Incident Reporting at the Local and National Level
Patrick J. Guffey, MD Department of Anesthesiology, University of Colorado, Aurora, Colorado
Martin Culwick, MB,ChB, BSc, FANZCA, MIT Department of Anesthesia, Queensland University of Technology, and Royal Brisbane and Womens Hospital, Australia
Alan F. Merry, MB, ChB, FANZCA, FFPMANZCA, FRCA Department of Anesthesiology, University of Auckland and Auckland City Hospital, New Zealand
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Brief History
We cannot fix what we do not know. From the very first anesthetic, there have been reported cases of harm.1 Early on, these reports were often anecdotal, passed by word-ofmouth or letter among a small group of colleagues. Over time, anesthesiologists began to focus on the most devastating “incidents” associated with anesthesia and unexplained deaths. One of the first large studies on anesthesia mortality reviewed 599,548 patients who had received anesthesia2 and noted an overall mortality related partly or wholly to anesthesia of 1 in 3000 cases. The authors noted that there was an increase in anesthesia death rate when muscle relaxants were used, but accepted that there was no evidence that this was directly related to the drugs. The mechanism of these deaths was frequently cardiovascular collapse and the authors implied that this might have been because of the ganglion-blocking effect of these drugs. The relaxants used at that time included tubocurarine, decamethonium, succinylcholine, gallamine, and di-methyl tubocurarine. Anesthesiology departments throughout the world were encouraged to hold local mortality review meetings that subsequently included reviews of morbidity as well. Some of the best long-term mortality review data come from Australia. In 1959, a special committee to investigate deaths occurring under REPRINTS: PATRICK J. GUFFEY, MD, DEPARTMENT OF ANESTHESIOLOGY, UNIVERSITY E-MAIL: [email protected]
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COLORADO, AURORA, CO.
INTERNATIONAL ANESTHESIOLOGY CLINICS Volume 52, Number 1, 69–83 r 2014, Lippincott Williams & Wilkins
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anesthesia was set up in New South Wales.3 After this, mortality review committees were established in South Australia (1969), Queensland (1975), Victoria (1976), and Western Australia (1978).4 Since 1985, the information from these committees has been amalgamated into a National (and, at least potentially, binational with New Zealand) Triennial Report on Anesthesia-related Mortality.5 The most recent estimate from this process, for the years 2006 to 2008, suggests a rate of about 1 in 55000 for deaths wholly or partially related to anesthesia. Alternatively, this can be presented as a rate of 2.79 deaths per million population per annum.5 Flanagan first described the critical incident technique in 1954.6 Safren and Chapanis7 published a study on critical incidents involving hospital medication errors in 1960. The concept of critical incident monitoring in anesthesia was introduced to the United States by Jeffrey Cooper in 1978.8 The purpose of incident monitoring is to identify hazards and improve safety. Incident monitoring is most commonly associated with the airline industry,9 but it is also used in other high-risk industries such as nuclear power10 and petrochemical refining.11 The Anesthesia Patient Safety Foundation was formed in 1985 by E.C. (Jeep) Pierce Jr with a vision “that no patient shall be harmed from anesthesia.”12 The Anesthesia Patient Safety Foundation publishes a quarterly newsletter that is the anesthesia publication with the largest circulation in the world. Professor Bill Runciman subsequently established the Australian Patient Safety Foundation13 and launched the Anaesthetic Incident Monitoring Study (AIMS).14 Initially, AIMS was designed as a craft-oriented tool for anesthesiologists. It was very well received, and many papers have been published on the basis of the AIMS data. The contribution of this work to improving patient safety in anesthesia has been outstanding. Subsequently, the system was extended to cover a much wider range of incidents in health care, underpinned by a universal patient safety classification.15 The Australian and New Zealand Tripartite Anaesthesia Data Committee (ANZTADC) was established to revitalize the concept of a craft-oriented incident reporting system, in the belief that anesthesiologists tended to engage more readily with their own system (as they had with the AIMS) than with any of the more generic systems, however good they might be. The advent of web-based technologies provided additional impetus to the project. A more focused taxonomy relevant to the speciality was developed, taking account of several published taxonomies including that of the original AIMS, the Swiss Critical Incident Reporting System (created in the 1990s and still in use by Swiss anesthesiologists today), and the National Patient Safety Agency’s incident reporting system. Thus, WebAIRS was born: a web-based online incident reporting system for members of the 3 parent bodies of the ANZTADC (The Australian and New Zealand College of Anaesthetists, The Australian Society of Anaesthetists, and the New Zealand www.anesthesiaclinics.com
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Society of Anaesthetists). The importance of narrative reports was recognized, and a narrative section was given ample space on the web page. An aim was for the anesthesiologists to be able to enter the data without prior training. There are no mandatory fields, as it was thought that these might discourage some users from reporting. In 2010, the Anesthesia Quality Institute (AQI) began to develop a system for the United States. Meetings between AQI and ANZTADC commenced and during 2011 the taxonomies of the systems were aligned.
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Principles of Incident Reporting
Incident reporting is based on the principle of learning from events, which include near misses and adverse outcomes. Learning from experience (ie, the outcomes of individual practice) is an important part of every clinician’s training and continuing education, but there are limitations to this approach. To learn from events it is important to analyze their root causes,16 but this can be difficult (see below) and the cause of critical incidents is often multifactorial. Furthermore, individual events may be less informative than information amalgamated from several similar incidents. The more events that are reported, the more likely detection of rare events becomes. Most importantly, learning from experience may often come at the expense of the death or injury of patients or staff (including anesthesiologists). A near miss is an event that did not cause patient harm, but had the potential to.17–19 Learning from reports of near misses has the potential to prevent some of this harm before it occurs.2,20 Almost a century ago, Heinrich proposed the concept of the safety pyramid.21 Events of actual patient harm are at the apex of the pyramid, and near misses populate its larger, lower portion. The original ratio described by Heinrich was 1 major injury to 30 minor injuries and 300 near misses. Similar ratios were reported by Bird and Germain22 in 1956, ConocoPhilips in 2002, and the University of California, San Francisco, more recently.18 It follows that there is much greater opportunity to detect and learn from the precursors of patient harm, than from the small number of events that actually do result in serious harm.18,19 These advantages are even more marked for nationally centralized incident reporting, which also provides for lessons from one center to be disseminated widely instead of just locally. Incident reporting can also provide some indication of the effectiveness of changes implemented to improve the system. The drawback here is that voluntary reporting and the lack of denominator data limit the accurate estimation of the rates at which events occur. In contrast, changes in the patterns of events can be seen. For example, incidents related to unintended circuit disconnection have become www.anesthesiaclinics.com
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much less common since the introduction to routine clinical practice of pulse oximetry and capnography.23 Examples of improvements to patient safety in anesthesia that have come about at least partly in response to incident reporting are numerous (see below). Nevertheless, incident monitoring in anesthesia has yet to reach the formalized approach and “buy in” of the aviation industry. It has been said that the “success of incident reporting in improving safety, is yet to be seen in health care systems.”13 The potential for benefit is certainly present, but participation has been less than might be expected from a professional group with a reputation for a strong culture of patient safety. There are various possible reasons for this (Table 1).24–28 Notably, a poor reporting culture is common among physicians. Physicians utilize incident reporting systems at the lowest rate of all professional groups within health care, although the relationship of rates of reporting to the actual incidence of adverse events is unknown.24,29,30 Many reporting systems are focused on actual cases of morbidity and mortality and have very low physician participation.24 Reporting systems are frequently complicated and arduous, which discourages their use and promotes under-reporting.25–28 Rowin found that only 1.1% of incident reports filed at 29 geographically dispersed hospitals were made by physicians. He further identified only 163 physician-initiated reports of near misses of a total of 226,000 incidents. This represented one near miss reported by a physician per 45,000 inpatient days, and suggests considerable under-reporting, compared with cases of actual harm.24,31 Table 2 lists some principles to incentivize reporting.18 There is a tension between the value of being able to feed commentary back to individual reporters or to follow-up and obtain information from them, and between the perceived risks of incident reporting. Fear of consequences and distrust of the system contributes to low reporting rates. One way of addressing this is to offer an anonymous option—this removes a barrier if the potential reporter is concerned that the near miss may be used in a punitive manner.18 Furthermore, when an anesthesiologist takes time to Table 1. Disincentives for Reporting Adverse Events18,24–28 Poor education about what constitutes an event Concern over legal or credentialing consequences Personal shame Fear of implicating others Time-consuming processes Systems that are difficult to access Lack of anonymity Potentially discoverable information Slow infrastructure Arduous, poorly designed interfaces Lack of feedback and follow-up, no perceived value to the department www.anesthesiaclinics.com
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Table 2.
