadership engagement in the effort to establish care centered on the individual as a top priority throughout the behavioral health care organization. This includes adopting the following principles:34

Safety for the individual guides all decision making. Individuals served and families are partners at every level of care. Care centered on the individual and family-centered care is verifiable, rewarded, and celebrated. The behavioral health care provider responsible for the care of the individual served, or his or her designee, discloses to the individual and the family any unanticipated outcomes of care, treatment, or services. Though Joint Commission standards do not require apology, evidence suggests that individuals served benefit—and are less likely to pursue litigation—when behavioral health care providers disclose harm, express sympathy, and apologize.

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Staffing levels are sufficient, and staff has the necessary tools and skills. The behavioral health care organization has a focus on measurement, learning, and improvement. Staff and behavioral health care providers must be fully engaged in care centered on the individual served and family-centered care as demonstrated by their skills, knowledge, and competence in compassionate communication.

Behavioral health care organizations can adopt a number of strategies to support and improve the activation of individuals served, including promoting culture change, adopting transitional care models, and leveraging health information technology capabilities.34

A number of Joint Commission standards address the rights of the individual served and provide an excellent starting point for behavioral health care organizations seeking to improve the activation of these individuals. These standards require that behavioral health care organizations do the following:

Respect, protect, and promote the rights of the individual (Standard RI.01.01.01RI.01.01.01) Respect the right of the individual served to receive information in a manner he or she understands (Standard RI.01.01.03RI.01.01.03) Respect the right of the individual to participate in decisions about his or her care, treatment, or services (Standard RI.01.02.01RI.01.02.01) Honor the right of the individual to give or withhold informed consent (Standard RI.01.03.01RI.01.03.01) Address decisions about care, treatment, or services received at the end of life with the individual (Standard RI.01.05.01RI.01.05.01) Inform the individual about his or her responsibilities related to his or her care, treatment, or service (Standard RI.02.01.01RI.02.01.01)

Beyond Accreditation: The Joint Commission Is Your Safety Partner To assist behavioral health care organizations on their journey toward creating highly reliable safety systems for individuals, The Joint Commission provides many resources, including the following:

Office of Quality and Patient Safety: An internal Joint Commission department that offers behavioral health care organizations guidance and support when they experience a sentinel event. Organizations can call the Sentinel Event Hotline (630- 792-3700) to clarify whether a safety event is considered to be a sentinel event (and

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therefore reviewable) or to discuss any aspect of the Sentinel Event Policy. The Office of Quality and Patient Safety assesses the thoroughness and credibility of a behavioral health care organization’s comprehensive systematic analysis as well as the action plan to help the organization prevent the hazardous or unsafe conditions from occurring again. Joint Commission Center for Transforming Healthcare: A Joint Commission not-for- profit affiliate that offers highly effective, durable solutions to some of health care’s most critical safety and quality problems to help behavioral health care organizations transform into high reliability organizations. For specific quality and safety issues the Center’s Targeted Solutions Tool® (TST®) guides behavioral health care organizations through a step-by-step process to measure their organization’s performance, identify barriers to excellence, and direct them to proven solutions. Two important TSTs include hand hygiene and hand-off communications. For more information, visit http://www.centerfortransforminghealthcare.org. Standards Interpretation Group: An internal Joint Commission department that helps organizations with their questions about Joint Commission standards. First, organizations can see if other organizations have asked the same question by accessing the Standards FAQs at http://www.jointcommission.org/ standards_information/jcfaq.aspx. Thereafter, organizations can submit questions about standards to the Standards Interpretation Group by completing an online form at https://web.jointcommission.org/sigsubmission/sigonlineform.aspx. National Patient Safety Goals: The Joint Commission’s yearly patient safety requirements based on data obtained from the Joint Commission’s Sentinel Event Database and recommended by a panel of patient safety experts. (For a list of the current National Patient Safety Goals, go to http://www.jointcommission.org/ standards_information/npsgs.) Sentinel Event Alert: The Joint Commission’s periodic alerts with timely infor- mation about similar, frequently reported sentinel events, including root causes, applicable Joint Commission requirements, and suggested actions to prevent a particular sentinel event. (For archives of previously published Sentinel Event Alerts, go to http://www.jointcommission.org/sentinel_event.aspx.) Quick Safety: Quick Safety is a monthly newsletter that outlines an incident, topic, or trend in behavioral health care that could compromise the safety of an individual served. http://www.jointcommission.org/quick_safety.aspx?archieve=y.)

