Sentinel Events and How to Learn From Them
Avery Tung, MD, FCCM Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL
Organizations involved in complex tasks have several ways to examine and improve the quality of their task performance. The most common approach is to assess how closely processes adhere to descriptors of ideal performance or match absolute or relative ideals. As an example, an industrial process involving inserting and tightening 2 screws can be evaluated by means of both process measures (the time required to attach and tighten the screws, variability in the time it takes, whether all screws are tightened to the same degree) and outcomes (how well the gear assembly works afterward and the breakdown rate of the gear assembly over time). Anesthesiologists are routinely involved in similarly complex care processes, in which both process measures (such as antibiotic timing) and outcome measures (such as postoperative reintubation) exist. A prerequisite to this approach to quality performance and work output is an assumption that the coupling between “ideal” task performance and outcome metrics is tight and easily identifiable. Clinical medical care, however, can introduce unpredictable variation into an already complex environment. Evolving care pathways, a high degree of complexity, unanticipated process changes, and diagnostic and therapeutic uncertainty may all cause clinical care to deviate from the expected. In addition, environmental constancy is not guaranteed. A process designed to optimize perioperative antibiotic delivery, for example, may suffer if new drug packaging increases the likelihood of a dangerous drug swap, if the process for identifying patient allergies is changed, or if epidemiological assumptions regarding perioperative pathogens change. The combination of high complexity, diagnostic/therapeutic uncertainty, and unanticipated environmental factors invites the possibility of an unexpected process or outcome failure. Importantly, such failures REPRINTS: AVERY TUNG, MD, FCCM, DEPARTMENT OF ANESTHESIA AND CRITICAL CARE, UNIVERSITY OF CHICAGO, 5841 S. MARYLAND AVE, MC 4028, CHICAGO, ILLINOIS 60637. E-MAIL: [email protected] INTERNATIONAL ANESTHESIOLOGY CLINICS Volume 52, Number 1, 53–68 r 2014, Lippincott Williams & Wilkins
www.anesthesiaclinics.com | 53
54
’
Tung
may not be detected using traditional process and outcome measures. An example in anesthesia practice might be a new workflow for documenting allergies on an electronic medical record, possibly predisposing to an allergic reaction in the operating room (OR). Such a failure would be invisible from perioperative antibiotic delivery metrics until the event actually occurs. Unexpected events of this type may be called “sentinel” if they involve serious harm or reveal a process flaw sufficiently large that the likelihood of a second, similar adverse event is high. In 1995, the Joint Commission (JC, a nongovernment US hospital–accrediting body) initiated a program requiring all accredited hospitals to report not only the occurrence of specific types of events but also the results of a focused review of the event.1 In doing so, the JC hoped that epidemiological and causative factors of specific events could be better understood, and that lessons learned would significantly improve the reliability, consistency, and performance of health care organizations. In anesthesiology, examining an unexpected failure can detect failure-prone task elements, uncover dangerous “work-arounds,” reveal changes in underlying assumptions about the process, and identify tasks in which greater or lesser protocolization may serve a role.2 This chapter will review the definition and key elements of a “sentinel event” as it relates to medicine, describe the JC sentinel event reporting system and the process of conducting a sentinel event analysis, examine relevant findings of the program, identify advantages and disadvantages of the sentinel event process, and discuss related approaches to detecting and addressing unexpected system failures.
’
Definition
Most sentinel event programs are nestled inside a larger adverse event–reporting system. Nearly all health systems worldwide run national reporting systems for clinical adverse events. In addition to the US JC program, organized structures for event reporting are present in (among others) England/Wales (National Reporting and Learning System; http://www.nrls.npsa.nhs.uk/), Denmark,3 Sweden,3,4 the Czech Republic,3 Japan,5 and Australia (http://www.anztadc.net/) (for a summary of other European reporting systems see European Commission3 and Commonwealth Fund5). Although slight variations in the types of events meriting special attention exist among these entities, most definitions incorporate 2 specific elements: that the event be unexpected (or unintended) and that the event has either caused harm or has the potential to do so. In this way, the definition includes both adverse events and near misses, provides flexibility for local variation with respect to the definition of harm, excludes malevolent behavior, www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
55
and does not require that an error or mistake occurred. An example of an adverse event not associated with medical error is an unexpected response to a drug. The specific term “sentinel event” derives from the US JC serious adverse event–reporting system and uses the word “sentinel” to designate events with a need for immediate investigation and response.6 To achieve JC accreditation, hospitals in the United States must maintain an in-house event-reporting system that identifies unexpected events that either cause serious harm or increase “the risk thereof.” The JC further designates 10 specific events (Table 1) that require that the hospital submit a specific report detailing the event, evidence that they have conducted a detailed “root cause” analysis, and an action plan resulting from that analysis.7 It is clear from Table 1 that decisions to cast some events (and not others) as “sentinel” and thus worthy of focused review reflect societal priorities and/or specific safety objectives, and that such lists may vary from one health care system to another. A system focused on provider error (such as the US JC) and designed to enforce accountability, for example, may create a list similar to Table 1. In contrast, other systems focused on new event detection and analysis (The Czech system, for example) may prioritize adverse events due to machine malfunction and/or drug side effects. Note that 4 of the 12 sentinel events requiring JC review are related in part to anesthesia practice, including unanticipated death/loss of function, transfusion reaction, wrong-side surgery or anesthesia, and unintended retained foreign object. The JC sentinel event policy also explicitly identifies specific events that do NOT require focused review and reporting. These are listed in Table 2. As with Table 1, specific items in Table 2 reflect JC preferences that may vary among health care systems. Note for example that unlike event-reporting systems in aviation,8 the JC policy excludes required reporting of near misses, and thus may not capture certain types of potential error. In addition, JC does not mandate adverse-event reporting, but rather expects that voluntary reporting will occur, and enforces that expectation with the threat of loss of accreditation. Other health care systems have similar structures to the US JC, but prioritize different events. Many do not have a specific “sentinel” designation. The Czech Republic requires mandatory reporting including nosocomial infections. The Danish health care system legally obligates health care providers to report specific events, and defines adverse events as “events resulting from treatment by or stay in a hospital and not from the illness of a patient. Adverse events shall comprise events and errors known and unknown.” Similar reporting systems exist in Japan and Sweden (for comparative review of health care reporting systems see World Health Organization9). www.anesthesiaclinics.com
56
’
Tung
Table 1. Sentinel Events Reviewable Per the Joint Commission Sentinel Event Policy7 Unanticipated death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition Suicide of any patient receiving care, treatment, and services in a staffed around-theclock care setting or within 72 h of discharge Unanticipated death of a full-term infant Abduction of any patient receiving care, treatment, and services Discharge of an infant to the wrong family Rape Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities Surgery on the wrong patient or wrong body part Unintended retention of a foreign object in a patient after surgery or other procedure Severe neonatal hyperbilirubinemia (bilirubin >30 mg/dL) Prolonged fluoroscopy with cumulative dose >1500 rads to a single field, or Any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose
Among reporting systems with a “serious” sentinel designation are those in England and Australia. In England, the National Reporting and Learning system requires reporting of patient safety incidents, and includes events distinctly different from those listed by the JC such as IT failures that threaten to prevent delivery of health care services, maternal death from postpartum hemorrhage after elective cesarean section, and avoidable death.10 Events designated as “serious” require notification of the Care Quality Commission and a focused root cause analysis (RCA). The Australian incident monitoring system also predefines specific events as “sentinel” and requires reporting of these events along with an RCA. As with other systems, definitions of sentinel events differ slightly; gas embolism leading to death or neurological damage is specifically highlighted as a sentinel event in the Australian system,11 for example, whereas the JC does not specify gas embolism in
Table 2. Sentinel Events Explicitly Not Requiring Focused Reporting and Review Per the Joint Commission7 Any near miss Any event fitting the description in Table 1 that does not affect a patient of the organization Medication errors that do not result in death or major permanent loss of function Full or expected return of limb or bodily function to the same level as before the adverse event by discharge or within 2 wk of the initial loss of said function, whichever is the longer period Minor hemolysis not caused by a major blood group incompatibility and with no clinical sequelae A death or loss of function after a patient leaving the organization against medical advice (AMA) www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
57
