Manage sentinel events by fixing root causes
Reduce errors, define your policy
By Patrice Spath, ART
Consultant in Health Care Quality and Resource Management
Forest Grove, OR
It’s sad but true that most, if not all, sentinel events in health care occur as a result of compounded inadequacies in a number of managerial areas. Some of these issues are things that individual managers can fix themselves, while many will require involvement of the organization’s leaders. During a root-cause analysis of sentinel events, the investigation team should closely evaluate the management systems underlying the apparent or proximate cause of the sentinel event. The questions below can be used by the team to unearth management/supervision inadequacies that may have contributed to the sentinel event.
Do managers/supervisors provide:
• necessary help and training for subordinates?
• sufficient time to communicate with subordinates?
• necessary hardware and software?
• advice regarding the hazards and risks involved in the job?
• properly qualified staff in the case of:
temporary or permanent personnel replacement or transfer within the department (vacation, sickness, etc.)?
float staff?
• necessary information, training, and technical backup to permit staff to detect hazardous situations?
• assignments of responsibility that will lead to reporting and correction of hazardous situations?
• review of operational readiness during initial start of new processes and restart after significant changes?
• periodic review for operational readiness of ongoing processes?
• control of safety-related errors by requiring:
proper task assignment?
use of safe practices?
briefing sessions before new high-risk processes are implemented?
• attention to staff’s personal factors that may increase the incidence of errors?
• support for staff’s training needs?
• attention to the department’s error rates?
• information to be given to staff about the consequences of errors?
Does environment support error reduction?
The effectiveness of top management’s support of basic organizational safety policies should also be evaluated during a sentinel event root-cause analysis. To minimize the likelihood of a sentinel event, the facility’s leaders must provide a place of employment that is free from hazards that are likely to cause death, serious physical harm, or illness to patients. In addition to furnishing a safe environment for employees and patients, the organization’s leaders must visibly support a climate in which error reduction is valued. Error reduction cannot be viewed as a "program of the month" or the title of a quarterly newsletter. Complete commitment to error reduction means the organization’s leaders must make a personal decision to follow through on an agreed-upon plan of action. Physicians and staff will be committed to error reduction to the extent that leadership is committed. The questions below can be used by the sentinel event investigation team in its appraisal of the effect of organizational/ cultural issues on the occurrence of the event.
• Did vertical and horizontal lines of interface, communication, and support have any impact on the sentinel event?
• Do managers and supervisors have sufficient authority, staffing, and support to implement assigned responsibilities, analyses, and decisions relative to the event-related processes?
• Are physicians, staff, and managers empowered to take appropriate actions when potential patient care hazards are recognized?
• Can physicians/staff refuse to participate in a task or activity when they perceive that unsafe conditions exist, without fear of reprisal?
• Has a process been developed and implemented to allow physicians/staff to raise quality-related issues?
• Has management established and implemented a quality-conscious culture?
• Are physicians/staff encouraged to participate and become involved in quality management activities?
• Did a lack of physician/staff participation in raising quality issues impact the proximate or root causes of the sentinel event?
When the management-related root causes of a sentinel event are fixed, overall performance of everyone in the facility is likely to improve.
Organizational sentinel event policy
The standards of the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, do not require that a facility have a written sentinel event policy. While some organizations have chosen to write a separate policy, it may be just as effective to include a discussion of sentinel event issues in the facilitywide quality management or risk management plan.
Listed below are elements related to sentinel events that need to be considered by an organization. The answers should be agreed upon by all involved leaders administrative and medical staff. The conclusions can be incorporated into your organizationwide quality management plan or documented in a separate sentinel event policy.
• What is your definition of a "sentinel event"?
In some instances, the answer to this question may be already well-defined in your risk management program. If not, a facilitywide definition needs to be developed. A sample definition from one hospital reads thus: "A sentinel event is an unexpected occurrence that results in a serious, undesirable, and unexpected patient outcome that involves the loss of patient life, limb, or function or has the potential to adversely affect the good name or reputation of the facility."
Some organizations also consider an event to be sentinel if it is reportable to an external agency. This clause in your sentinel event definition may significantly broaden the intent, because many types of events are reported by a health care facility to external groups. For example:
Deaths related to blood transfusions must be reported to the Food and Drug Administration (FDA) within seven days of the event.
Incidents in which a medical device may have caused or contributed to the death of a patient or employee of the facility must be reported to the FDA and the manufacturer within 10 days of the event.
Physicians, pharmacists, and other health care professionals are encouraged to voluntarily report "adverse drug experiences" to the FDA.
Hospitals and other health care entities must report to the National Practitioner Data Bank any professional review actions, based on physician’s or dentist’s professional competence or conduct, that adversely affects the physician’s or dentist’s clinical privileges for more than 30 days.