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Joint Commission Resources: A Joint Commission affiliate that produces books and periodicals, holds conferences, provides consulting services, and develops software products (including AMP®, Tracers with AMP®, E-dition®, ECM Plus®, and CMSAccess®) for accreditation and survey readiness. (For more information, visit http://www.jcrinc.com.) Webinars and podcasts: The Joint Commission and its affiliate, Joint Commission Resources, offer free webinars and podcasts on various accreditation and safety topics. Speak Up™ program: The Joint Commission’s campaign to educate individuals served and patients about behavioral health care processes and potential safety issues and encourage them to speak up whenever they have questions or concerns about their safety. (For more information and education resources, go to http:// www.jointcommission.org/speakup.) Standards BoosterPaks™: Available for accredited or certified organizations through The Joint Commission Connect, organizations can access BoosterPaks that provide detailed information about a single standard or topic area that has been associated with a high volume of inquiries or noncompliance scores. Recent standards BoosterPak topics have included credentialing and privileging in nonhospital settings, waived testing, restraint and seclusion, management of hazardous waste, environment of care (including Standards EC.04.01.01EC.04.01.01, EC.04.01.03EC.04.01.03, and EC.04.01.05EC.04.01.05), and sample collection. Leading Practice Library: Available for accredited or certified organizations through The Joint Commission Connect, organizations can access an online library of solutions to help improve safety. The searchable documents in the library are actual solutions that have been successfully implemented by behavioral health care organizations and reviewed by Joint Commission standards experts. Joint Commission web portals: Through the Joint Commission website, organizations can access web portals with a repository of resources from The Joint Commission, the Joint Commission Center for Transforming Healthcare, Joint Commission Resources, and Joint Commission International on the following topics:

Emergency management: http://www.jointcommission.org/emerg ency_management.aspx High reliability: http://www.jointcommission.org/highreliability.aspx Infection prevention and health care–associated infections (HAI): http:// www.jointcommission.org/hai.aspx Transitions of care: http://www.jointcommission.org/toc.aspx

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Workplace violence prevention resources: https://www.jointcommission.org/ workplace_violence.aspx

References 1. Juran J, Godfrey A. Quality Control Handbook, 6th ed. New York: McGraw-Hill,

2010. 2. American Society for Quality. Glossary and Tables for Statistical Quality Control, 4th

ed. Milwaukee: American Society for Quality Press, 2004. 3. Senge PM. The Fifth Discipline: The Art and Practice of the Learning Organization,

2nd ed. New York: Doubleday, 2006. 4. Leape L, et al. A culture of respect, part 2: Creating a culture of respect. Academic

Medicine. 2012 Jul;87(7):853–858. 5. Wu A, ed. The Value of Close Calls in Improving Patient Safety: Learning How to

Avoid and Mitigate Patient Harm. Oak Brook, IL: Joint Commission Resources, 2011.

6. Agency for Healthcare Research and Quality. Becoming a High Reliability Organiza- tion: Operational Advice for Hospital Leaders. Rockville, MD: AHRQ, 2008.

7. Fei K, Vlasses FR. Creating a safety culture through the application of reliability science. J Healthc Qual. 2008 Nov–Dec;30(6):37–43.

8. Massachusetts Coalition of the Prevention of Medical Errors: When Things Go Wrong: Responding to Adverse Events. Mar 2006. Accessed Sep 30, 2013. http:// www.macoalition.org/documents/respondingToAdverseEvents.pdf

9. The Joint Commission. The Joint Commission Leadership Standards. Oak Brook, IL: Joint Commission Resources, 2009.

10. Chassin MR, Loeb JM. High-reliability healthcare: Getting there from here. Milbank Q. 2013 Sep;91(3):459–490.

11. Advisory Committee on the Safety of Nuclear Installations. Study Group on Human Factors. Third Report of the ACSNI Health and Safety Commission. Sudbury, UK: HSE Books, 1993.

12. Leape L, et al. A culture of respect, part 1: The nature and causes of disrepectful behavior by physicians. Academic Medicine. 2012 Jul;87(7):1–8.

13. Weick KE, Sutcliffe KM. Managing the Unexpected, 2nd ed. San Francisco: Jossey- Bass, 2007.

14. Reason J, Hobbs A. Managing Maintenance Error: A Practical Guide. Aldershot, UK: Ashgate, 2003.

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Association for the Advancement of Medical Instrumentation. Risk and Reliability in Healthcare and Nuclear Power: Learning from Each Other. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2013. Reason J. Human error: Models and management. BMJ. 2000 Mar 13;320(3):768– 770. The Joint Commission: Behaviors that undermine a culture of safety. Sentinel Event Alert. 2009 Jul 9. Accessed Sep. 3, 2013. http://www.jointcommission.org/ sentinel_event_alert_issue_40_behaviors_that_undermine_a_culture_of_safety/ Institute for Safe Medication Practices. Unresolved disrespectful behavior in health care: Practitioners speak up (again)—Part I. ISMP Medication Safety Alert. Oct 3, 2013. Accessed Sep 18, 2014. http://www.ismp.org/Newsletters/acutecare/ showarticle.aspx?id=60 Chassin MR, Loeb JM. The ongoing quality journey: Next stop high reliability. Health Affairs. 2011 Apr 7;30(4):559–568. Heifetz R, Linsky M. A survival guide for leaders. Harvard Business Review. 2002 Jun;1–11. Ontario Hospital Association. A Guidebook to Patient Safety Leading Practices: 2010. Toronto: Ontario Hospital Association, 2010. The Joint Commission. Leadership committed to safety. Sentinel Event Alert. Aug 27, 2009. Accessed Aug 26, 2013. http://www.jointcommission.org/ sentinel_event_alert_issue_43_leadership_committed_to_safety/ Ogrinc GS, et al. Fundamentals of Health Care Improvement: A Guide to Improving Your Patients’ Care, 2nd ed. Oak Brook, IL: Joint Commission Resources/Institute for Healthcare Improvement, 2012. Agency for Healthcare Research and Quality. Becoming a High Reliability Organiza- tion: Operational Advice for Hospital Leaders. Rockville, MD: AHRQ, 2008. Joint Commission Resources. Patient Safety Initiative: Hospital Executive and Physician Leadership Strategies. Hospital Engagement Network. Oak Brook, IL: Joint Commission Resources, 2013. Accessed Sep 12, 2013. https://www.jcr-hen.org/pub/ Home/CalendarEvent00312/JCR_Hen_Leadership_Change_Package-FINAL.pdf The Joint Commission. Leadership committed to safety. Sentinel Event Alert. Aug 27, 2009. Accessed Sep 8, 2013. http://www.jointcommission.org/ sentinel_event_alert_issue_43_leadership_committed_to_safety Nelson EC, et al. Microsystems in health care: Part 2. Creating a rich information environment. Jt Comm J Qual Patient Saf. 2003 Jan;29(1):5–15. Nelson EC, et al. Clinical microsystems, part 1. The building blocks of health systems. Jt Comm J Qual Patient Saf. 2008 Jul;34(7):367–378.