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Features of a Successful Incident Reporting System18
Factors That Incentivize Reporting Secure and nondiscoverable data Quick entry time (< 1 min) and ease of use Accessibility of the system The capture of both near misses and incidents of patient harm An option of anonymity for near misses Data searchable by the department QI committee Summary reports to department and hospital
report an event or a near miss, there is an expectation that this report will be used to improve practice. A lack of follow-up lowers reporting. There has been a shift in the response to errors in health care. Today it is expected that reports will be handled in a nonpunitive manner.13 The airline industry recognized this years ago, and their model is a benchmark for error recognition and prospective risk reduction.14
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Local Incident Reporting
The regular discussion of anesthetic mortality within anesthetic departments probably began in the 1950s and followed investigations into obstetric deaths in the 1930s and 1940s. Discussion of mortality was subsequently extended to include morbidity. Various local initiatives to improve safety emerged from this process, and occasionally the messages were propagated by case reports or other publications. However, there was no formal mechanism for wider dissemination. Many anesthesia departments, or even individual sole practitioners, have some sort of morbidity and mortality review process, often using paper forms for this purpose. However, a more formal process of reporting, tracking, and analyzing near miss events is rare in the anesthesia community.18 Analyzing large numbers of events requires a substantial commitment on behalf of the department and its members and is difficult without a well-designed electronic solution. Robust and sophisticated analysis is often required to identify effective improvements to the system. The process of root cause analysis requires training in error analysis techniques. Investment in training at least 1 individual in a department or group in root cause analysis techniques may increase the yield from a reporting system. Larger departments may utilize a committee of interested anesthesiologists to perform this function, but it is time and resource consuming. Alternatively, it may be helpful to engage staff trained in this area from other disciplines within the hospital. www.anesthesiaclinics.com
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Hospital Collaboration and Dual Reporting
Most hospitals maintain a process for reporting, categorizing, and reviewing events internally. Regulatory bodies, such as the Joint Commission in the United States, mandate some of these functions. Simultaneously, departments have a vested interest in reporting their incidents and near misses locally. Anesthesiologists may be asked to report into both systems, and the extra work involved in dual reporting is a substantial disincentive to participation. Therefore, effort should be made to ensure that shared data need to be entered only once. Electronic systems may allow for collaboration to be seamless to the reporting anesthesiologist and eliminate the need for dual reporting.
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National Incident Reporting
The next logical step from local reporting is to aggregate data on a national level. In Australia and New Zealand, national incident reporting began in 1988.14 Although many incidents taken individually may appear to be of low significance, when grouped at a national level there may be obvious clusters of important incident types. Conventional root cause analysis tends to be time-consuming, and therefore methods have been developed to allow the analysis of a larger number of incidents more efficiently such as the learning from defects tool, from the Quality and Safety Research Group at the Johns Hopkins University.32 Aggregation of cases nationally provides enormous power, with a potentially lower detection threshold and faster response than nonaggregated local systems. For example, if there was an equipment malfunction of the same model of anesthesia machine in each of the 50 US states, this would probably be overlooked locally, and at the level of the state health boards. However, even if 10% of the events were reported to the national system, the problem might well be recognized. In 2011, the Anesthesia Quality Institute (USA) launched AIRS—the Anesthesia Incident Reporting System. This system was based on prior work at University of California, San Francisco, and University of Colorado, and on the WebAIRS system developed by the ANZTADC. This system features an anesthesia-specific taxonomy that facilitates efficient and accurate reporting and provides a common language for aggregating and analyzing events. A committee of content experts review cases to identify patterns and issues for further investigation. Users have the option of entering a report confidentially or anonymously. If they choose the confidential option, the system allows individual reporters to be contacted, which is very helpful when questions invariably arise. www.anesthesiaclinics.com
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Both AIRS and WebAIRS are highly customizable systems capable of being targeted to developing trends. For example, AIRS has a medicationshortage module that fires when a user indicates this as a proximal cause. Specific questions are then asked that may assist in better understanding the impact of drug shortages and provide more granular data to motivate appropriate action from local or national entities. Modules are also in development or live for many subspecialities of anesthesiology. If a user indicates that a pediatric patient was involved in the incident, additional questions are asked that are refined for pediatrics. Figure 1 illustrates a screenshot from AIRS, noting the drug shortage and respiratory depression questions that represent modules for emerging trends. Interested readers can enter a test report at http://aqiairs.org. Whereas AIRS is open to all clinicians, WebAIRS requires a brief registration process to ensure compliance with privacy regulations and confidentiality. Both systems are similar as AIRS was modeled partly from WebAIRS using the same taxonomy. WebAIRS can be accessed at http:// www.anztadc.net/, and Figure 2 represents one of the data entry forms. In an effort to reduce dual reporting, some institutions are choosing to modify their own reporting systems to mirror the AQI AIRS. This allows for local review and easy electronic transfer to the national database. In Australia and New Zealand, WebAIRS is piloting a morbidity and mortality tool to display the incidents from the local site but not from other sites. This allows the local system to be integrated into the national reporting system, avoids dual reporting, and facilitates participation. Anonymity is preserved by the use of special keys and indexes to obfuscate the origin of the report at a national level, although users have direct access to the database. At the time of writing, 791 cases have been reported to AQI AIRS and 1538 incidents to WebAIRS.
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Legal and Ethical Issues Relating to Collection of Patient Data
An absolute requirement of a national reporting system is a safe, secure, and legal method of obtaining anesthesia incident data nationwide. A list of some of the legal and ethical issues involving the collection and the use of health data is shown in Table 3. On its website, the US Department of Health and Human Services (HHS) lists 2 sets of legislation that apply to the collection of health data. These are the Health Insurance Portability and Accountability Act of 1996 (HIPPA)33 and the Patient Safety and Quality Improvement Act of 2005 (PSQIA).34 The HIPPA required that, if congress failed to pass privacy regulations by 1999, then HIPPA would enact regulations to govern individually identifiable health data.33 This resulted in the Standards for Privacy of Individually Identifiable Health Information (Privacy www.anesthesiaclinics.com
Figure 1. Anesthesia incident reporting system data entry interface.