particular but would likely include such an event under the “unanticipated death or loss of function” category. Overall, reporting systems vary considerably from one health care system to another and may target learning (about new events or changes in the system), accountability (of caregivers), or both. Systems may be public or private. A general consensus exists that as many health care organizations as possible should participate, that the response to reported data is critical to progress, and that systematic changes to enhance safety be a potential goal. In the United States, the independent, nonprofit JC is responsible for accrediting hospitals and requires reporting and analysis of specific sentinel events as a precondition for successful accreditation. Primarily focused on accountability, the JC program has not only forced health care organizations to maintain a detection and reporting structure for adverse events, but also generated considerable data on relevant events in American health care.12,13
’
The Response to Sentinel Events: Root Cause Analysis
Most accountability systems that identify a type of event as “sentinel” require not only that the event be reported but also that a focused analysis take place. The JC specifically requires that the institution prepare and submit “a thorough and credible RCA and action plan within 45 calendar days of the known occurrence of the event.” JC staff then assess the review and action plan for appropriateness. The JC also requires that institutions that experience an (internally defined) sentinel event that does not appear on the list should report those events to the JC.7 An RCA uses a specific format to retrospectively analyze an adverse event. Rather than addressing all potential causative factors, RCA focuses on systems and processes (rather than individual performance) and strives to identify factors that underlie variation in performance. The general structure of such an analysis is to find causative elements specific to the process under question that are unrelated to human error, and identify potential improvements that can decrease the likelihood of similar events in the future. In the JC sentinel event program, RCA requires participation by organizational leaders and individuals most closely involved in the processes and systems, and multidisciplinary involvement. The explicit goal is to prevent recurrence, rather than assign blame, and to dig as deep as possible into identifying cause/effect linkages. Specific attention to both human and process/system factors as potential causative elements is mandatory, along with identification of high-risk processes and determination of potential improvements. www.anesthesiaclinics.com
58
’
Tung
Operationally, an RCA begins with data collection.14 This process requires defining as precisely as possible what happened, and also understanding the protocols and processes involved with the event. An analysis of an intraoperative transfusion error, for example, would include not only the intraoperative events and checking protocols, but also surgical blood ordering processes, communication between the OR and the blood bank, blood bank operations, transport, and storage processes (for an example of root cause analysis of a transfusion reaction see Elhence et al15). The next step in an RCA is causal factor charting. In this step, a diagram showing the chain of events is created, first in skeleton form, and then in progressively richer detail as more information is obtained. The diagram for the above-mentioned intraoperative transfusion error might look initially like Figure 1. Note that although such charts are read from left to right, they most commonly are created from right to left, starting with the event and using logic and time information to add and sequence relevant causal factors. Once the causes have been explored in as much depth as possible, root causes are then identified and tabulated. Where possible, recommendations for modifying or eliminating causal factors are made. Most root cause processes end with a summary table in which each root cause is identified, its relevance to the event under investigation noted, and formal recommendations listed. The root cause process need not involve implementation of recommended changes, although failure to implement changes renders that aspect of the root cause process less effective. ’
Real World Challenges in RCA
As can be seen from the description above, root cause analyses require a considerable amount of effort, time, and resources from investigators and practitioners. Existing evidence suggests that RCAs are often performed incompletely or incorrectly, focusing on a single cause
Figure 1. Example of a causal factor chart for a blood transfusion reaction. www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
59
for the event, failing to apply lessons from previous RCAs, or misunderstanding how actual clinical care is delivered.16 Observations of RCA processes suggest that compensating for hindsight bias and understanding the speech of clinicians involved in the event can be surprisingly difficult, and rules to modify causal factors are difficult to implement without constraining clinical practice.17 Since its inception in 1995, >9500 root cause analyses have been submitted to the JC.18 However, evidence that such analyses reduce adverse-event rates is surprisingly thin. In a 2006 external review of RCA, fewer than half of RCAs were judged appropriate.19 In another study of implementation, only 68% of cases reported fully implementing recommendations, with the majority being relatively weak “blame and train” strategies such as education or policy creation.20 Even when RCAs are performed appropriately, classifications of root causes may vary between reviewers. In one 2009 review of 300 event reports, agreement among experts with respect to root causes was moderate (k = 0.46), with poor to no agreement in 29% of reports.21 Lapsing into blame-oriented analysis can also impede root cause processes.17 Although the RCA process explicitly rejects the notion of “blame” in favor of systems analysis of adverse events, participants involved in the event may not be able to cognitively separate the 2 dimensions. Even if the process appears to focus on systems, a resulting recommendation to (for example) “educate anesthesiologists regarding transport policy” may be interpreted as blame. Moreover, in events resulting from multidisciplinary processes, individuals who must work together after the analysis is over may be loath to suggest causes that even indirectly implicate others. Finally, variability in medical judgment may prevent RCA analysts from clearly defining correct behavior. If, for example, the anesthesiologist argues that the cardiac surgeon should have been present for induction on a high-risk patient, but the surgeon disagrees that the patient was at high risk, what should the RCA conclude regarding surgeon presence on induction? Even when system-oriented solutions are developed that have a high likelihood of reducing event rates, implementing such solutions may not be possible with limited resources. Modifying epidural infusion systems to be incompatible with intravenous systems may evolve out of an RCA analysis of a drug swap error, but the cost of such a change may be prohibitive. JC statistics on sentinel events also suggest that RCAs are variably effective in preventing subsequent events. The number of reported events involving fatal falls, wrong-side surgery, and medical device injuries has increased between 1998 and 2012 despite sentinel event alerts (see below) and ongoing accreditation visits.22 Although JC reporting is voluntary, severe penalties for failing to report designated sentinel events (disaccreditation) provide a strong incentive to report www.anesthesiaclinics.com
60
’
Tung
events and increase the likelihood that trends are accurate reflections of event rates.
’
The JC Sentinel Event Alert System
Although individual hospital root cause analyses may have variable effectiveness, one potential advantage of centralized root cause reporting in the United States is the ability to collect sentinel events from throughout the country and analyze sentinel event data over time. This database has allowed the trending of specific events in response to alerts, and of unanticipated events that surface in the sentinel event database. These data are then disseminated back to hospitals in the form of sentinel event alerts for new events. In February of 1998, the JC released the first of a series of “Sentinel Event Alerts.”23,24 The report was based on >200 sentinel events reported over 2 years, and highlighted 10 deaths due to the direct administration of concentrated KCl. It further observed that in 6 of the 8 cases, KCl was mistaken for another medication, most often heparin, furosemide, or sodium chloride. On the basis of analysis of these reports, the JC recommended that concentrated KCl not be available outside the pharmacy unless appropriate safeguards are in place. This bulletin was eventually followed by a 2002 JC National Patient Safety goal to remove KCl from patient floors.25 A second alert followed 1 month later, notifying hospitals of a sentinel event hotline, and a third providing greater detail regarding the types of events deemed sentinel by JC criteria. To date, 50 Sentinel Event Alerts have been issued.26 Table 3 contains the topics of these alerts. Each bulletin provides basic numerical analysis derived from sentinel event reports submitted by hospitals, causative factors as identified by individual hospital RCA processes, and expert commentary regarding strategies for risk reduction. For anesthesiologists, Event Bulletin #12 assessed perioperative complications and was based on 64 cases.27 It excluded anesthesia administration errors, but identified several “most frequent complications” including NG/feeding tube insertion into the lung, fluid overload during genitourinary procedures, respiratory and cardiac arrest during orthopedic procedures, endoscopy with perforation of adjacent organs, arterial placement of a central line, and electrocautery-induced burns. In some cases, bulletins reference other databases of error events. Sentinel event bulletin #38, for example, focused on accidents during magnetic resonance imaging (MRI).28 Although only 5 MRI-related cases existed in the JC sentinel event database at the time of the alert (4 resulted in death), the bulletin referenced the FDA MAUDE (Manufacturer and User Facility Device Experience) database report. This database contained www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
Table 3.