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29. Pardini-Kiely K, et al. Improving and sustaining core measure performance through effective accountability of clinical microsystems in an academic medical center. Jt Comm J Qual Patient Saf. 2010 Sep;36(9):387–398.

30. Diller T, et al. The human factors analysis classification system (HFACS) applied to health care. Am J Med Qual. 2014 May–Jun;29(3)181–190.

31. Croteau RJ, ed. Root Cause Analysis in Health Care: Tools and Techniques, 4th ed. Oak Brook, IL: Joint Commission Resources, 2010.

32. AARP Public Policy Institute. Beyond 50.09 chronic care: A call to action for health reform. Mar 2009. Accessed Jun 6, 2014. http://www.aarp.org/health/medicare -insurance/info-03-2009/beyond_50_hcr.html

33. Towle A, Godolphin W. Framework for teaching and learning informed shared decision making. BMJ. 1999 Sep 18;319(7212):766–771.

34. Hibbard JH, et al. Development of the patient activation measure (PAM): Conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005–1026.

Appendix. Key Safety Systems Requirements A number of Joint Commission standards have been discussed in the “Safety Systems for Individuals Served” (SSIS) chapter. However, many Joint Commission requirements address issues related to the design and management of safety systems, including the following examples.

Environment of Care (EC) Standard EC.04.01.01 The organization collects information to monitor conditions in the environment.

Elements of Performance for EC.04.01.01 1. The organization establishes a process(es) for continually monitoring, internally

reporting, and investigating the following: Injuries to individuals served or others within the organization’s facilities Occupational illnesses and staff injuries

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Incidents of damage to its property or the property of others in locations it controls Security incidents involving individuals served, staff, or others in locations it controls Fire safety management problems, deficiencies, and failures

NoteNote 1:1: All the incidents and issues listed above may be reported to staff in quality assessment, improvement, or other functions. A summary of such incidents may also be shared with the person designated to coordinate safety management activities.

NoteNote 2:2: Review of incident reports often requires that legal processes be followed to preserve confidentiality. Opportunities to improve care, treatment, or services, or to prevent similar incidents, are not lost as a result of following the legal process.

Based on its process(es), the organization reports and investigates the following:

2. Problems and incidents related to each of the environment of care management plans.

3. Injuries to individuals served or others within the organization’s facilities.

4. Occupational illnesses and staff injuries.

Note:Note: This requirement applies to issues in the workplace, such as back injuries or allergies. It does not apply to communicable diseases.

5. Incidents of damage to its property or the property of others in locations it controls.

14. The organization monitors environmental deficiencies, hazards, and unsafe practices.

15. Every 12 months, the organization evaluates each environment of care management plan, including a review of the plan’s objectives, scope, perform- ance, and effectiveness.

Note:Note: By evaluating the management plans, the organization can make sure that they remain relevant and useful guides for managing the environment of care. A review of the plans’ scope includes a determination of whether any new services, programs, or sites added in the past year need to be addressed by the plans or if new hazards have been introduced into the environment that now need to be covered. A review of the plans’ effectiveness could be accomplished through a review of incident reports as well as evaluation of other known problems that are not found on the incident reports

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(such as problems identified in the critique of a fire drill). A review of the plans’ objectives would include a determination of whether the previous year’s objectives were met and if any new objectives should be established to address problems identified in the review of the plans’ effectiveness.

Standard EC.04.01.03 The organization analyzes identified environment of care issues.

Element of Performance for EC.04.01.03 2. The organization uses the results of data analysis to identify opportunities to

resolve environmental safety issues.

Standard EC.04.01.05 The organization improves its environment of care.

Element of Performance for EC.04.01.05 1. The organization takes action on the identified opportunities to resolve

environmental safety issues.

Infection Prevention and Control (IC) Standard IC.01.03.01 The organization identifies risks for acquiring and spreading infections.

Elements of Performance for IC.01.03.01 1. The organization identifies infection risks based on the following:

Its setting and population served The care, treatment, or services it provides ForFor 24-hour24-hour carecare settings:settings: Its monitoring of infection prevention and control activities and/or tracking and analyzing the occurrence of infections

NoteNote 1:1: The infections that should be tracked are those that are most relevant to the organization’s setting, services, and population(s). The organization may contact its local health department for statistics and other information on some infections, and track other infections internally. For example, an organization may decide to track conjunctivitis itself but rely on health department statistics related to tuberculosis.