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Figure 2. WebAIRS data entry interface.
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Rule). The goal of the Privacy Rule is to protect identifiable health data and thus govern the use and disclosure of individuals’ health information.34 The Privacy Rule is less restrictive regarding deidentified health data, but there is also a need to address the possibility of reidentification, also known as surrogate identification. Thus, if the deidentified information is highly specific (eg, it contains reference to a rare disease in a person of a particular age and who lives in a certain location), then it might be possible to guess the identity of that individual. This is particularly likely if the data set contains a small number of individuals and the data are derived from a small number of locations. The HIPPA also addresses the storage and security of the data. Some of the more important areas covered include access, authentication, confidentiality, disaster recovery, encryption, integrity, malicious software, passwords, physical safeguards, security measures, and technical safeguards. When embarking upon incident reporting projects, it should be ensured that the project is compliant with the HIPPA legislation. The goal of the PSQIA legislation is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.34 The PSQIA is also known as the Patient Safety Act and this Act authorizes the creation of Patient Safety Organizations (PSOs).34 A PSO is authorized to collect patient data and the Act protects the data from disclosure and discoverability. In the United States, the Anesthesia Quality Institute is one of 79 currently registered PSOs. Data entered into AIRS are federally protected against disclosure. From the AQI, data are further deidentified and submitted to the National Patient Safety Database maintained by the Agency for Healthcare Research and Quality. This allows the collective experience of anesthesiology to be compared with the practice of medicine in the United States. Table 3. Legal and Ethical Issues Related to Collection of Patient Data Legal and Ethical Issues
Considerations
Collection of health data
Relevant legislation HIPAA Privacy Rule PSQIA Patient Safety Organizations (PSOs) Data security principles Legal discoverability Searchable by department QI committee Moral and legal obligations Avoidance of harm Consent for data to be used for particular purposes Possible publication of the data Transparency and open disclosure Option of anonymity for particular reports
Security and discoverability of the data Ethical use of the data
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However, this focus on national aggregation means that departments really need a means of accessing their own departmental data notwithstanding the protection afforded the database as a whole. One way of doing this is through summary reports returned to each participating institution. Perhaps a better way is for each institution to be given access to just their own data, but in such a way that comparisons can be made with summary information from the national data. As indicated above, it is important to understand the limitations of such comparisons—voluntary incident reporting does not provide quantitative estimates of the rates of events. In fact, it is likely that the bestperforming institutions will also have the greatest number of reports. There is a general understanding that data will be used only for the purpose for which they have been collected—in this case to improve quality and safety of anesthesia. In some local incident reporting projects, patients normally give written consent on admission to the hospital for use of their data for quality improvement, thereby authorizing this primary purpose of data use. However, patients may not expect their data to be forwarded to another institution, such as a national incident reporting system. Similarly, a PSO may be authorized to collect data for the purpose of improving quality and safety; however, if the data are subsequently used to produce a scientific article, then additional Institutional Review Board (IRB) or ethics committee approval is likely to be required. Ethics approval may be obtained before or after the collection of the data. If approval for publication is sought after the collection of the data, it is possible that the IRB will find that the data were not collected in a manner that would meet their requirements. IRBs are likely to consider whether written consent was obtained before the data collection and whether the data were being used for a primary or secondary purpose in relation to the written consent. If it was a secondary purpose, they are likely to consider whether the secondary purpose is related to the primary purpose, whether the data are deidentified, whether any harm could occur as a result of the data use or benefit result, and whether it could be argued that there is implied consent for the secondary purpose. In the case of forwarding local incident data to a national incident reporting system, the secondary purpose is related to the primary purpose. If the data are completely deidentified, there is little risk that harm could result from the use of the data. The reason for this is that the most likely avenue for harm with the use of incident data is that the patient, the doctor, or the institution might be identified and suffer as a result. Identification of the parties involved may result in mental stress, discrimination, loss of job, or loss of reputation. It is important to appreciate that this risk may be increased by publication of the data, and thus a patient may consent to collection and nonpublic use of the data but be less willing for the same data to be published. Although deidentification may afford reasonable protection in this regard, it is www.anesthesiaclinics.com
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important to ensure that reidentification is not possible by age, disease, procedure, location, or any other parameter. A large pool of incidents, institutions, and participating practitioners also helps prevent reidentification. It could also be argued that most patients would like to know that it is possible to prevent incidents that may cause harm by disseminating the causes of incidents and producing national recommendations to prevent future occurrence. In other countries differences apply. For example, in Australia and New Zealand, there is no equivalent to a PSO. To ensure compliance with the privacy legislation in these jurisdictions, ethics approval has been obtained by ANZTADC at every participating site in Australia, and nationally in New Zealand (where a multiregional system is in place). The time for processing the applications for approval of each site may be considerable. Some have taken several months to obtain approval, whereas others have been as short as 1 week. In both Australia and New Zealand, a memorandum of agreement between ANZTADC and participating sites has been deemed prudent to ensure appropriate processes (eg, in relation to confidentiality of the data) at the local level. A particularly problematic concern with nondiscoverable data collection relates to the issue of transparency and open disclosure. Where harm has occurred, and perhaps even when harm has been narrowly averted, open disclosure is expected and the patient and institution are widely held to have the right to know all relevant information.35 However, in some jurisdictions at least, many practitioners might deem it prudent to exercise their right to silence, and they may even receive legal advice to this effect.36 A strong argument can be made that the processes of incident reporting and open disclosure should be parallel. On this basis, the incident information should be privileged, thus allowing even those who do not wish to set aside their rights to remain silent to contribute to improving the safety of the system. An important point, however, is that reporting the incident does not provide protection to other sources of information (such as patient notes) and neither does it reduce the more general obligation for openness and transparency,37 although it does leave it to the discretion of each practitioner how he or she discharges that obligation.
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Improving Anesthesia Practice: Outputs of National Reporting Systems
The goal of incident reporting is to improve the safety and quality of practice. Health care, including anesthesia, is a complex system in which outcomes are loosely coupled with interventions.38 It is therefore quite difficult to provide compelling evidence to support definitive attribution www.anesthesiaclinics.com
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of improvements in care to incident reporting. There are many examples of improvements in anesthesia to which incident reporting has at least contributed. These include the development of disconnection monitors, improvements in the gas piping and rotameters of anesthetic machines, pulse oximetry, end-tidal CO2 measurement, inspired oxygen measurement, anesthetic agent measurement, and the introduction of the World Health Organization Surgical Safety Checklist.39,40 The process of local review of incidents, with discussion about locally relevant initiatives to prevent the same things happening in the future should not be underrated as a means of improving the quality of anesthetic practice. This is an effective and motivational form of adult education, underpinned by workplace experiences. Stories are a powerful way of changing behavior, and therefore the publication of case reports based on incidents in the national database is likely to be another effective method of educating anesthetists, alerting them to particular hazards and improving patient safety. The monthly newsletter of the American Society of Anesthesiologists now contains regular reports from the AIRS database. These are edited by a substantial group of experts, all of whom are clinically practicing anesthesiologists, and are thus supported by carefully considered reviews that synthesize the messages from the incident or incidents in question, the contributors’ own experience and the literature. This is one effective way of promulgating appropriate recommendations from the amalgamated incident reports. The ANZTADC have established another method of responding to the messages in the incident reports. A clear process has been defined by which recommendations can be synthesized and endorsed by each of the 3 parent bodies and then promulgated through their official publications and websites. Reports with summaries analyzed by category have been included in these publications. Regular presentations are also made for major meetings within Australia and New Zealand.