’
61
Titles of Sentinel Event Alerts, 1998-201326
Deaths due to concentrated KCl Wrong-side surgery Inpatient suicide (2) Deaths due to restraints Infant abductions Blood transfusion errors High alert medications and patient safety Perioperative complications Fatal falls Infusion pumps Prospective risk analysis Fires in home care settings Kernicterus Look-alike, sound-alike drug names Creutzfeldt Jakob disease exposure through brain surgery tools Medical gas mixups Needlestick and sharps-related injuries Wrong-side surgery follow-up Ventilator-related deaths and injuries Delays in treatment Bed rail-related entrapment Infection control Surgical fires Infant death during delivery Anesthesia awareness Patient-controlled analgesia Vincristine administration errors Medication reconciliation Tubing misconnects Electrical power system failures Accidents in the MRI suite Pediatric medication errors Disruptive behavior Anticoagulant errors Health information technology Maternal death Violence in the health care setting Radiation risks of diagnostic imaging Health care worker fatigue and patient safety Safe use of opioids Medical device alarms MRI indicates magnetic resonance imaging.
389 MRI-related events, including pacemaker malfunctions, insulin pump failures, and projectiles. It is noteworthy that >70% of the reports were burns (most due to heating of metal cables during active scanning). Clearly, JC sentinel event bulletins highlight a wide diversity of adverse-event types. Specific areas of focus, however, are evident from the list in Table 3. Of the 50 bulletins, 8 (16%) focus on medication safety. An additional 11 (22%) address medical devices. Taken together, these www.anesthesiaclinics.com
62
’
Tung
bulletins provide a remarkable window into processes of clinical care in American hospitals, and a useful primer on current concepts in adverseevent prevention and what JC analysts consider critical safety concerns and their prevention. In 901 root cause submissions in 2012, 68% involved causes categorized by the JC as human factors, 62% involved leadership, and 59% involved communication29 (Table 4). These alerts have become widely accepted as accurate estimates of adverse events, spurring specialty society research into mechanisms of injury and prevention. The Foundation for Anesthesia Education and Research-funded BAG-RECALL project to study the effect of brain function monitoring on awareness during anesthesia, for example, was conceived in part as a response to Sentinel Alert #32 (awareness during anesthesia).30
’
Near Misses and Failure Modes Effects Analysis: Preventing Process-related Errors Before They Occur
Perhaps the biggest drawback to the sentinel event/RCA approach to unanticipated adverse events is its retrospective nature. Process flaws in care delivery are not apparent until the event actually occurs and a patient is harmed. To address this issue, health care organizations have developed 2 approaches to prospectively identifying processes at high risk for medical error. The first of these strategies is to include near misses as sentinel events. This approach is integral to the US Aviation Safety Reporting System, which encourages anonymous reporting of both adverse events and near misses. The JC database explicitly excludes near misses as events requiring review, but defines a sentinel event as “an unexpected occurrence involving death/serious injury or the risk thereof. ” Systems in other countries (see above) and even in individual states evaluate near misses on the same basis as actual events. In principle, by analyzing near misses, discovery of high-risk care processes can be identified before an adverse event occurs, allowing improvements to occur without sustaining an adverse event. However, considerable challenges exist in analysis of near-miss events. Few metrics exist to accurately define a near miss, and the appropriate ratio of near misses to actual events is unknown. Although near misses should be more common than actual adverse events, a 2012 survey of medication errors and near misses found 35 medication errors and 17 near misses in 8777 responses.31 This ratio differs considerably from the Pennsylvania Patient Safety Reporting System, in which >80% of reports are near misses.32 In a 2003 study of errors identified during routine ward care,33 near misses were defined as errors that did not result in patient harm, and incidences were 6.2% for adverse events and www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
Table 4.
’
63
Types of Root Causes as Identified by RCA Analysis in 201222
Human factors Staffing levels, staff skills, staff orientation, in-service, competency assessment, staff and resident supervision, medical staff credentialing/privileging, peer review, other (fatigue, distraction, complacency, bias) Leadership Organizational planning and culture, community relations, service availability, priority setting, resource allocation, complaint resolution, leadership collaboration, standardization, directing department/services, integration of services, inadequate policies and procedures, and/or noncompliance Communication Oral, written, electronic, with physicians, administrations, patient, or family RCA indicates root cause analysis.
4.2% for near misses. These data are consistent with the largest epidemiological study of errors to date,34 in which only a 3.7 incidence of adverse events were observed. In addition, evidence that analyzing near misses can affect actual event rates is unclear. Although advocated by the IOM 1999 report “To Err is Human,” only anecdotal evidence supports near-miss analysis. Examples of potential lives saved from the Pennsylvania Patient Safety Reporting System include sandbags containing metal pellets introduced into an MRI scanner and nonradioopaque sponges being used in OR procedures. An important challenge with near-miss reporting is that, as the event has yet to occur, baseline event rates may not exist to determine whether changes to care have reduced events. Nevertheless, advocates of near-miss reporting argue that the value of identifying high-risk processes before an adverse event occurs is self-evident. A second way to apply principles of RCA and sentinel event learning is to use a prospective technique adapted from the “failure mode and effect analysis” (FMEA) approach used in industry. Developed by the National Center for Patient Safety, this approach, termed “health care failure mode and effect analysis” or HFMEA strives to prospectively identify high-risk processes and improve their reliability and safety.35,36 Perhaps the best way to grasp the gist of HFMEA is to review the steps in such an approach (Fig. 2). Once the relevant process to be analyzed is identified, the next step is to identify a team with appropriate expertise and capable of critical review. Generally, both experts and nonexperts in the process are needed to appropriately review process issues. The process under review is then broken down into subprocesses, and the most vulnerable ones are identified. A hazard analysis is then performed. This step attempts to identify all the different ways that a particular process can fail. A process to identify and record patient allergies, for example, might fail if the interviewer is unable to accurately identify allergies, if the documentation form is difficult to read or www.anesthesiaclinics.com
64
’
Tung
Figure 2. Steps in health care failure mode and effect analysis.35,36
inaccessible, or if medications sound alike. In addition to imagination, the team should use all available sources to identify potential failures, including JC sentinel event alerts, Institute for Safe Medication Practices information, and FDA databases and advisories. Team members should next assign a severity score to each failure mode that reflects the impact on patient care if that failure were to occur, and a probability score that assesses how often such an event may occur. On the basis of high levels of probability and severity, processes are then selected for further evaluation. Failure modes are then assessed on the basis of criticality (whether the entire system will fail if this part fails), detectability (likelihood of detecting failure or the effect of failure before it occurs), and whether an effective control measure can meaningfully reduce the chance of failure. The process fix is then implemented and the resulting process tested to ensure that the system functions as predicted and that no new unanticipated vulnerabilities have been introduced. www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
65
It is easy to see that HFMEA is extremely time consuming. Because many separate processes and failure modes may be involved, it is nearly impossible to address every possible way the system can fail. In addition, process changes may not have their desired effect, either because the failure mode is poorly understood, or because unanticipated consequences may mitigate the potential benefit. Merely defining a process worthy of the intensive time commitment required by HFMEA analysis can be difficult. As an aid, the Institute of Heathcare Improvement keeps a repository of completed FMEA processes from different areas of health care (http://app.ihi.org/Workspace/tools/fmea/AllTools.aspx). Organizations interested in pursuing FMEA of a specific process can view the analyses of other organizations and generate their own FMEA on the basis of the original IHI example. Overall, because of the high workload, FMEA analyses should be reserved for high-volume, high-risk processes for which the risk of catastrophic failure is extremely high.