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NoteNote 2:2: The risk of infection will vary across behavioral health care settings. For example, infection risks in group homes, day treatment programs, and couples counseling will vary by hours of contact, number of individuals served, and location and type of service.

3. The organization establishes priorities among the risks it identified. The organization documents priority risk(s).

Leadership (LD) Standard LD.03.01.01 Leaders create and maintain a culture of safety and quality throughout the organization.

Elements of Performance for LD.03.01.01 1. Leaders regularly evaluate the culture of safety and quality.

2. Leaders prioritize and implement changes identified by the evaluation.

4. Leaders develop a code of conduct that defines acceptable behavior and behaviors that undermine a culture of safety.

5. Leaders create and implement a process for managing behaviors that undermine a culture of safety.

8. All who work in the organization are able to openly discuss issues of safety and quality. (See also LD.04.04.05, EP 6)

Standard LD.03.02.01 The organization uses data and information to guide decisions and to understand variation in the performance of processes supporting safety and quality.

Elements of Performance for LD.03.02.01 1. Leaders set expectations for using data and information to improve the safety and

quality of care, treatment, or services.

2. Leaders are able to describe how data and information are used to create a culture of safety and quality.

3. The organization uses processes to support systematic data and information use.

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4. Leaders provide the resources needed for data and information use, including staff, equipment, and information systems.

5. The organization uses data and information in decision making that supports the safety and quality of care, treatment, or services. (See also PI.02.01.01, EP 8)

6. The organization uses data and information to identify and respond to internal and external changes in the environment.

7. Leaders evaluate how effectively data and information are used throughout the organization.

Standard LD.03.04.01 The organization communicates information related to safety and quality to those who need it, including staff, individuals served, families, and external interested parties.

Elements of Performance for LD.03.04.01 1. Communication processes foster the safety of the individual served and the

quality of care.

2. Leaders are able to describe how communication supports a culture of safety and quality.

3. Communication is designed to meet the needs of internal and external users.

4. Leaders provide the resources required for communication, based on the needs of individuals served, staff, and administration.

5. Communication supports safety and quality throughout the organization. (See also LD.04.04.05, EPs 6 and 12)

6. When changes in the environment occur, the organization communicates those changes effectively.

7. Leaders evaluate the effectiveness of communication methods.

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Standard LD.03.05.01 Leaders implement changes in existing processes to improve the performance of the organization.

Elements of Performance for LD.03.05.01 4. Leaders provide the resources required for performance improvement and change

management, including sufficient staff, access to information, and training.

Standard LD.04.01.05 The organization effectively manages its programs or services.

Elements of Performance for LD.04.01.05 4. Staff are held accountable for their responsibilities.

Standard LD.04.04.01 Leaders establish priorities for performance improvement. (Refer to the “Performance Improvement” [PI] chapter.)

Elements of Performance for LD.04.04.01 1. Leaders set priorities for performance improvement activities and behavioral

health outcomes. (See also PI.01.01.01, EPs 1 and 3)

2. Leaders give priority to high-volume, high-risk, or problem-prone processes for performance improvement activities. (See also PI.01.01.01, EPs 14, 15, and 27)

3. Leaders reprioritize performance improvement activities in response to changes in the internal or external environment.

4. Performance improvement occurs organizationwide.

24. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: Leaders set priorities for physical health care performance improvement activities and outcomes. (See also PI.01.01.01, EP 40)

Note:Note: As an example, activities and outcomes may be related to individuals with multiple chronic physical health conditions.

25. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: Leaders involve individuals served in performance improvement activities related to integrated care.

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Note:Note: This involvement may include activities such as participating on a quality committee or providing feedback on safety and quality issues.

Standard LD.04.04.05 The organization has an organizationwide, integrated safety program for individuals served.

Elements of Performance for LD.04.04.05 1. The leaders implement an organizationwide safety program for individuals

served.

2. One or more qualified persons manage the safety program.

3. The scope of the safety program includes the full range of safety issues, from potential or no-harm errors (sometimes referred to as close calls [“near misses”] or good catches) to hazardous conditions and sentinel events.

4. All programs and services within the organization participate in the safety program.

5. As part of the safety program, the leaders create procedures for responding to system or process failures.

NoteNote 1:1: Responses might include continuing to provide care, treatment, or services to those affected, containing the risk to others, and preserving factual information for subsequent analysis.

NoteNote 2:2: ForFor opioidopioid treatmenttreatment programs:programs: Examples of reportable patient deaths include the following:

Drug-related deaths Methadone or buprenorphine deaths Unexpected or suspicious deaths Treatment-context deaths that raise individual, family, community, or public concern

6. The leaders provide and encourage the use of systems for blame-free internal reporting of a system or process failure, or the results of a proactive risk assessment. (See also LD.03.01.01, EP 8; LD.03.04.01, EP 5; LD.04.04.03, EP 3)

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Note:Note: This EP is intended to minimize staff reluctance to report errors in order to help an organization understand the source and results of system and process failures. The EP does not conflict with holding individuals accountable for their blameworthy errors.