Accidents or irregularities involving radioactive agents must be reported to the Nuclear Regulatory Commission.
Some states (such as Florida and New York) have enacted laws requiring reporting of significant patient care occurrences to a state agency.
• Resolve procedural issues.
The organization should determine who is responsible for receiving notifications of sentinel events. This may be the quality management department, the safety officer, the risk manager, or an administrative/medical staff leader. Whoever is responsible should be able to quickly perform an initial assessment of the event to determine if more "intense assessment" needs to occur. If the original recipient of the notice is not the same person who will perform the initial assessment, systems must be put in place to share information.
Will all sentinel events be investigated using formal root-cause analysis techniques? If the organization’s definition of a sentinel event is broad, it may not wish to conduct a root cause analysis of every event. Consider using the "Accreditation Watch" criteria of the Joint Commission when selecting events for root-cause analysis. The Joint Commission has issued criteria that are used to determine if the Commission will put a health care organization on "Accreditation Watch" status following a sentinel event. Two of the three criteria below must be met:1
1. The incident results in a patient’s unexpected death or permanent loss of function.
2. The incident significantly deviates from the hospital’s usual process for providing health care services.
3. The incident either undermined or potentially could undermine public confidence.
These criteria describe a subcategory of an "important single event." They do not describe all important single events that should be or may be investigated in greater detail by the facility. Each organization must determine which events warrant a formal root-cause analysis. This decision may be influenced by objective criteria such as those listed above, or may be left to the professional judgement of a committee responsible for reviewing all important single events. Regardless of how the decision is made, the process should be swift. A root-cause analysis should be initiated as rapidly as possible following a sentinel event. It’s important to quickly gather all the significant facts and the full spectrum of causal factors when they are still fresh in everyone’s memory.
• Define the root-cause analysis steps.
The goal of a root-cause analysis investigation is to identify the underlying factors that contributed to the event. If the root-cause analysis is seen as a routine quality improvement project, the investigation may not uncover these underlying factors. When an unwanted event occurs, too often teams only fix the symptoms or apparent causes of the event. Corrective actions can solve these proximate causes; but to prevent recurrence of the problem, the root causes must be identified and resolved.
In your organization’s sentinel event policy, be sure to describe the necessary components of a formal root-cause analysis. Many different root-cause analysis models have been developed in private industry to investigate accidents. The Joint Commission has also developed a root-cause analysis model. (See Joint Commission’s model on p. 185.) The only time a health care organization must follow the Joint Commission’s model is when it is placed on "Accreditation Watch." Regardless of the model adopted by the organization, it is important that the root-cause analysis of a sentinel event include the following components:
The analysis focuses primarily on the systems and processes underlying the apparent cause of the event.
The analysis repeatedly digs deeper to find the root causes of the event.
The analysis results in identification of system and/or process changes that will reduce the likelihood of sentinel events occurring in the future.
• Assign responsibilities.
Another element to be included in the organization’s sentinel event policy is assignment of responsibility for overseeing the root-cause analysis process. This may be a facilitator from the quality management department, or someone else with root-cause analysis training. This person also should be given the responsibility of preparing the summary of the completed root-cause analysis.
A question that commonly arises during discussion of a sentinel event policy is the role of a facility’s legal counsel. In some institutions, the organization’s attorney may be included as a member of the investigation team. Other facilities ask attorneys to provide advice, but they do not play an active role as investigation team members.
What committee will review the results of the root-cause analysis? This generally should be the organization’s Quality Council or similar leadership group. This committee will judge the completeness of the root-cause analysis and determine whether or not the corrective actions are reasonable. This committee should also be charged with evaluating the effectiveness of the action plans by reviewing post-implementation measurement data.
• Confidentiality issues.
The information collected during a sentinel event root-cause analysis can be very sensitive. The organization must determine how to protect the details from legal discovery in the case of malpractice litigation. In some states, protection can be ensured by maintaining all sentinel event investigations under the organization’s quality management/peer review process. In other states, better legal protection is afforded under the risk management program. Assurance of confidentiality is an important factor in a comprehensive root-cause analysis; therefore, it is critical that the process be conducted under the correct protective umbrella.
The management of a health care organization plays an important role in preventing sentinel events by creating a workplace free from patient care hazards. If an untoward event occurs, management also should have a defined procedure for effectively identifying and fixing the root causes of sentinel events. Root-cause analysis can be an effective management tool for discovering the true or actual causes of sentinel events, facilitating corrective action, and preventing the events’ recurrence. The root-cause analysis findings and proposed solutions ultimately will result in recommendations to management. If these recommendations are ignored or ineffectively implemented, or adequate resources not applied, then the root-cause analysis effort is doomed to eventual failure.
Reference
1. Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Hospitals (CAMH) Update 2. Oakbrook Terrace, IL: JCAHO; May 1997.
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