’
Summary
To improve, a process must not only compare its outcomes with established benchmarks, but also remain vigilant for subtle changes that can lead to catastrophic failures. Event reporting systems in general, and sentinel event reporting systems in particular, represent one strategy to allow complex processes to identify areas at high risk for causing unanticipated failures. By encouraging reporting of adverse events, participants in a process may not only provide useful feedback to others, but also trigger investigation targeted at eliminating high-risk workflow elements. Nearly every developed health care system in the world has some sort of event reporting system. These may be public or private in origin, voluntary or mandatory, and focus on new event detection or accountability for known catastrophic events. Many systems have identified specific or “sentinel” events deserving of special attention. Although lists of specific events requiring focused inquiry differ slightly from one system to another, all represent real, preventable harm to patients and carry the potential for significant improvements in patient safety. In the United States, the privately run JC operates a sentinel event reporting system that is focused on accountability, and identifies specific events worthy of reporting. Using fear of disaccreditation, the JC requires not only that specific events be reported, but also that a specific “root cause” analysis be performed. Such an analysis focuses on identifying and analyzing processes that may contribute to error, and www.anesthesiaclinics.com
66
’
Tung
systematically developing strategies to reduce the likelihood of error due to such high-risk processes. Evidence demonstrating that sentinel event reporting and RCA improves outcomes is rare. This surprising finding may result partly from the difficulty involved in correctly identifying root causes and fixing them. Studies suggest, for example, that the majority of corrective actions are “weak,” that is, policy and education based. Nevertheless, JC-designated sentinel events are so clearly harmful that any attempt to reduce their incidence has probable value. Perhaps the most important learning opportunity from the JC program derives from data on events reported to the JC over time. These data are released back to the public in the form of aggregate trends over time and specific information about events. Sentinel event bulletins, released by the JC, identify specific cases and the results of root causes performed elsewhere. Anesthesiologists have ample opportunity to improve care using sentinel event–type analyses. Although adverse events attributable to anesthesia practice are rare, anesthesiologists practice at the sharp end of extremely complex processes, and are in an ideal position to identify near misses, detect new drug events when they occur, and understand the root cause. Developing an event reporting system, building expertise in RCA, and continually identifying and improving weak spots in clinical care are likely to continue increasing the safety of clinical care.
The author declares that there is nothing to disclose.
’
References
1. O’Leary DS. The Sentinel Event Policy: a work in progress. Jt Comm Perspect. 1996; 16:2–3. 2. No authors listed. Sentinel events: approaches to error reduction and prevention. Jt Comm J Qual Improv. 1998;24:175–186. 3. European Commission. Health reporting systems at the national level. Available at: http://ec.europa.eu/health/reports/national/systems/index_en.htm. Accessed July 9, 2013. 4. Ohrn A, Elfstro ¨m J, Liedgren C, et al. Reporting of sentinel events in Swedish hospitals: a comparison of severe adverse events reported by patients and providers. Jt Comm J Qual Patient Saf. 2011;37:495–501. 5. Commonwealth Fund. International profiles of health care systems, 2012. Available at: http://www.commonwealthfund.org/˜/media/Files/Publications/Fund%20Report/ 2012/Nov/1645_Squires_intl_profiles_hlt_care_systems_2012.pdf. Accessed July 9, 2013. 6. Joint Commission. Sentinel event policy and procedures. Available at: http:// www.jointcommission.org/Sentinel_Event_Policy_and_Procedures/. Accessed February 9, 2013. www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
67
7. Joint Commission. Sentinel event policy statement, 2012. Available at: http:// www.jointcommission.org/assets/1/6/CAMH_2012_Update2_24_SE.pdf. Accessed February 9, 2013. 8. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from nonmedical near miss reporting systems. BMJ. 2000;320:759–763. 9. World Health Organization. World Health Organization guidelines for reporting systems, 2012. Available at: http://www.who.int/patientsafety/events/05/Reporting_ Guidelines.pdf. Accessed February 9, 2013. 10. Catchpole K, Bell MDD, Johnson S. Safety in anaesthesia: a study of 12 606 reported incidents from the UK National Reporting and Learning System. Anaesthesia. 2008;63:340–346. 11. Spigelman AD, Swan J. Review of the Australian incident monitoring system. ANZ J Surg. 2005;75:657–661. 12. Joint Commission. Sentinel event alert. Available at: http://www.jointcommission.org/ daily_update/joint_commission_daily_update.aspx?k = 721&b = &t = 4. Accessed February 9, 2013. 13. No authors listed. JCAHO initiates sentinel event alert. Am J Health Syst Pharm. 1998;55:764. 14. Rex JH, Turnbull JE, Allen SJ, et al. Systematic root cause analysis of adverse drug events in a tertiary referral hospital. Jt Comm J Qual Improv. 2000;26:563–575. 15. Elhence P, Veena S, Sharma RK, et al. Root cause analysis of transfusion error: identifying causes to implement changes. Transfusion. 2010;50:2772–2777. 16. Wu AW, Lipshutz AK, Pronovost PJ. Effectiveness and efficiency of root cause analysis in medicine. JAMA. 2008;299:685–687. 17. Iedema RA, Jorm C, Long D, et al. Turning the medical gaze in upon itself: root cause analysis and the investigation of clinical error. Soc Sci Med. 2006;62:1605–1615. 18. Joint Commission. Sentinel event data summary 1995-2012. Available at: http:// www.jointcommission.org/sentinel_event_statistics_quarterly/. Accessed May 9, 2013. 19. Wallace LM, Spurgeon P, Earll L. Evaluation of the NPSA’s 3 Day RCA Programme: Report to the Department of Health Patient Safety Research Programme. Coventry, UK: Coventry University; 2006. 20. Mills PD, Neily J, Luan D, et al. Actions and implementation strategies to reduce suicidal events in the Veterans Health Administration. Jt Comm J Qual Patient Saf. 2006;32:130–141. 21. Smits M, Janssen J, de Vet R, et al. Analysis of unintended events in hospitals: interrater reliability of constructing causal trees and classifying root causes. Int J Qual Health Care. 2009;21:292–300. 22. Joint Commission. Sentinel event data—event type by year. Available at: http:// www.jointcommission.org/sentinel_event.aspx. Accessed May 9, 2013. 23. Joint Commission. Sentinel event alert #1. Available at: http://www.jointcommission. org/sentinel_event_alert_issue_1_new_publication_/. Accessed May 9, 2013. 24. No authors listed. JCAHO initiates sentinel event alert. Am J Health Syst Pharm. 1998; 55:764. 25. Joint Commission. Facts about the National Patient Safety Goals. Available at: http:// www.jointcommission.org/facts_about_the_national_patient_safety_goals/. Accessed May 9, 2013. 26. Joint Commission. Sentinel event alert listing. Available at: http://www.jointcommission. org/daily_update/joint_commission_daily_update.aspx?k = 721&b = &t = 4. Accessed May 9, 2013. 27. Joint Commission. Sentinel event alert #12: operative and postoperative complications. Available at: http://www.jointcommission.org/sentinel_event_alert_issue_12_ operative_and_post-operative_complications_lessons_for_the_future/. Accessed July 9, 2013. www.anesthesiaclinics.com
68
’
Tung
28. Joint Commission. Sentinel event alert #38: preventing accidents and injuries in the MRI suite. Available at: http://www.jointcommission.org/sentinel_event_alert_ issue_38_preventing_accidents_and_injuries_in_the_mri_suite/. Accessed July 9, 2013. 29. Joint Commission. Sentinel event data—root causes by event type. Available at: http://www.jointcommission.org/Sentinel_Event_Statistics/. Accessed May 9, 2013. 30. Joint Commission. Sentinel event alert #32: preventing, and managing the impact of, anesthesia awareness. Available at: http://www.jointcommission.org/sentinel_event_ alert_issue_32_preventing_and_managing_the_impact_of_anesthesia_awareness/. Accessed July 9, 2013. 31. Cooper L, DiGiovanni N, Schultz L, et al. Influences observed on incidence and reporting of medication errors in anesthesia. Can J Anaesth. 2012;59:562–570. 32. Pennsylvania Patient Safety Authority. 2012 annual report. Available at: http:// patientsafetyauthority.org/PatientSafetyAuthority/Documents/Annual%20Report% 202012%20.pdf. Accessed May 9, 2013. 33. Chaudhry SI, Olofinboba KA, Krumholz HM. Detection of errors by attending physicians on a general medicine service. J Gen Intern Med. 2003;18:595–600. 34. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991; 324:377–384. 35. DeRosier J, Stalhandske E, Bagian JP, et al. Using health care failure mode and effect analysis: the VA National Center for Patient Safety’s prospective risk analysis system. Comm J Qual Improv. 2002;28:248–267; 209. 36. Ouellette-Piazzo K, Asfaw B, Cowen J. CT healthcare failure mode effect analysis (HFMEA): the misadministration of IV contrast in outpatients. Radiol Manage. 2007;29:36–44.