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International Collaboration
There are several national anesthesia reporting systems in use today. However, there is yet to be any formal collaboration between these systems. In 2011 and 2012, the leaders of these efforts met at the American Society of Anesthesiologists annual meeting, and informal relationships have been established to learn from each other. As explained above, the US AIRS system and the Australian WebAIRS cooperated during the development of the former, and therefore these systems use very similar anesthesia taxonomies. This may be the first example of international collaboration in anesthesia event reporting. There are great benefits in a common simple taxonomy. Work is just beginning on comparing and perhaps aggregating events from the www.anesthesiaclinics.com
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2 systems. Our hope is that over time we will be able to expand this work worldwide. The possibility of making the web-based system accessible to low-income countries is worth serious consideration as well. The aim of incident reporting is to improve the safety of our patients everywhere. We believe the work described in this article has made a substantial contribution to that objective, but the full potential of incident reporting in anesthesia is yet to be realized.
The authors have no conflicts of interest to disclose.
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References
1. Knight PR III, Bacon DR. An unexplained death: Hannah Greener and chloroform. Anesthesiology. 2002;96:1250–1253. 2. Beecher HK, Todd DP. A study of the deaths associated with anesthesia and surgery. Ann Surg. 1954;140:2–34. 3. Holland R. Special committee investigating deaths under anaesthesia. Report on 745 classified cases, 1960-1968. Med J Aust. 1970;1:573–594. 4. Gibbs NM. Milestones in anaesthesia-related mortality and morbidity reporting in Australia. Anaesth Intensive Care. 2010;38:807–808. 5. Gibbs N. Safety of Anaesthesia in Australia. A review of anaesthesia related mortality 2006 to 2008. Melbourne: Australian and New Zealand College of Anaesthetists; 2012. 6. Flanagan JC. The critical incident technique. Psychol Bull. 1954;51:327–358. 7. Safren MA, Chapanis A. A critical incident study of hospital medication errors. Hospitals. 1960;34:32–34; passim. 8. Cooper JB, Newbower RS, Long CD, et al. Preventable anesthesia mishaps: a study of human factors. Anesthesiology. 1978;49:399–406. 9. Hansen M, McAndrews C, Berkeley E. History of Aviation Safety Oversight in the United States—Final Report. 2008. Available at: http://www.tc.faa.gov/its/worldpac/techrpt/ ar0839.pdf. 10. IAEA/NEA Agency. The IAEA/NEA Incident Reporting System—Using Operating Experience to Improve Safety. 2008. Available at: http://www-pub.iaea.org/MTCD/Publications/ PDF/Pub1453_web.pdf. 11. International Association of Oil & Gas Producers. Health and Safety Incident Reporting System User’s Guide. 2011. Available at: http://www.ogp.org.uk/pubs/444.pdf. 12. Cooper J. Patient safety and biomedical engineering. In: Kitz R, ed. This is No Humbug: Reminiscences of the Department of Anesthesia at the Massachusetts General Hospital. Boston: Department of Anesthesia and Critical Care, Massachusetts General Hospital: 2002;377–420. 13. Runciman WB. The Australian patient safety foundation. Anaesth Intensive Care. 1988;16:114–116. 14. Runciman WB, Sellen A, Webb RK, et al. The Australian incident monitoring study. Errors, incidents and accidents in anaesthetic practice. Anaesth Intensive Care. 1993;21:506–519. 15. Runciman W, Hibbert P, Thomson R, et al. Towards an International Classification for patient safety: key concepts and terms. Int J Qual Health Care. 2009;21:18–26. 16. Runciman B, Merry A, Walton M. Safety and Ethics in Healthcare: A Guide to Getting it Right. Aldershot: Ashgate; 2007. 17. Reason J. Human Error. New York: Cambridge University Press; 1990. www.anesthesiaclinics.com
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18. Guffey P, Szolnoki J, Caldwell J, et al. Design and implementation of a near-miss reporting system at a large, academic pediatric anesthesia department. Paediatr Anaesth. 2011;21:810–814. 19. Guffey P, Caldwell J. Current Results of an Anonymous Near-miss Reporting System at a Large, Academic, Multi-campus Anesthesia Department. Denver, CO: Association of University Anesthesiologists; 2010. 20. Li G, Warner M, Lang BH, et al. Epidemiology of anesthesia-related mortality in the United States, 1999-2005. Anesthesiology. 2009;110:759–765. 21. Heinrich HW. Industrial Accident Prevention: A scientific approach. New York, NY: McGraw-Hill; 1950. 22. Bird F, Germain G. Loss Control Management: Practical Loss Control Leadership. Oslo, Norway: Det Norske Veritas; 1996. 23. Runciman WB. Iatrogenic harm and anaesthesia in Australia. Anaesth Intensive Care. 2005;33:297–300. 24. Rowin EJ, Lucier D, Pauker SG, et al. Does error and adverse event reporting by physicians and nurses differ? Jt Comm J Qual Patient Saf. 2008;34:537–545. 25. Kaldjian LC, Jones EW, Wu BJ, et al. Reporting medical errors to improve patient safety: a survey of physicians in teaching hospitals. Arch Intern Med. 2008;168:40–46. 26. Kaldjian LC, Jones EW, Wu BJ, et al. Disclosing medical errors to patients: attitudes and practices of physicians and trainees. J Gen Intern Med. 2007;22:988–996. 27. Leape LL. Reporting of adverse events. N Engl J Med. 2002;347:1633–1638. 28. Taylor JA, Brownstein D, Christakis DA, et al. Use of incident reports by physicians and nurses to document medical errors in pediatric patients. Pediatrics. 2004;114:729–735. 29. Cullen DJ, Bates DW, Small SD, et al. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv. 1995;21:541–548. 30. Flynn EA, Barker KN, Pepper GA, et al. Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities. Am J Health Syst Pharm. 2002;59:436–446. 31. Milch CE, Salem ND, Pauker SG, et al. Voluntary electronic reporting of medical errors and adverse events. An analysis of 92,547 reports from 26 acute care hospitals. J Gen Intern Med. 2006;21:165–170. 32. Quality and Safety Research Group. Comprehensive unit based safety program. 2008 4/26/13. Available at: http://www.hopkinsmedicine.org/quality_safety_research_group/ our_projects/stop_bsi/toolkits_resources/cusp_toolkit.html. Accessed April 26, 2013. 33. Summary of the HIPPA Privacy Rule OCR Privacy Brief. 2003 4/17/13. Available at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf. Accessed April 17, 2013. 34. Agency for Healthcare Research and Quality. The Patient Safety and Quality Improvement Act of 2005. Rockville, MD: Agency for Healthcare Research and Quality; 2008. 35. Bismark MM, Gogos AJ, Clark RB, et al. Legal disputes over duties to disclose treatment risks to patients: a review of negligence claims and complaints in Australia. PLoS Med. 2012;9:e1001283. 36. Studdert DM, Melio MM, Gawande AA, et al. Disclosure of medical injury to patients: an improbable risk management strategy. Health Aff. 2007;26:215–226. 37. Runciman WB, Merry AF, Tito F. Error, blame, and the law in health care—an antipodean perspective. Ann Intern Med. 2003;138:974–979. 38. Perrow C. Normal Accidents: Living with High Risk Technologies. 2nd ed. Princeton New Jersey: Princeton University Press; 1999. 39. The WHO Surgical Safety Checklist First Edition. Available at: http://www.who.int/ patientsafety/challenge/safe.surgery/en/index.html. Accessed March 17, 2010. 40. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491–499. www.anesthesiaclinics.com