7. The leaders define patient safety event and communicate this definition throughout the organization.

Note:Note: At a minimum, the organization’s definition includes those events subject to review in the “Sentinel Events” (SE) chapter of this manual. The definition may include any process variation that does not affect the outcome or result in an adverse event, but for which a recurrence carries significant chance of resulting in a serious adverse outcome or an adverse event, often referred to as a close call or near miss.

8. The organization conducts thorough and credible comprehensive systematic analyses (for example, root cause analyses) in response to sentinel events as described in the “Sentinel Events” (SE) chapter of this manual.

9. The leaders make support systems available for staff who have been involved in an adverse or sentinel event.

Note:Note: Support systems recognize that conscientious health care workers who are involved in sentinel events are themselves victims of the event and require support. Support systems provide staff with additional help and support as well as additional resources through the human resources function or an employee assistance program. Support systems also focus on the process rather than blaming the involved persons.

11. To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.04.04.03, EP 3)

12. The leaders disseminate lessons learned from comprehensive systematic analyses (for example, root cause analyses), system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation. (See also LD.03.04.01, EP 5)

13. At least once a year, the leaders provide governance with written reports on the following:

All system or process failures The number and type of sentinel events Whether the individuals served and the families were informed of the event

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All actions taken to improve safety, both proactively and in response to actual occurrences

14. The leaders encourage external reporting of significant adverse events, including voluntary reporting programs in addition to mandatory programs.

Note:Note: Examples of voluntary programs include The Joint Commission Sentinel Event Database and the US Food and Drug Administration (FDA) MedWatch. Mandatory programs are often state initiated.

Medication Management (MM) Standard MM.08.01.01 The organization evaluates the effectiveness of its medication management system.

NoteNote 1:1: This evaluation includes reconciling medication information. (Refer to NPSG.03.06.01 for more information)

NoteNote 2:2: This standard is applicable only to organizations that prescribe, dispense, or administer medications.

Elements of Performance for MM.08.01.01 1. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: The

organization collects data on the performance of its medication management system. (See also PI.01.01.01, EPs 14 and 15)

Note:Note: This element of performance is also applicable to sample medications.

2. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: The organization analyzes data on its medication management system.

Note:Note: This element of performance is also applicable to sample medications.

3. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: The organization compares data over time to identify risk points, levels of performance, patterns, trends, and variations of its medication management system.

Note:Note: This element of performance is also applicable to sample medications.

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5. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: Based on analysis of its data, the organization identifies opportunities for improvement in its medication management system.

6. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: The organization takes action on improvement opportunities identified as priorities for its medication management system. (See also PI.03.01.01, EP 2)

Note:Note: This element of performance is also applicable to sample medications.

7. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: The organization evaluates its actions to confirm that they resulted in improvements for its medication management system.

8. ForFor organizationsorganizations thatthat prescribe,prescribe, dispense,dispense, oror administeradminister medications:medications: The organization takes additional action when planned improvements for its medication management processes are either not achieved or not sustained.

16. When automatic dispensing cabinets (ADCs) are used, the organization has a policy that describes the types of medication overrides that will be reviewed for appropriateness and the frequency of the reviews. A 100% review of overrides is not required.

Performance Improvement (PI) Standard PI.01.01.01 The organization collects data to monitor its performance.

Elements of Performance for PI.01.01.01 1. The leaders set priorities for data collection. (See also LD.04.04.01, EP 1)

2. The organization identifies the frequency for data collection.

The organization collects data on the following:

3. Performance improvement priorities identified by leaders. (See also LD.04.04.01, EP 1)

14. Significant medication errors. (See also LD.04.04.01, EP 2; MM.08.01.01, EP 1)

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15. Significant adverse medication reactions. (See also LD.04.04.01, EP 2; MM.08.01.01, EP 1)

16. The organization collects data on the following: Whether the individual served was asked about treatment goals and needs Whether the individual served was asked if his or her treatment goals and needs were met The view of the individual served regarding how the organization can improve the safety of the care, treatment, or services provided

(See also RI.01.01.01, EP 17, for opioid treatment programs)

27. The organization collects data to measure the performance of high-risk, high- volume, problem-prone processes provided to high-risk or vulnerable popu- lations, as defined by the organization. (See also LD.04.04.01, EP 2)

Note:Note: Examples of such processes include the use of restraints, seclusion, suicide watch, and behavior management and treatment.

31. ForFor fosterfoster care:care: The agency collects data on its performance, including the safety of the placement and the maintenance or improvement of the individual’s level of functioning.

32. ForFor fosterfoster care:care: The agency collects data on the permanency of the placement and the permanency of outcome when they are within the organization’s scope of services.

37. ForFor opioidopioid treatmenttreatment programs:programs: The program collects data about treatment outcomes and processes.

Note:Note: Examples of data collected include the following: Use of illicit opioids, illegal drugs, and the problematic use of alcohol and prescription medications Criminal activities and entry into the criminal justice system Behaviors contributing to the spread of infectious diseases Restoration of physical and mental health and functional status Retention in treatment Number of patients who are employed Abstinence from drugs of abuse

ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization collects data on the following:

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40. Disease management outcomes. (See also LD.04.04.01, EP 24)

41. The individual’s access to care within time frames established by the organization.

42. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization collects data on the following:

The individual’s experience and satisfaction related to access to care, treatment, or services and communication The individual’s perception of the comprehensiveness of care, treatment, or services The individual’s perception of the coordination of care, treatment, or services The individual’s perception of the continuity of care, treatment, or services

(Refer to PI.01.01.01, EP 16)

43. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: All staff who are part of the behavioral health home actively participate in performance improvement activities.