www.anesthesiaclinics.com
Avery Tung, MD, FCCM Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL
Organizations involved in complex tasks have several ways to examine and improve the quality of their task performance. The most common approach is to assess how closely processes adhere to descriptors of ideal performance or match absolute or relative ideals. As an example, an industrial process involving inserting and tightening 2 screws can be evaluated by means of both process measures (the time required to attach and tighten the screws, variability in the time it takes, whether all screws are tightened to the same degree) and outcomes (how well the gear assembly works afterward and the breakdown rate of the gear assembly over time). Anesthesiologists are routinely involved in similarly complex care processes, in which both process measures (such as antibiotic timing) and outcome measures (such as postoperative reintubation) exist. A prerequisite to this approach to quality performance and work output is an assumption that the coupling between “ideal” task performance and outcome metrics is tight and easily identifiable. Clinical medical care, however, can introduce unpredictable variation into an already complex environment. Evolving care pathways, a high degree of complexity, unanticipated process changes, and diagnostic and therapeutic uncertainty may all cause clinical care to deviate from the expected. In addition, environmental constancy is not guaranteed. A process designed to optimize perioperative antibiotic delivery, for example, may suffer if new drug packaging increases the likelihood of a dangerous drug swap, if the process for identifying patient allergies is changed, or if epidemiological assumptions regarding perioperative pathogens change. The combination of high complexity, diagnostic/therapeutic uncertainty, and unanticipated environmental factors invites the possibility of an unexpected process or outcome failure. Importantly, such failures REPRINTS: AVERY TUNG, MD, FCCM, DEPARTMENT OF ANESTHESIA AND CRITICAL CARE, UNIVERSITY OF CHICAGO, 5841 S. MARYLAND AVE, MC 4028, CHICAGO, ILLINOIS 60637. E-MAIL: [email protected] INTERNATIONAL ANESTHESIOLOGY CLINICS Volume 52, Number 1, 53–68 r 2014, Lippincott Williams & Wilkins
www.anesthesiaclinics.com | 53
54
’
Tung
may not be detected using traditional process and outcome measures. An example in anesthesia practice might be a new workflow for documenting allergies on an electronic medical record, possibly predisposing to an allergic reaction in the operating room (OR). Such a failure would be invisible from perioperative antibiotic delivery metrics until the event actually occurs. Unexpected events of this type may be called “sentinel” if they involve serious harm or reveal a process flaw sufficiently large that the likelihood of a second, similar adverse event is high. In 1995, the Joint Commission (JC, a nongovernment US hospital–accrediting body) initiated a program requiring all accredited hospitals to report not only the occurrence of specific types of events but also the results of a focused review of the event.1 In doing so, the JC hoped that epidemiological and causative factors of specific events could be better understood, and that lessons learned would significantly improve the reliability, consistency, and performance of health care organizations. In anesthesiology, examining an unexpected failure can detect failure-prone task elements, uncover dangerous “work-arounds,” reveal changes in underlying assumptions about the process, and identify tasks in which greater or lesser protocolization may serve a role.2 This chapter will review the definition and key elements of a “sentinel event” as it relates to medicine, describe the JC sentinel event reporting system and the process of conducting a sentinel event analysis, examine relevant findings of the program, identify advantages and disadvantages of the sentinel event process, and discuss related approaches to detecting and addressing unexpected system failures.
’
Definition
Most sentinel event programs are nestled inside a larger adverse event–reporting system. Nearly all health systems worldwide run national reporting systems for clinical adverse events. In addition to the US JC program, organized structures for event reporting are present in (among others) England/Wales (National Reporting and Learning System; http://www.nrls.npsa.nhs.uk/), Denmark,3 Sweden,3,4 the Czech Republic,3 Japan,5 and Australia (http://www.anztadc.net/) (for a summary of other European reporting systems see European Commission3 and Commonwealth Fund5). Although slight variations in the types of events meriting special attention exist among these entities, most definitions incorporate 2 specific elements: that the event be unexpected (or unintended) and that the event has either caused harm or has the potential to do so. In this way, the definition includes both adverse events and near misses, provides flexibility for local variation with respect to the definition of harm, excludes malevolent behavior, www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
55
and does not require that an error or mistake occurred. An example of an adverse event not associated with medical error is an unexpected response to a drug. The specific term “sentinel event” derives from the US JC serious adverse event–reporting system and uses the word “sentinel” to designate events with a need for immediate investigation and response.6 To achieve JC accreditation, hospitals in the United States must maintain an in-house event-reporting system that identifies unexpected events that either cause serious harm or increase “the risk thereof.” The JC further designates 10 specific events (Table 1) that require that the hospital submit a specific report detailing the event, evidence that they have conducted a detailed “root cause” analysis, and an action plan resulting from that analysis.7 It is clear from Table 1 that decisions to cast some events (and not others) as “sentinel” and thus worthy of focused review reflect societal priorities and/or specific safety objectives, and that such lists may vary from one health care system to another. A system focused on provider error (such as the US JC) and designed to enforce accountability, for example, may create a list similar to Table 1. In contrast, other systems focused on new event detection and analysis (The Czech system, for example) may prioritize adverse events due to machine malfunction and/or drug side effects. Note that 4 of the 12 sentinel events requiring JC review are related in part to anesthesia practice, including unanticipated death/loss of function, transfusion reaction, wrong-side surgery or anesthesia, and unintended retained foreign object. The JC sentinel event policy also explicitly identifies specific events that do NOT require focused review and reporting. These are listed in Table 2. As with Table 1, specific items in Table 2 reflect JC preferences that may vary among health care systems. Note for example that unlike event-reporting systems in aviation,8 the JC policy excludes required reporting of near misses, and thus may not capture certain types of potential error. In addition, JC does not mandate adverse-event reporting, but rather expects that voluntary reporting will occur, and enforces that expectation with the threat of loss of accreditation. Other health care systems have similar structures to the US JC, but prioritize different events. Many do not have a specific “sentinel” designation. The Czech Republic requires mandatory reporting including nosocomial infections. The Danish health care system legally obligates health care providers to report specific events, and defines adverse events as “events resulting from treatment by or stay in a hospital and not from the illness of a patient. Adverse events shall comprise events and errors known and unknown.” Similar reporting systems exist in Japan and Sweden (for comparative review of health care reporting systems see World Health Organization9). www.anesthesiaclinics.com
56
’
Tung
Table 1. Sentinel Events Reviewable Per the Joint Commission Sentinel Event Policy7 Unanticipated death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition Suicide of any patient receiving care, treatment, and services in a staffed around-theclock care setting or within 72 h of discharge Unanticipated death of a full-term infant Abduction of any patient receiving care, treatment, and services Discharge of an infant to the wrong family Rape Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities Surgery on the wrong patient or wrong body part Unintended retention of a foreign object in a patient after surgery or other procedure Severe neonatal hyperbilirubinemia (bilirubin >30 mg/dL) Prolonged fluoroscopy with cumulative dose >1500 rads to a single field, or Any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose
Among reporting systems with a “serious” sentinel designation are those in England and Australia. In England, the National Reporting and Learning system requires reporting of patient safety incidents, and includes events distinctly different from those listed by the JC such as IT failures that threaten to prevent delivery of health care services, maternal death from postpartum hemorrhage after elective cesarean section, and avoidable death.10 Events designated as “serious” require notification of the Care Quality Commission and a focused root cause analysis (RCA). The Australian incident monitoring system also predefines specific events as “sentinel” and requires reporting of these events along with an RCA. As with other systems, definitions of sentinel events differ slightly; gas embolism leading to death or neurological damage is specifically highlighted as a sentinel event in the Australian system,11 for example, whereas the JC does not specify gas embolism in
Table 2. Sentinel Events Explicitly Not Requiring Focused Reporting and Review Per the Joint Commission7 Any near miss Any event fitting the description in Table 1 that does not affect a patient of the organization Medication errors that do not result in death or major permanent loss of function Full or expected return of limb or bodily function to the same level as before the adverse event by discharge or within 2 wk of the initial loss of said function, whichever is the longer period Minor hemolysis not caused by a major blood group incompatibility and with no clinical sequelae A death or loss of function after a patient leaving the organization against medical advice (AMA) www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
57