Patrick J. Guffey, MD Department of Anesthesiology, University of Colorado, Aurora, Colorado
Martin Culwick, MB,ChB, BSc, FANZCA, MIT Department of Anesthesia, Queensland University of Technology, and Royal Brisbane and Womens Hospital, Australia
Alan F. Merry, MB, ChB, FANZCA, FFPMANZCA, FRCA Department of Anesthesiology, University of Auckland and Auckland City Hospital, New Zealand
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Brief History
We cannot fix what we do not know. From the very first anesthetic, there have been reported cases of harm.1 Early on, these reports were often anecdotal, passed by word-ofmouth or letter among a small group of colleagues. Over time, anesthesiologists began to focus on the most devastating “incidents” associated with anesthesia and unexplained deaths. One of the first large studies on anesthesia mortality reviewed 599,548 patients who had received anesthesia2 and noted an overall mortality related partly or wholly to anesthesia of 1 in 3000 cases. The authors noted that there was an increase in anesthesia death rate when muscle relaxants were used, but accepted that there was no evidence that this was directly related to the drugs. The mechanism of these deaths was frequently cardiovascular collapse and the authors implied that this might have been because of the ganglion-blocking effect of these drugs. The relaxants used at that time included tubocurarine, decamethonium, succinylcholine, gallamine, and di-methyl tubocurarine. Anesthesiology departments throughout the world were encouraged to hold local mortality review meetings that subsequently included reviews of morbidity as well. Some of the best long-term mortality review data come from Australia. In 1959, a special committee to investigate deaths occurring under REPRINTS: PATRICK J. GUFFEY, MD, DEPARTMENT OF ANESTHESIOLOGY, UNIVERSITY E-MAIL: [email protected]
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COLORADO, AURORA, CO.
INTERNATIONAL ANESTHESIOLOGY CLINICS Volume 52, Number 1, 69–83 r 2014, Lippincott Williams & Wilkins
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anesthesia was set up in New South Wales.3 After this, mortality review committees were established in South Australia (1969), Queensland (1975), Victoria (1976), and Western Australia (1978).4 Since 1985, the information from these committees has been amalgamated into a National (and, at least potentially, binational with New Zealand) Triennial Report on Anesthesia-related Mortality.5 The most recent estimate from this process, for the years 2006 to 2008, suggests a rate of about 1 in 55000 for deaths wholly or partially related to anesthesia. Alternatively, this can be presented as a rate of 2.79 deaths per million population per annum.5 Flanagan first described the critical incident technique in 1954.6 Safren and Chapanis7 published a study on critical incidents involving hospital medication errors in 1960. The concept of critical incident monitoring in anesthesia was introduced to the United States by Jeffrey Cooper in 1978.8 The purpose of incident monitoring is to identify hazards and improve safety. Incident monitoring is most commonly associated with the airline industry,9 but it is also used in other high-risk industries such as nuclear power10 and petrochemical refining.11 The Anesthesia Patient Safety Foundation was formed in 1985 by E.C. (Jeep) Pierce Jr with a vision “that no patient shall be harmed from anesthesia.”12 The Anesthesia Patient Safety Foundation publishes a quarterly newsletter that is the anesthesia publication with the largest circulation in the world. Professor Bill Runciman subsequently established the Australian Patient Safety Foundation13 and launched the Anaesthetic Incident Monitoring Study (AIMS).14 Initially, AIMS was designed as a craft-oriented tool for anesthesiologists. It was very well received, and many papers have been published on the basis of the AIMS data. The contribution of this work to improving patient safety in anesthesia has been outstanding. Subsequently, the system was extended to cover a much wider range of incidents in health care, underpinned by a universal patient safety classification.15 The Australian and New Zealand Tripartite Anaesthesia Data Committee (ANZTADC) was established to revitalize the concept of a craft-oriented incident reporting system, in the belief that anesthesiologists tended to engage more readily with their own system (as they had with the AIMS) than with any of the more generic systems, however good they might be. The advent of web-based technologies provided additional impetus to the project. A more focused taxonomy relevant to the speciality was developed, taking account of several published taxonomies including that of the original AIMS, the Swiss Critical Incident Reporting System (created in the 1990s and still in use by Swiss anesthesiologists today), and the National Patient Safety Agency’s incident reporting system. Thus, WebAIRS was born: a web-based online incident reporting system for members of the 3 parent bodies of the ANZTADC (The Australian and New Zealand College of Anaesthetists, The Australian Society of Anaesthetists, and the New Zealand www.anesthesiaclinics.com
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Society of Anaesthetists). The importance of narrative reports was recognized, and a narrative section was given ample space on the web page. An aim was for the anesthesiologists to be able to enter the data without prior training. There are no mandatory fields, as it was thought that these might discourage some users from reporting. In 2010, the Anesthesia Quality Institute (AQI) began to develop a system for the United States. Meetings between AQI and ANZTADC commenced and during 2011 the taxonomies of the systems were aligned.