48. ForFor organizationsorganizations thatthat provideprovide eatingeating disordersdisorders care,care, treatment,treatment, oror services:services: The organization collects data about care, treatment, or services outcomes. Examples of such data include the following:

If conducting follow-ups, confirmation of whether the individual is engaged in aftercare services and, if so, the type and frequency of those services. Data collected from valid and reliable instruments used at admission and discharge that are self-administered by individuals served. Examples of such instruments include the Beck Depression Inventory (BDI), Eating Disorder Quality of Life (EDQOL), the SF-36, and Eating Disorder Inventory-3 (EDI-3). Data collected from individuals’ satisfaction questionnaires.

Standard PI.03.01.01 The organization improves performance.

Elements of Performance for PI.03.01.01 2. The organization takes action on improvement priorities. (See also MM.08.01.01,

EP 6)

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4. The organization takes action when it does not achieve or sustain planned improvements.

11. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization uses the data it collects on the individual’s perception of the safety and quality of care, treatment, or services to improve its performance. This data includes the following:

The individual’s experience and satisfaction related to access to care, treatment, or services and communication The individual’s perception of the comprehensiveness of care, treatment, or services The individual’s perception of the coordination of care, treatment, or services The individual’s perception of the continuity of care, treatment, or services

Record of Care, Treatment, and Services (RC) Standard RC.02.01.05 The clinical/case record contains documentation of the use of restraint and/or seclusion and documentation of physical holding of a child or youth.

Elements of Performance for RC.02.01.05 3. The organization documents the use of restraint and/or seclusion for behavioral

health purposes in the clinical/case record, including the following: Each episode of restraint and/or seclusion The circumstances that led to the use of restraint and/or seclusion Consideration or failure of nonphysical interventions The rationale for the type of physical intervention used Written orders for the use of restraint and/or seclusion Each verbal order received from a licensed independent practitioner Each in-person evaluation and reevaluation of the individual served Each 15-minute assessment of the status of the individual served Continuous monitoring of the individual served Any preexisting medical conditions or any physical disabilities that would place the individual served at greater risk during restraint and/or seclusion Any history of sexual or physical abuse that would place the individual at greater psychological risk during restraint and/or seclusion

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That the individual served and/or his or her family was informed of the organization’s policy on the use of behavioral restraint and/or seclusion That the individual served was notified of the use of restraint and/or seclusion Behavior criteria for discontinuing restraint and/or seclusion That the individual served was informed of the behavior criteria he or she needed to meet in order for restraint and/or seclusion to be discontinued Assistance provided to the individual served to help him or her meet the behavior criteria for discontinuing the use of restraint and/or seclusion Debriefing the individual served with staff following an episode of restraint and/or seclusion Any injuries the individual served sustained and the treatment for these injuries The death of the individual served while in restraint or seclusion

4. The method(s) used to document restraint and/or seclusion facilitates the collection and analysis of data for performance improvement activities.

5. The organization documents the use of physical holding of a child or youth for behavioral health purposes in the clinical/case record, including the following:

Each episode of physical holding The circumstances that led to the use of physical holding Attempt at or failure of nonphysical interventions The rationale for the use of physical holding Names of the staff members who participated in the use of physical holding, including who did the holding and who observed the child’s or youth’s physical well-being Any preexisting medical conditions or any physical disabilities that would place the individual served at greater risk during physical holding Any history of sexual or physical abuse or other trauma that would place the individual at greater psychological risk during physical holding That the individual served and/or his or her family was informed of the organization’s policy on the use of physical holding That the individual’s parent(s) or guardian was notified of the use of physical holding Behavior criteria for discontinuing physical holding That the individual served was informed of the behavior criteria he or she needed to meet in order for physical holding to be discontinued

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Assistance provided to the individual served to help him or her meet the behavior criteria for discontinuing the use of physical holding Debriefing the individual served with staff following an episode of physical holding Any injuries the individual served sustained and the treatment for these injuries The death of the individual served while in a physical hold

6. The method(s) used to document physical holding facilitates the collection and analysis of data for performance improvement activities.

Rights and Responsibilities of the Individual (RI) Standard RI.01.01.01 The organization respects the rights of the individual served.

Elements of Performance for RI.01.01.01 1. The organization has written policies on the rights of the individual served.

2. The organization informs the individual served of his or her rights. (See also RI.01.01.03, EPs 1–3)

3. If an individual served is disoriented or lacks capacity to understand rights at the time of entry, he or she is informed again when he or she is able to understand.

4. The organization treats the individual served in a respectful manner that supports his or her dignity.

6. The organization respects the cultural and personal values, beliefs, and prefer- ences of the individual served.

7. The organization respects the right of the individual served to privacy. (See also IM.02.01.01, EPs 1–4)

Note:Note: This element of performance (EP) addresses the personal privacy of the individual served. For EPs addressing security and safety, please see EC.02.01.01, EP 3 and EC.02.06.01, EP 1. For EPs addressing the privacy of health information, please refer to Standard IM.02.01.01.

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9. In 24-hour settings, the organization accommodates the right of the individual to pastoral and other spiritual services.