particular but would likely include such an event under the “unanticipated death or loss of function” category. Overall, reporting systems vary considerably from one health care system to another and may target learning (about new events or changes in the system), accountability (of caregivers), or both. Systems may be public or private. A general consensus exists that as many health care organizations as possible should participate, that the response to reported data is critical to progress, and that systematic changes to enhance safety be a potential goal. In the United States, the independent, nonprofit JC is responsible for accrediting hospitals and requires reporting and analysis of specific sentinel events as a precondition for successful accreditation. Primarily focused on accountability, the JC program has not only forced health care organizations to maintain a detection and reporting structure for adverse events, but also generated considerable data on relevant events in American health care.12,13
’
The Response to Sentinel Events: Root Cause Analysis
Most accountability systems that identify a type of event as “sentinel” require not only that the event be reported but also that a focused analysis take place. The JC specifically requires that the institution prepare and submit “a thorough and credible RCA and action plan within 45 calendar days of the known occurrence of the event.” JC staff then assess the review and action plan for appropriateness. The JC also requires that institutions that experience an (internally defined) sentinel event that does not appear on the list should report those events to the JC.7 An RCA uses a specific format to retrospectively analyze an adverse event. Rather than addressing all potential causative factors, RCA focuses on systems and processes (rather than individual performance) and strives to identify factors that underlie variation in performance. The general structure of such an analysis is to find causative elements specific to the process under question that are unrelated to human error, and identify potential improvements that can decrease the likelihood of similar events in the future. In the JC sentinel event program, RCA requires participation by organizational leaders and individuals most closely involved in the processes and systems, and multidisciplinary involvement. The explicit goal is to prevent recurrence, rather than assign blame, and to dig as deep as possible into identifying cause/effect linkages. Specific attention to both human and process/system factors as potential causative elements is mandatory, along with identification of high-risk processes and determination of potential improvements. www.anesthesiaclinics.com
58
’
Tung
Operationally, an RCA begins with data collection.14 This process requires defining as precisely as possible what happened, and also understanding the protocols and processes involved with the event. An analysis of an intraoperative transfusion error, for example, would include not only the intraoperative events and checking protocols, but also surgical blood ordering processes, communication between the OR and the blood bank, blood bank operations, transport, and storage processes (for an example of root cause analysis of a transfusion reaction see Elhence et al15). The next step in an RCA is causal factor charting. In this step, a diagram showing the chain of events is created, first in skeleton form, and then in progressively richer detail as more information is obtained. The diagram for the above-mentioned intraoperative transfusion error might look initially like Figure 1. Note that although such charts are read from left to right, they most commonly are created from right to left, starting with the event and using logic and time information to add and sequence relevant causal factors. Once the causes have been explored in as much depth as possible, root causes are then identified and tabulated. Where possible, recommendations for modifying or eliminating causal factors are made. Most root cause processes end with a summary table in which each root cause is identified, its relevance to the event under investigation noted, and formal recommendations listed. The root cause process need not involve implementation of recommended changes, although failure to implement changes renders that aspect of the root cause process less effective. ’
Real World Challenges in RCA
As can be seen from the description above, root cause analyses require a considerable amount of effort, time, and resources from investigators and practitioners. Existing evidence suggests that RCAs are often performed incompletely or incorrectly, focusing on a single cause
Figure 1. Example of a causal factor chart for a blood transfusion reaction. www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
59
for the event, failing to apply lessons from previous RCAs, or misunderstanding how actual clinical care is delivered.16 Observations of RCA processes suggest that compensating for hindsight bias and understanding the speech of clinicians involved in the event can be surprisingly difficult, and rules to modify causal factors are difficult to implement without constraining clinical practice.17 Since its inception in 1995, >9500 root cause analyses have been submitted to the JC.18 However, evidence that such analyses reduce adverse-event rates is surprisingly thin. In a 2006 external review of RCA, fewer than half of RCAs were judged appropriate.19 In another study of implementation, only 68% of cases reported fully implementing recommendations, with the majority being relatively weak “blame and train” strategies such as education or policy creation.20 Even when RCAs are performed appropriately, classifications of root causes may vary between reviewers. In one 2009 review of 300 event reports, agreement among experts with respect to root causes was moderate (k = 0.46), with poor to no agreement in 29% of reports.21 Lapsing into blame-oriented analysis can also impede root cause processes.17 Although the RCA process explicitly rejects the notion of “blame” in favor of systems analysis of adverse events, participants involved in the event may not be able to cognitively separate the 2 dimensions. Even if the process appears to focus on systems, a resulting recommendation to (for example) “educate anesthesiologists regarding transport policy” may be interpreted as blame. Moreover, in events resulting from multidisciplinary processes, individuals who must work together after the analysis is over may be loath to suggest causes that even indirectly implicate others. Finally, variability in medical judgment may prevent RCA analysts from clearly defining correct behavior. If, for example, the anesthesiologist argues that the cardiac surgeon should have been present for induction on a high-risk patient, but the surgeon disagrees that the patient was at high risk, what should the RCA conclude regarding surgeon presence on induction? Even when system-oriented solutions are developed that have a high likelihood of reducing event rates, implementing such solutions may not be possible with limited resources. Modifying epidural infusion systems to be incompatible with intravenous systems may evolve out of an RCA analysis of a drug swap error, but the cost of such a change may be prohibitive. JC statistics on sentinel events also suggest that RCAs are variably effective in preventing subsequent events. The number of reported events involving fatal falls, wrong-side surgery, and medical device injuries has increased between 1998 and 2012 despite sentinel event alerts (see below) and ongoing accreditation visits.22 Although JC reporting is voluntary, severe penalties for failing to report designated sentinel events (disaccreditation) provide a strong incentive to report www.anesthesiaclinics.com
60
’
Tung
events and increase the likelihood that trends are accurate reflections of event rates.
’
The JC Sentinel Event Alert System
Although individual hospital root cause analyses may have variable effectiveness, one potential advantage of centralized root cause reporting in the United States is the ability to collect sentinel events from throughout the country and analyze sentinel event data over time. This database has allowed the trending of specific events in response to alerts, and of unanticipated events that surface in the sentinel event database. These data are then disseminated back to hospitals in the form of sentinel event alerts for new events. In February of 1998, the JC released the first of a series of “Sentinel Event Alerts.”23,24 The report was based on >200 sentinel events reported over 2 years, and highlighted 10 deaths due to the direct administration of concentrated KCl. It further observed that in 6 of the 8 cases, KCl was mistaken for another medication, most often heparin, furosemide, or sodium chloride. On the basis of analysis of these reports, the JC recommended that concentrated KCl not be available outside the pharmacy unless appropriate safeguards are in place. This bulletin was eventually followed by a 2002 JC National Patient Safety goal to remove KCl from patient floors.25 A second alert followed 1 month later, notifying hospitals of a sentinel event hotline, and a third providing greater detail regarding the types of events deemed sentinel by JC criteria. To date, 50 Sentinel Event Alerts have been issued.26 Table 3 contains the topics of these alerts. Each bulletin provides basic numerical analysis derived from sentinel event reports submitted by hospitals, causative factors as identified by individual hospital RCA processes, and expert commentary regarding strategies for risk reduction. For anesthesiologists, Event Bulletin #12 assessed perioperative complications and was based on 64 cases.27 It excluded anesthesia administration errors, but identified several “most frequent complications” including NG/feeding tube insertion into the lung, fluid overload during genitourinary procedures, respiratory and cardiac arrest during orthopedic procedures, endoscopy with perforation of adjacent organs, arterial placement of a central line, and electrocautery-induced burns. In some cases, bulletins reference other databases of error events. Sentinel event bulletin #38, for example, focused on accidents during magnetic resonance imaging (MRI).28 Although only 5 MRI-related cases existed in the JC sentinel event database at the time of the alert (4 resulted in death), the bulletin referenced the FDA MAUDE (Manufacturer and User Facility Device Experience) database report. This database contained www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
Table 3.