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Principles of Incident Reporting
Incident reporting is based on the principle of learning from events, which include near misses and adverse outcomes. Learning from experience (ie, the outcomes of individual practice) is an important part of every clinician’s training and continuing education, but there are limitations to this approach. To learn from events it is important to analyze their root causes,16 but this can be difficult (see below) and the cause of critical incidents is often multifactorial. Furthermore, individual events may be less informative than information amalgamated from several similar incidents. The more events that are reported, the more likely detection of rare events becomes. Most importantly, learning from experience may often come at the expense of the death or injury of patients or staff (including anesthesiologists). A near miss is an event that did not cause patient harm, but had the potential to.17–19 Learning from reports of near misses has the potential to prevent some of this harm before it occurs.2,20 Almost a century ago, Heinrich proposed the concept of the safety pyramid.21 Events of actual patient harm are at the apex of the pyramid, and near misses populate its larger, lower portion. The original ratio described by Heinrich was 1 major injury to 30 minor injuries and 300 near misses. Similar ratios were reported by Bird and Germain22 in 1956, ConocoPhilips in 2002, and the University of California, San Francisco, more recently.18 It follows that there is much greater opportunity to detect and learn from the precursors of patient harm, than from the small number of events that actually do result in serious harm.18,19 These advantages are even more marked for nationally centralized incident reporting, which also provides for lessons from one center to be disseminated widely instead of just locally. Incident reporting can also provide some indication of the effectiveness of changes implemented to improve the system. The drawback here is that voluntary reporting and the lack of denominator data limit the accurate estimation of the rates at which events occur. In contrast, changes in the patterns of events can be seen. For example, incidents related to unintended circuit disconnection have become www.anesthesiaclinics.com
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much less common since the introduction to routine clinical practice of pulse oximetry and capnography.23 Examples of improvements to patient safety in anesthesia that have come about at least partly in response to incident reporting are numerous (see below). Nevertheless, incident monitoring in anesthesia has yet to reach the formalized approach and “buy in” of the aviation industry. It has been said that the “success of incident reporting in improving safety, is yet to be seen in health care systems.”13 The potential for benefit is certainly present, but participation has been less than might be expected from a professional group with a reputation for a strong culture of patient safety. There are various possible reasons for this (Table 1).24–28 Notably, a poor reporting culture is common among physicians. Physicians utilize incident reporting systems at the lowest rate of all professional groups within health care, although the relationship of rates of reporting to the actual incidence of adverse events is unknown.24,29,30 Many reporting systems are focused on actual cases of morbidity and mortality and have very low physician participation.24 Reporting systems are frequently complicated and arduous, which discourages their use and promotes under-reporting.25–28 Rowin found that only 1.1% of incident reports filed at 29 geographically dispersed hospitals were made by physicians. He further identified only 163 physician-initiated reports of near misses of a total of 226,000 incidents. This represented one near miss reported by a physician per 45,000 inpatient days, and suggests considerable under-reporting, compared with cases of actual harm.24,31 Table 2 lists some principles to incentivize reporting.18 There is a tension between the value of being able to feed commentary back to individual reporters or to follow-up and obtain information from them, and between the perceived risks of incident reporting. Fear of consequences and distrust of the system contributes to low reporting rates. One way of addressing this is to offer an anonymous option—this removes a barrier if the potential reporter is concerned that the near miss may be used in a punitive manner.18 Furthermore, when an anesthesiologist takes time to Table 1. Disincentives for Reporting Adverse Events18,24–28 Poor education about what constitutes an event Concern over legal or credentialing consequences Personal shame Fear of implicating others Time-consuming processes Systems that are difficult to access Lack of anonymity Potentially discoverable information Slow infrastructure Arduous, poorly designed interfaces Lack of feedback and follow-up, no perceived value to the department www.anesthesiaclinics.com
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Table 2.
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Features of a Successful Incident Reporting System18
Factors That Incentivize Reporting Secure and nondiscoverable data Quick entry time (< 1 min) and ease of use Accessibility of the system The capture of both near misses and incidents of patient harm An option of anonymity for near misses Data searchable by the department QI committee Summary reports to department and hospital
report an event or a near miss, there is an expectation that this report will be used to improve practice. A lack of follow-up lowers reporting. There has been a shift in the response to errors in health care. Today it is expected that reports will be handled in a nonpunitive manner.13 The airline industry recognized this years ago, and their model is a benchmark for error recognition and prospective risk reduction.14
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Local Incident Reporting
The regular discussion of anesthetic mortality within anesthetic departments probably began in the 1950s and followed investigations into obstetric deaths in the 1930s and 1940s. Discussion of mortality was subsequently extended to include morbidity. Various local initiatives to improve safety emerged from this process, and occasionally the messages were propagated by case reports or other publications. However, there was no formal mechanism for wider dissemination. Many anesthesia departments, or even individual sole practitioners, have some sort of morbidity and mortality review process, often using paper forms for this purpose. However, a more formal process of reporting, tracking, and analyzing near miss events is rare in the anesthesia community.18 Analyzing large numbers of events requires a substantial commitment on behalf of the department and its members and is difficult without a well-designed electronic solution. Robust and sophisticated analysis is often required to identify effective improvements to the system. The process of root cause analysis requires training in error analysis techniques. Investment in training at least 1 individual in a department or group in root cause analysis techniques may increase the yield from a reporting system. Larger departments may utilize a committee of interested anesthesiologists to perform this function, but it is time and resource consuming. Alternatively, it may be helpful to engage staff trained in this area from other disciplines within the hospital. www.anesthesiaclinics.com
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Hospital Collaboration and Dual Reporting
Most hospitals maintain a process for reporting, categorizing, and reviewing events internally. Regulatory bodies, such as the Joint Commission in the United States, mandate some of these functions. Simultaneously, departments have a vested interest in reporting their incidents and near misses locally. Anesthesiologists may be asked to report into both systems, and the extra work involved in dual reporting is a substantial disincentive to participation. Therefore, effort should be made to ensure that shared data need to be entered only once. Electronic systems may allow for collaboration to be seamless to the reporting anesthesiologist and eliminate the need for dual reporting.
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National Incident Reporting
The next logical step from local reporting is to aggregate data on a national level. In Australia and New Zealand, national incident reporting began in 1988.14 Although many incidents taken individually may appear to be of low significance, when grouped at a national level there may be obvious clusters of important incident types. Conventional root cause analysis tends to be time-consuming, and therefore methods have been developed to allow the analysis of a larger number of incidents more efficiently such as the learning from defects tool, from the Quality and Safety Research Group at the Johns Hopkins University.32 Aggregation of cases nationally provides enormous power, with a potentially lower detection threshold and faster response than nonaggregated local systems. For example, if there was an equipment malfunction of the same model of anesthesia machine in each of the 50 US states, this would probably be overlooked locally, and at the level of the state health boards. However, even if 10% of the events were reported to the national system, the problem might well be recognized. In 2011, the Anesthesia Quality Institute (USA) launched AIRS—the Anesthesia Incident Reporting System. This system was based on prior work at University of California, San Francisco, and University of Colorado, and on the WebAIRS system developed by the ANZTADC. This system features an anesthesia-specific taxonomy that facilitates efficient and accurate reporting and provides a common language for aggregating and analyzing events. A committee of content experts review cases to identify patterns and issues for further investigation. Users have the option of entering a report confidentially or anonymously. If they choose the confidential option, the system allows individual reporters to be contacted, which is very helpful when questions invariably arise. www.anesthesiaclinics.com
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Both AIRS and WebAIRS are highly customizable systems capable of being targeted to developing trends. For example, AIRS has a medicationshortage module that fires when a user indicates this as a proximal cause. Specific questions are then asked that may assist in better understanding the impact of drug shortages and provide more granular data to motivate appropriate action from local or national entities. Modules are also in development or live for many subspecialities of anesthesiology. If a user indicates that a pediatric patient was involved in the incident, additional questions are asked that are refined for pediatrics. Figure 1 illustrates a screenshot from AIRS, noting the drug shortage and respiratory depression questions that represent modules for emerging trends. Interested readers can enter a test report at http://aqiairs.org. Whereas AIRS is open to all clinicians, WebAIRS requires a brief registration process to ensure compliance with privacy regulations and confidentiality. Both systems are similar as AIRS was modeled partly from WebAIRS using the same taxonomy. WebAIRS can be accessed at http:// www.anztadc.net/, and Figure 2 represents one of the data entry forms. In an effort to reduce dual reporting, some institutions are choosing to modify their own reporting systems to mirror the AQI AIRS. This allows for local review and easy electronic transfer to the national database. In Australia and New Zealand, WebAIRS is piloting a morbidity and mortality tool to display the incidents from the local site but not from other sites. This allows the local system to be integrated into the national reporting system, avoids dual reporting, and facilitates participation. Anonymity is preserved by the use of special keys and indexes to obfuscate the origin of the report at a national level, although users have direct access to the database. At the time of writing, 791 cases have been reported to AQI AIRS and 1538 incidents to WebAIRS.