Note:Note: The spiritual services of individuals are varied and may take place in the setting or outside of the setting, and may require special considerations regarding scheduling, space, or other accommodations. Within its capabilities, the organization accommodates this right.

10. In accordance with law and regulation, the organization allows the individual served to access and request amendment to his or her health information and to obtain information on disclosures of this information.

14. ForFor opioidopioid treatmenttreatment programs:programs: The program reviews rights and responsibilities with the patient at admission, at the end of the stabilization period, and when any changes have been made to the list of rights and responsibilities.

15. ForFor opioidopioid treatmenttreatment programs:programs: The program treats women respectfully and safely.

16. ForFor opioidopioid treatmenttreatment programs:programs: The medication schedule (dosing times/program hours) is the least intrusive and disruptive schedule for the majority of patients.

17. ForFor opioidopioid treatmenttreatment programs:programs: Satisfaction surveys allow patients to provide feedback on program policies and services. (See also PI.01.01.01, EP 16)

18. In 24-hour settings, individuals served are informed about the organization’s policies and procedures regarding the handling of medical emergencies. (See also RI.01.02.01, EP 2)

20. ForFor opioidopioid treatmenttreatment programs:programs: The program obtains written acknowledge- ment from patients that they received a copy of their rights and that these rights were discussed with them.

22. The organization informs the individual served of the program rules.

24. ForFor opioidopioid treatmenttreatment programs:programs: The program informs patients about the financial aspects of treatment, including the consequence of nonpayment of fees.

25. ForFor opioidopioid treatmenttreatment programs:programs: The program posts patients’ rights and responsibilities at the treatment site in a manner that makes the posting visible to patients.

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26. ForFor opioidopioid treatmenttreatment programs:programs: The program informs patients upon admission about its obligation under state-specific requirements and its own policies and procedures to report suspected child abuse and neglect and other forms of abuse (such as violence against women).

30. ForFor organizationsorganizations thatthat provideprovide 24-hour24-hour eatingeating disordersdisorders care,care, treatment,treatment, oror services:services: The organization has a policy addressing those situations, if any, in which minors are permitted to leave the facility.

31. ForFor organizationsorganizations thatthat provideprovide 24-hour24-hour eatingeating disordersdisorders care,care, treatment,treatment, oror services:services: The organization obtains consent from a minor’s parent or guardian for the minor to have visitors.

32. ForFor organizationsorganizations thatthat provideprovide 24-hour24-hour eatingeating disordersdisorders care,care, treatment,treatment, oror services:services: The organization has a policy on Internet access for individuals served.

Standard RI.01.01.03 The organization respects the right of the individual served to receive information in a manner he or she understands.

Elements of Performance for RI.01.01.03 1. The organization provides information to the individual served in a manner

tailored to his or her language and ability to understand. (See also CTS.06.02.03, EP 9; RI.01.01.01, EP 2)

2. The organization provides interpreting and translation services, as necessary. (See also RI.01.01.01, EP 2)

Note:Note: ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: Language interpreting options may include trained bilingual staff, contract interpreting services, or employed language interpreters. These options may be provided in person or via telephone or video. The documents that are translated, and the languages into which they are translated, are dependent on the population(s) served by the organization.

3. The organization communicates with the individual served who has vision, speech, hearing, or cognitive impairments in a manner that meets the needs of that individual. (See also RI.01.01.01, EP 2)

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Standard RI.01.02.01 The organization respects the right of the individual served to collaborate in decisions about his or her care, treatment, or services.

Elements of Performance for RI.01.02.01 1. The organization involves the individual served in making decisions about his or

her care, treatment, or services.

Note:Note: This involvement goes beyond mere presence at the time of discussion or decision making. Involvement connotes a collaborative process in which the organization actively engages the individual served in decision making regarding his or her care, treatment, or services.

2. When an individual served is unable to make decisions about his or her care, treatment, or services, or chooses to delegate decision making to another, the organization involves the surrogate decision maker in making these decisions. (See also RI.01.03.01, EP 1; RI.01.01.01, EP 18)

4. The organization respects the right of the individual served or surrogate decision maker to refuse care, treatment, or services, in accordance with law and regulation.

5. When an individual refuses care, treatment, or services, the organization fully informs the individual about its responsibility, in accordance with professional standards, to terminate the relationship with the individual upon reasonable notice, or to seek orders for involuntary treatment or other legal alternatives.

8. The individual served has the right to involve his or her family in decisions about care, treatment, or services. When there is a surrogate decision-maker, he or she can exercise the right to involve the family on behalf of the individual served, in accordance with law and regulation. (See also RI.01.07.01, EP 2; CTS.04.02.16, EP 5)

9. The organization accommodates the right of the individual served to request the opinion of a consultant.

Note:Note: This element of performance does not require the organization to pay for consultant services.

10. The organization accommodates the right of the individual served to request an internal review of his or her plan of care, treatment, or services.

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11. The organization has a process for resolving disagreements about therapeutic issues.

20. The organization provides the individual served or surrogate decision-maker with the information about the following:

Outcomes of care, treatment, or services that the individual needs in order to participate in current and future behavioral health care decisions Unanticipated events related to the individual’s care, treatment, or services that are sentinel events as defined by The Joint Commission (Refer to the Glossary for a definition of sentinel event.)