’
61
Titles of Sentinel Event Alerts, 1998-201326
Deaths due to concentrated KCl Wrong-side surgery Inpatient suicide (2) Deaths due to restraints Infant abductions Blood transfusion errors High alert medications and patient safety Perioperative complications Fatal falls Infusion pumps Prospective risk analysis Fires in home care settings Kernicterus Look-alike, sound-alike drug names Creutzfeldt Jakob disease exposure through brain surgery tools Medical gas mixups Needlestick and sharps-related injuries Wrong-side surgery follow-up Ventilator-related deaths and injuries Delays in treatment Bed rail-related entrapment Infection control Surgical fires Infant death during delivery Anesthesia awareness Patient-controlled analgesia Vincristine administration errors Medication reconciliation Tubing misconnects Electrical power system failures Accidents in the MRI suite Pediatric medication errors Disruptive behavior Anticoagulant errors Health information technology Maternal death Violence in the health care setting Radiation risks of diagnostic imaging Health care worker fatigue and patient safety Safe use of opioids Medical device alarms MRI indicates magnetic resonance imaging.
389 MRI-related events, including pacemaker malfunctions, insulin pump failures, and projectiles. It is noteworthy that >70% of the reports were burns (most due to heating of metal cables during active scanning). Clearly, JC sentinel event bulletins highlight a wide diversity of adverse-event types. Specific areas of focus, however, are evident from the list in Table 3. Of the 50 bulletins, 8 (16%) focus on medication safety. An additional 11 (22%) address medical devices. Taken together, these www.anesthesiaclinics.com
62
’
Tung
bulletins provide a remarkable window into processes of clinical care in American hospitals, and a useful primer on current concepts in adverseevent prevention and what JC analysts consider critical safety concerns and their prevention. In 901 root cause submissions in 2012, 68% involved causes categorized by the JC as human factors, 62% involved leadership, and 59% involved communication29 (Table 4). These alerts have become widely accepted as accurate estimates of adverse events, spurring specialty society research into mechanisms of injury and prevention. The Foundation for Anesthesia Education and Research-funded BAG-RECALL project to study the effect of brain function monitoring on awareness during anesthesia, for example, was conceived in part as a response to Sentinel Alert #32 (awareness during anesthesia).30
’
Near Misses and Failure Modes Effects Analysis: Preventing Process-related Errors Before They Occur
Perhaps the biggest drawback to the sentinel event/RCA approach to unanticipated adverse events is its retrospective nature. Process flaws in care delivery are not apparent until the event actually occurs and a patient is harmed. To address this issue, health care organizations have developed 2 approaches to prospectively identifying processes at high risk for medical error. The first of these strategies is to include near misses as sentinel events. This approach is integral to the US Aviation Safety Reporting System, which encourages anonymous reporting of both adverse events and near misses. The JC database explicitly excludes near misses as events requiring review, but defines a sentinel event as “an unexpected occurrence involving death/serious injury or the risk thereof. ” Systems in other countries (see above) and even in individual states evaluate near misses on the same basis as actual events. In principle, by analyzing near misses, discovery of high-risk care processes can be identified before an adverse event occurs, allowing improvements to occur without sustaining an adverse event. However, considerable challenges exist in analysis of near-miss events. Few metrics exist to accurately define a near miss, and the appropriate ratio of near misses to actual events is unknown. Although near misses should be more common than actual adverse events, a 2012 survey of medication errors and near misses found 35 medication errors and 17 near misses in 8777 responses.31 This ratio differs considerably from the Pennsylvania Patient Safety Reporting System, in which >80% of reports are near misses.32 In a 2003 study of errors identified during routine ward care,33 near misses were defined as errors that did not result in patient harm, and incidences were 6.2% for adverse events and www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
Table 4.
’
63
Types of Root Causes as Identified by RCA Analysis in 201222
Human factors Staffing levels, staff skills, staff orientation, in-service, competency assessment, staff and resident supervision, medical staff credentialing/privileging, peer review, other (fatigue, distraction, complacency, bias) Leadership Organizational planning and culture, community relations, service availability, priority setting, resource allocation, complaint resolution, leadership collaboration, standardization, directing department/services, integration of services, inadequate policies and procedures, and/or noncompliance Communication Oral, written, electronic, with physicians, administrations, patient, or family RCA indicates root cause analysis.
4.2% for near misses. These data are consistent with the largest epidemiological study of errors to date,34 in which only a 3.7 incidence of adverse events were observed. In addition, evidence that analyzing near misses can affect actual event rates is unclear. Although advocated by the IOM 1999 report “To Err is Human,” only anecdotal evidence supports near-miss analysis. Examples of potential lives saved from the Pennsylvania Patient Safety Reporting System include sandbags containing metal pellets introduced into an MRI scanner and nonradioopaque sponges being used in OR procedures. An important challenge with near-miss reporting is that, as the event has yet to occur, baseline event rates may not exist to determine whether changes to care have reduced events. Nevertheless, advocates of near-miss reporting argue that the value of identifying high-risk processes before an adverse event occurs is self-evident. A second way to apply principles of RCA and sentinel event learning is to use a prospective technique adapted from the “failure mode and effect analysis” (FMEA) approach used in industry. Developed by the National Center for Patient Safety, this approach, termed “health care failure mode and effect analysis” or HFMEA strives to prospectively identify high-risk processes and improve their reliability and safety.35,36 Perhaps the best way to grasp the gist of HFMEA is to review the steps in such an approach (Fig. 2). Once the relevant process to be analyzed is identified, the next step is to identify a team with appropriate expertise and capable of critical review. Generally, both experts and nonexperts in the process are needed to appropriately review process issues. The process under review is then broken down into subprocesses, and the most vulnerable ones are identified. A hazard analysis is then performed. This step attempts to identify all the different ways that a particular process can fail. A process to identify and record patient allergies, for example, might fail if the interviewer is unable to accurately identify allergies, if the documentation form is difficult to read or www.anesthesiaclinics.com
64
’
Tung
Figure 2. Steps in health care failure mode and effect analysis.35,36
inaccessible, or if medications sound alike. In addition to imagination, the team should use all available sources to identify potential failures, including JC sentinel event alerts, Institute for Safe Medication Practices information, and FDA databases and advisories. Team members should next assign a severity score to each failure mode that reflects the impact on patient care if that failure were to occur, and a probability score that assesses how often such an event may occur. On the basis of high levels of probability and severity, processes are then selected for further evaluation. Failure modes are then assessed on the basis of criticality (whether the entire system will fail if this part fails), detectability (likelihood of detecting failure or the effect of failure before it occurs), and whether an effective control measure can meaningfully reduce the chance of failure. The process fix is then implemented and the resulting process tested to ensure that the system functions as predicted and that no new unanticipated vulnerabilities have been introduced. www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
65
It is easy to see that HFMEA is extremely time consuming. Because many separate processes and failure modes may be involved, it is nearly impossible to address every possible way the system can fail. In addition, process changes may not have their desired effect, either because the failure mode is poorly understood, or because unanticipated consequences may mitigate the potential benefit. Merely defining a process worthy of the intensive time commitment required by HFMEA analysis can be difficult. As an aid, the Institute of Heathcare Improvement keeps a repository of completed FMEA processes from different areas of health care (http://app.ihi.org/Workspace/tools/fmea/AllTools.aspx). Organizations interested in pursuing FMEA of a specific process can view the analyses of other organizations and generate their own FMEA on the basis of the original IHI example. Overall, because of the high workload, FMEA analyses should be reserved for high-volume, high-risk processes for which the risk of catastrophic failure is extremely high.