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Legal and Ethical Issues Relating to Collection of Patient Data
An absolute requirement of a national reporting system is a safe, secure, and legal method of obtaining anesthesia incident data nationwide. A list of some of the legal and ethical issues involving the collection and the use of health data is shown in Table 3. On its website, the US Department of Health and Human Services (HHS) lists 2 sets of legislation that apply to the collection of health data. These are the Health Insurance Portability and Accountability Act of 1996 (HIPPA)33 and the Patient Safety and Quality Improvement Act of 2005 (PSQIA).34 The HIPPA required that, if congress failed to pass privacy regulations by 1999, then HIPPA would enact regulations to govern individually identifiable health data.33 This resulted in the Standards for Privacy of Individually Identifiable Health Information (Privacy www.anesthesiaclinics.com
Figure 1. Anesthesia incident reporting system data entry interface.
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Figure 2. WebAIRS data entry interface.
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Rule). The goal of the Privacy Rule is to protect identifiable health data and thus govern the use and disclosure of individuals’ health information.34 The Privacy Rule is less restrictive regarding deidentified health data, but there is also a need to address the possibility of reidentification, also known as surrogate identification. Thus, if the deidentified information is highly specific (eg, it contains reference to a rare disease in a person of a particular age and who lives in a certain location), then it might be possible to guess the identity of that individual. This is particularly likely if the data set contains a small number of individuals and the data are derived from a small number of locations. The HIPPA also addresses the storage and security of the data. Some of the more important areas covered include access, authentication, confidentiality, disaster recovery, encryption, integrity, malicious software, passwords, physical safeguards, security measures, and technical safeguards. When embarking upon incident reporting projects, it should be ensured that the project is compliant with the HIPPA legislation. The goal of the PSQIA legislation is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.34 The PSQIA is also known as the Patient Safety Act and this Act authorizes the creation of Patient Safety Organizations (PSOs).34 A PSO is authorized to collect patient data and the Act protects the data from disclosure and discoverability. In the United States, the Anesthesia Quality Institute is one of 79 currently registered PSOs. Data entered into AIRS are federally protected against disclosure. From the AQI, data are further deidentified and submitted to the National Patient Safety Database maintained by the Agency for Healthcare Research and Quality. This allows the collective experience of anesthesiology to be compared with the practice of medicine in the United States. Table 3. Legal and Ethical Issues Related to Collection of Patient Data Legal and Ethical Issues
Considerations
Collection of health data
Relevant legislation HIPAA Privacy Rule PSQIA Patient Safety Organizations (PSOs) Data security principles Legal discoverability Searchable by department QI committee Moral and legal obligations Avoidance of harm Consent for data to be used for particular purposes Possible publication of the data Transparency and open disclosure Option of anonymity for particular reports
Security and discoverability of the data Ethical use of the data
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However, this focus on national aggregation means that departments really need a means of accessing their own departmental data notwithstanding the protection afforded the database as a whole. One way of doing this is through summary reports returned to each participating institution. Perhaps a better way is for each institution to be given access to just their own data, but in such a way that comparisons can be made with summary information from the national data. As indicated above, it is important to understand the limitations of such comparisons—voluntary incident reporting does not provide quantitative estimates of the rates of events. In fact, it is likely that the bestperforming institutions will also have the greatest number of reports. There is a general understanding that data will be used only for the purpose for which they have been collected—in this case to improve quality and safety of anesthesia. In some local incident reporting projects, patients normally give written consent on admission to the hospital for use of their data for quality improvement, thereby authorizing this primary purpose of data use. However, patients may not expect their data to be forwarded to another institution, such as a national incident reporting system. Similarly, a PSO may be authorized to collect data for the purpose of improving quality and safety; however, if the data are subsequently used to produce a scientific article, then additional Institutional Review Board (IRB) or ethics committee approval is likely to be required. Ethics approval may be obtained before or after the collection of the data. If approval for publication is sought after the collection of the data, it is possible that the IRB will find that the data were not collected in a manner that would meet their requirements. IRBs are likely to consider whether written consent was obtained before the data collection and whether the data were being used for a primary or secondary purpose in relation to the written consent. If it was a secondary purpose, they are likely to consider whether the secondary purpose is related to the primary purpose, whether the data are deidentified, whether any harm could occur as a result of the data use or benefit result, and whether it could be argued that there is implied consent for the secondary purpose. In the case of forwarding local incident data to a national incident reporting system, the secondary purpose is related to the primary purpose. If the data are completely deidentified, there is little risk that harm could result from the use of the data. The reason for this is that the most likely avenue for harm with the use of incident data is that the patient, the doctor, or the institution might be identified and suffer as a result. Identification of the parties involved may result in mental stress, discrimination, loss of job, or loss of reputation. It is important to appreciate that this risk may be increased by publication of the data, and thus a patient may consent to collection and nonpublic use of the data but be less willing for the same data to be published. Although deidentification may afford reasonable protection in this regard, it is www.anesthesiaclinics.com
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important to ensure that reidentification is not possible by age, disease, procedure, location, or any other parameter. A large pool of incidents, institutions, and participating practitioners also helps prevent reidentification. It could also be argued that most patients would like to know that it is possible to prevent incidents that may cause harm by disseminating the causes of incidents and producing national recommendations to prevent future occurrence. In other countries differences apply. For example, in Australia and New Zealand, there is no equivalent to a PSO. To ensure compliance with the privacy legislation in these jurisdictions, ethics approval has been obtained by ANZTADC at every participating site in Australia, and nationally in New Zealand (where a multiregional system is in place). The time for processing the applications for approval of each site may be considerable. Some have taken several months to obtain approval, whereas others have been as short as 1 week. In both Australia and New Zealand, a memorandum of agreement between ANZTADC and participating sites has been deemed prudent to ensure appropriate processes (eg, in relation to confidentiality of the data) at the local level. A particularly problematic concern with nondiscoverable data collection relates to the issue of transparency and open disclosure. Where harm has occurred, and perhaps even when harm has been narrowly averted, open disclosure is expected and the patient and institution are widely held to have the right to know all relevant information.35 However, in some jurisdictions at least, many practitioners might deem it prudent to exercise their right to silence, and they may even receive legal advice to this effect.36 A strong argument can be made that the processes of incident reporting and open disclosure should be parallel. On this basis, the incident information should be privileged, thus allowing even those who do not wish to set aside their rights to remain silent to contribute to improving the safety of the system. An important point, however, is that reporting the incident does not provide protection to other sources of information (such as patient notes) and neither does it reduce the more general obligation for openness and transparency,37 although it does leave it to the discretion of each practitioner how he or she discharges that obligation.