28. ForFor opioidopioid treatmenttreatment programs:programs: The program allows for patient choice in seeking alternative therapies and provides support to patients who choose to explore these alternatives.

Note:Note: Programs may provide culturally appropriate or popular and nonharmful alternative therapies, such as acupuncture or providing a space for a sweat lodge.

31. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization provides the individual served or surrogate decision- maker with the information about the outcomes of care, treatment, or services that the individual needs in order to participate in current and future physical health care decisions.

32. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization respects the individual’s right to make decisions about the management of his or her care, treatment, or services.

33. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization respects the individual’s right and provides him or her the opportunity to do the following:

Obtain care from other clinicians of the individual’s choosing within the behavioral health home Seek a second opinion from a clinician of the individual’s choosing Seek specialty care

Note:Note: This element of performance does not imply financial responsibility on the part of the organization for any activities associated with these rights.

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34. ForFor opioidopioid treatmenttreatment programs:programs: The program provides the patient with information about providers in the community who are able to address any of the patient’s needs that the program cannot meet.

35. ForFor opioidopioid treatmenttreatment programs:programs: The program provides the patient with information about providers in the community should the patient be dissatisfied with the services received from the program.

Standard RI.01.03.01 The organization honors the right of the individual served to give or withhold informed consent.

Elements of Performance for RI.01.03.01 1. The organization follows a written policy on informed consent that describes

the following: The specific care, treatment, or services that require informed consent Circumstances that would allow for exceptions to obtaining informed consent, such as situations involving threat of harm to self or others, child abuse, or elder abuse When a surrogate decision-maker may give informed consent (See also RI.01.02.01, EP 2)

2. The informed consent process includes a discussion about the following: The proposed care, treatment, or services for the individual served. The goals and potential benefits and risks of the proposed care, treatment, or services. Reasonable alternatives to the individual’s proposed care, treatment, or services. The discussion encompasses risks and benefits related to the alternatives and the risks related to not receiving the proposed care, treatment, or services.

3. The organization obtains and documents informed consent in advance if it makes and uses recordings, films, or other images of individuals served for internal use other than the identification, diagnosis, or treatment of the individual (for example, performance improvement and education). This informed consent includes an explanation of how the recordings, films, or other images will be used.

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NoteNote 1:1: The term “recordings, films, or other images” refers to photographic, video, digital, electronic, or audio media.

NoteNote 2:2: This element of performance does not apply to the use of security cameras.

16. ForFor opioidopioid treatmenttreatment programs:programs: Before administering medication, the program obtains voluntary, written, informed consent from the patient for the prescribed medication-assisted treatment. The program’s informed consent policy makes certain that each patient voluntarily chooses maintenance treatment and that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the patient. Within 30 days post-admission, an appropriate program staff member reviews all relevant facts concerning the use of the opioid drug with the patient.

17. ForFor opioidopioid treatmenttreatment programs:programs: The program informs patients that the goal of medication-assisted treatment is to stabilize functioning.

18. ForFor opioidopioid treatmenttreatment programs:programs: The program informs patients that the provider will periodically discuss with them their present level of functioning, course of treatment, and future goals.

Note:Note: These discussions are not intended to place pressure on the patient to either withdraw from medication or remain on medication maintenance.

19. ForFor opioidopioid treatmenttreatment programs:programs: Patients are informed about their disease’s natural progression, including statistics about success after withdrawing from methadone.

20. ForFor opioidopioid treatmenttreatment programs:programs: The program informs patients about potential medication interactions with and adverse reactions to other substances, including those related to the use of alcohol, licit and illicit drugs, other prescribed or over- the-counter pharmacological agents, other medical procedures, and food.

Note:Note: The program should provide the patient with information about potential medication interactions throughout the course of care, treatment, or services, such as at the time of the treatment plan review and at the time there are changes to the patient’s medication dose.

21. ForFor opioidopioid treatmenttreatment programs:programs: The program informs all pregnant patients with concurrent HIV infection that HIV medication treatment is currently rec- ommended to reduce perinatal transmission, and it provides pregnant patients with appropriate referrals and case management for this treatment.

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Standard RI.01.05.01 ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: The organization addresses decisions made by the individual served about physical health care, treatment, or services received at the end of life. (For more information, refer to Standard CTS.01.04.01.)

Elements of Performance for RI.01.05.01 1. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome

option:option: The organization follows a written policy on physical health advance directives that address the following:

Whether the organization will honor physical health advance directives Communicating its policy on physical health advance directives to the individuals it serves ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: Informing all members of the integrated care team when an individual served has a physical health advance directive, and how to access it

10. ForFor organizationsorganizations thatthat electelect TheThe JointJoint CommissionCommission BehavioralBehavioral HealthHealth HomeHome option:option: Upon request, the organization shares with the individual possible sources of help in formulating physical health advance directives.

Standard RI.02.01.01 The organization informs the individual served about his or her responsibilities related to his or her care, treatment, or services.

Elements of Performance for RI.02.01.01 2. The organization informs the individual served about his or her responsibilities.

Note:Note: Information about the individual’s responsibilities can be shared verbally, in writing, or both.

3. ForFor opioidopioid treatmenttreatment programs:programs: The program obtains written acknowledge- ment from the patient that patient responsibilities were explained.