’
Summary
To improve, a process must not only compare its outcomes with established benchmarks, but also remain vigilant for subtle changes that can lead to catastrophic failures. Event reporting systems in general, and sentinel event reporting systems in particular, represent one strategy to allow complex processes to identify areas at high risk for causing unanticipated failures. By encouraging reporting of adverse events, participants in a process may not only provide useful feedback to others, but also trigger investigation targeted at eliminating high-risk workflow elements. Nearly every developed health care system in the world has some sort of event reporting system. These may be public or private in origin, voluntary or mandatory, and focus on new event detection or accountability for known catastrophic events. Many systems have identified specific or “sentinel” events deserving of special attention. Although lists of specific events requiring focused inquiry differ slightly from one system to another, all represent real, preventable harm to patients and carry the potential for significant improvements in patient safety. In the United States, the privately run JC operates a sentinel event reporting system that is focused on accountability, and identifies specific events worthy of reporting. Using fear of disaccreditation, the JC requires not only that specific events be reported, but also that a specific “root cause” analysis be performed. Such an analysis focuses on identifying and analyzing processes that may contribute to error, and www.anesthesiaclinics.com
66
’
Tung
systematically developing strategies to reduce the likelihood of error due to such high-risk processes. Evidence demonstrating that sentinel event reporting and RCA improves outcomes is rare. This surprising finding may result partly from the difficulty involved in correctly identifying root causes and fixing them. Studies suggest, for example, that the majority of corrective actions are “weak,” that is, policy and education based. Nevertheless, JC-designated sentinel events are so clearly harmful that any attempt to reduce their incidence has probable value. Perhaps the most important learning opportunity from the JC program derives from data on events reported to the JC over time. These data are released back to the public in the form of aggregate trends over time and specific information about events. Sentinel event bulletins, released by the JC, identify specific cases and the results of root causes performed elsewhere. Anesthesiologists have ample opportunity to improve care using sentinel event–type analyses. Although adverse events attributable to anesthesia practice are rare, anesthesiologists practice at the sharp end of extremely complex processes, and are in an ideal position to identify near misses, detect new drug events when they occur, and understand the root cause. Developing an event reporting system, building expertise in RCA, and continually identifying and improving weak spots in clinical care are likely to continue increasing the safety of clinical care.
The author declares that there is nothing to disclose.
’
References
1. O’Leary DS. The Sentinel Event Policy: a work in progress. Jt Comm Perspect. 1996; 16:2–3. 2. No authors listed. Sentinel events: approaches to error reduction and prevention. Jt Comm J Qual Improv. 1998;24:175–186. 3. European Commission. Health reporting systems at the national level. Available at: http://ec.europa.eu/health/reports/national/systems/index_en.htm. Accessed July 9, 2013. 4. Ohrn A, Elfstro ¨m J, Liedgren C, et al. Reporting of sentinel events in Swedish hospitals: a comparison of severe adverse events reported by patients and providers. Jt Comm J Qual Patient Saf. 2011;37:495–501. 5. Commonwealth Fund. International profiles of health care systems, 2012. Available at: http://www.commonwealthfund.org/˜/media/Files/Publications/Fund%20Report/ 2012/Nov/1645_Squires_intl_profiles_hlt_care_systems_2012.pdf. Accessed July 9, 2013. 6. Joint Commission. Sentinel event policy and procedures. Available at: http:// www.jointcommission.org/Sentinel_Event_Policy_and_Procedures/. Accessed February 9, 2013. www.anesthesiaclinics.com
Sentinel Events and How to Learn From Them
’
67
7. Joint Commission. Sentinel event policy statement, 2012. Available at: http:// www.jointcommission.org/assets/1/6/CAMH_2012_Update2_24_SE.pdf. Accessed February 9, 2013. 8. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from nonmedical near miss reporting systems. BMJ. 2000;320:759–763. 9. World Health Organization. World Health Organization guidelines for reporting systems, 2012. Available at: http://www.who.int/patientsafety/events/05/Reporting_ Guidelines.pdf. Accessed February 9, 2013. 10. Catchpole K, Bell MDD, Johnson S. Safety in anaesthesia: a study of 12 606 reported incidents from the UK National Reporting and Learning System. Anaesthesia. 2008;63:340–346. 11. Spigelman AD, Swan J. Review of the Australian incident monitoring system. ANZ J Surg. 2005;75:657–661. 12. Joint Commission. Sentinel event alert. Available at: http://www.jointcommission.org/ daily_update/joint_commission_daily_update.aspx?k = 721&b = &t = 4. Accessed February 9, 2013. 13. No authors listed. JCAHO initiates sentinel event alert. Am J Health Syst Pharm. 1998;55:764. 14. Rex JH, Turnbull JE, Allen SJ, et al. Systematic root cause analysis of adverse drug events in a tertiary referral hospital. Jt Comm J Qual Improv. 2000;26:563–575. 15. Elhence P, Veena S, Sharma RK, et al. Root cause analysis of transfusion error: identifying causes to implement changes. Transfusion. 2010;50:2772–2777. 16. Wu AW, Lipshutz AK, Pronovost PJ. Effectiveness and efficiency of root cause analysis in medicine. JAMA. 2008;299:685–687. 17. Iedema RA, Jorm C, Long D, et al. Turning the medical gaze in upon itself: root cause analysis and the investigation of clinical error. Soc Sci Med. 2006;62:1605–1615. 18. Joint Commission. Sentinel event data summary 1995-2012. Available at: http:// www.jointcommission.org/sentinel_event_statistics_quarterly/. Accessed May 9, 2013. 19. Wallace LM, Spurgeon P, Earll L. Evaluation of the NPSA’s 3 Day RCA Programme: Report to the Department of Health Patient Safety Research Programme. Coventry, UK: Coventry University; 2006. 20. Mills PD, Neily J, Luan D, et al. Actions and implementation strategies to reduce suicidal events in the Veterans Health Administration. Jt Comm J Qual Patient Saf. 2006;32:130–141. 21. Smits M, Janssen J, de Vet R, et al. Analysis of unintended events in hospitals: interrater reliability of constructing causal trees and classifying root causes. Int J Qual Health Care. 2009;21:292–300. 22. Joint Commission. Sentinel event data—event type by year. Available at: http:// www.jointcommission.org/sentinel_event.aspx. Accessed May 9, 2013. 23. Joint Commission. Sentinel event alert #1. Available at: http://www.jointcommission. org/sentinel_event_alert_issue_1_new_publication_/. Accessed May 9, 2013. 24. No authors listed. JCAHO initiates sentinel event alert. Am J Health Syst Pharm. 1998; 55:764. 25. Joint Commission. Facts about the National Patient Safety Goals. Available at: http:// www.jointcommission.org/facts_about_the_national_patient_safety_goals/. Accessed May 9, 2013. 26. Joint Commission. Sentinel event alert listing. Available at: http://www.jointcommission. org/daily_update/joint_commission_daily_update.aspx?k = 721&b = &t = 4. Accessed May 9, 2013. 27. Joint Commission. Sentinel event alert #12: operative and postoperative complications. Available at: http://www.jointcommission.org/sentinel_event_alert_issue_12_ operative_and_post-operative_complications_lessons_for_the_future/. Accessed July 9, 2013. www.anesthesiaclinics.com
68
’
Tung
28. Joint Commission. Sentinel event alert #38: preventing accidents and injuries in the MRI suite. Available at: http://www.jointcommission.org/sentinel_event_alert_ issue_38_preventing_accidents_and_injuries_in_the_mri_suite/. Accessed July 9, 2013. 29. Joint Commission. Sentinel event data—root causes by event type. Available at: http://www.jointcommission.org/Sentinel_Event_Statistics/. Accessed May 9, 2013. 30. Joint Commission. Sentinel event alert #32: preventing, and managing the impact of, anesthesia awareness. Available at: http://www.jointcommission.org/sentinel_event_ alert_issue_32_preventing_and_managing_the_impact_of_anesthesia_awareness/. Accessed July 9, 2013. 31. Cooper L, DiGiovanni N, Schultz L, et al. Influences observed on incidence and reporting of medication errors in anesthesia. Can J Anaesth. 2012;59:562–570. 32. Pennsylvania Patient Safety Authority. 2012 annual report. Available at: http:// patientsafetyauthority.org/PatientSafetyAuthority/Documents/Annual%20Report% 202012%20.pdf. Accessed May 9, 2013. 33. Chaudhry SI, Olofinboba KA, Krumholz HM. Detection of errors by attending physicians on a general medicine service. J Gen Intern Med. 2003;18:595–600. 34. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991; 324:377–384. 35. DeRosier J, Stalhandske E, Bagian JP, et al. Using health care failure mode and effect analysis: the VA National Center for Patient Safety’s prospective risk analysis system. Comm J Qual Improv. 2002;28:248–267; 209. 36. Ouellette-Piazzo K, Asfaw B, Cowen J. CT healthcare failure mode effect analysis (HFMEA): the misadministration of IV contrast in outpatients. Radiol Manage. 2007;29:36–44.
www.anesthesiaclinics.com