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Improving Anesthesia Practice: Outputs of National Reporting Systems
The goal of incident reporting is to improve the safety and quality of practice. Health care, including anesthesia, is a complex system in which outcomes are loosely coupled with interventions.38 It is therefore quite difficult to provide compelling evidence to support definitive attribution www.anesthesiaclinics.com
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of improvements in care to incident reporting. There are many examples of improvements in anesthesia to which incident reporting has at least contributed. These include the development of disconnection monitors, improvements in the gas piping and rotameters of anesthetic machines, pulse oximetry, end-tidal CO2 measurement, inspired oxygen measurement, anesthetic agent measurement, and the introduction of the World Health Organization Surgical Safety Checklist.39,40 The process of local review of incidents, with discussion about locally relevant initiatives to prevent the same things happening in the future should not be underrated as a means of improving the quality of anesthetic practice. This is an effective and motivational form of adult education, underpinned by workplace experiences. Stories are a powerful way of changing behavior, and therefore the publication of case reports based on incidents in the national database is likely to be another effective method of educating anesthetists, alerting them to particular hazards and improving patient safety. The monthly newsletter of the American Society of Anesthesiologists now contains regular reports from the AIRS database. These are edited by a substantial group of experts, all of whom are clinically practicing anesthesiologists, and are thus supported by carefully considered reviews that synthesize the messages from the incident or incidents in question, the contributors’ own experience and the literature. This is one effective way of promulgating appropriate recommendations from the amalgamated incident reports. The ANZTADC have established another method of responding to the messages in the incident reports. A clear process has been defined by which recommendations can be synthesized and endorsed by each of the 3 parent bodies and then promulgated through their official publications and websites. Reports with summaries analyzed by category have been included in these publications. Regular presentations are also made for major meetings within Australia and New Zealand.
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International Collaboration
There are several national anesthesia reporting systems in use today. However, there is yet to be any formal collaboration between these systems. In 2011 and 2012, the leaders of these efforts met at the American Society of Anesthesiologists annual meeting, and informal relationships have been established to learn from each other. As explained above, the US AIRS system and the Australian WebAIRS cooperated during the development of the former, and therefore these systems use very similar anesthesia taxonomies. This may be the first example of international collaboration in anesthesia event reporting. There are great benefits in a common simple taxonomy. Work is just beginning on comparing and perhaps aggregating events from the www.anesthesiaclinics.com
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2 systems. Our hope is that over time we will be able to expand this work worldwide. The possibility of making the web-based system accessible to low-income countries is worth serious consideration as well. The aim of incident reporting is to improve the safety of our patients everywhere. We believe the work described in this article has made a substantial contribution to that objective, but the full potential of incident reporting in anesthesia is yet to be realized.
The authors have no conflicts of interest to disclose.
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References
1. Knight PR III, Bacon DR. An unexplained death: Hannah Greener and chloroform. Anesthesiology. 2002;96:1250–1253. 2. Beecher HK, Todd DP. A study of the deaths associated with anesthesia and surgery. Ann Surg. 1954;140:2–34. 3. Holland R. Special committee investigating deaths under anaesthesia. Report on 745 classified cases, 1960-1968. Med J Aust. 1970;1:573–594. 4. Gibbs NM. Milestones in anaesthesia-related mortality and morbidity reporting in Australia. Anaesth Intensive Care. 2010;38:807–808. 5. Gibbs N. Safety of Anaesthesia in Australia. A review of anaesthesia related mortality 2006 to 2008. Melbourne: Australian and New Zealand College of Anaesthetists; 2012. 6. Flanagan JC. The critical incident technique. Psychol Bull. 1954;51:327–358. 7. Safren MA, Chapanis A. A critical incident study of hospital medication errors. Hospitals. 1960;34:32–34; passim. 8. Cooper JB, Newbower RS, Long CD, et al. Preventable anesthesia mishaps: a study of human factors. Anesthesiology. 1978;49:399–406. 9. Hansen M, McAndrews C, Berkeley E. History of Aviation Safety Oversight in the United States—Final Report. 2008. Available at: http://www.tc.faa.gov/its/worldpac/techrpt/ ar0839.pdf. 10. IAEA/NEA Agency. The IAEA/NEA Incident Reporting System—Using Operating Experience to Improve Safety. 2008. Available at: http://www-pub.iaea.org/MTCD/Publications/ PDF/Pub1453_web.pdf. 11. International Association of Oil & Gas Producers. Health and Safety Incident Reporting System User’s Guide. 2011. Available at: http://www.ogp.org.uk/pubs/444.pdf. 12. Cooper J. Patient safety and biomedical engineering. In: Kitz R, ed. This is No Humbug: Reminiscences of the Department of Anesthesia at the Massachusetts General Hospital. Boston: Department of Anesthesia and Critical Care, Massachusetts General Hospital: 2002;377–420. 13. Runciman WB. The Australian patient safety foundation. Anaesth Intensive Care. 1988;16:114–116. 14. Runciman WB, Sellen A, Webb RK, et al. The Australian incident monitoring study. Errors, incidents and accidents in anaesthetic practice. Anaesth Intensive Care. 1993;21:506–519. 15. Runciman W, Hibbert P, Thomson R, et al. Towards an International Classification for patient safety: key concepts and terms. Int J Qual Health Care. 2009;21:18–26. 16. Runciman B, Merry A, Walton M. Safety and Ethics in Healthcare: A Guide to Getting it Right. Aldershot: Ashgate; 2007. 17. Reason J. Human Error. New York: Cambridge University Press; 1990. www.anesthesiaclinics.com
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18. Guffey P, Szolnoki J, Caldwell J, et al. Design and implementation of a near-miss reporting system at a large, academic pediatric anesthesia department. Paediatr Anaesth. 2011;21:810–814. 19. Guffey P, Caldwell J. Current Results of an Anonymous Near-miss Reporting System at a Large, Academic, Multi-campus Anesthesia Department. Denver, CO: Association of University Anesthesiologists; 2010. 20. Li G, Warner M, Lang BH, et al. Epidemiology of anesthesia-related mortality in the United States, 1999-2005. Anesthesiology. 2009;110:759–765. 21. Heinrich HW. Industrial Accident Prevention: A scientific approach. New York, NY: McGraw-Hill; 1950. 22. Bird F, Germain G. Loss Control Management: Practical Loss Control Leadership. Oslo, Norway: Det Norske Veritas; 1996. 23. Runciman WB. Iatrogenic harm and anaesthesia in Australia. Anaesth Intensive Care. 2005;33:297–300. 24. Rowin EJ, Lucier D, Pauker SG, et al. Does error and adverse event reporting by physicians and nurses differ? Jt Comm J Qual Patient Saf. 2008;34:537–545. 25. Kaldjian LC, Jones EW, Wu BJ, et al. Reporting medical errors to improve patient safety: a survey of physicians in teaching hospitals. Arch Intern Med. 2008;168:40–46. 26. Kaldjian LC, Jones EW, Wu BJ, et al. Disclosing medical errors to patients: attitudes and practices of physicians and trainees. J Gen Intern Med. 2007;22:988–996. 27. Leape LL. Reporting of adverse events. N Engl J Med. 2002;347:1633–1638. 28. Taylor JA, Brownstein D, Christakis DA, et al. Use of incident reports by physicians and nurses to document medical errors in pediatric patients. Pediatrics. 2004;114:729–735. 29. Cullen DJ, Bates DW, Small SD, et al. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv. 1995;21:541–548. 30. Flynn EA, Barker KN, Pepper GA, et al. Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities. Am J Health Syst Pharm. 2002;59:436–446. 31. Milch CE, Salem ND, Pauker SG, et al. Voluntary electronic reporting of medical errors and adverse events. An analysis of 92,547 reports from 26 acute care hospitals. J Gen Intern Med. 2006;21:165–170. 32. Quality and Safety Research Group. Comprehensive unit based safety program. 2008 4/26/13. Available at: http://www.hopkinsmedicine.org/quality_safety_research_group/ our_projects/stop_bsi/toolkits_resources/cusp_toolkit.html. Accessed April 26, 2013. 33. Summary of the HIPPA Privacy Rule OCR Privacy Brief. 2003 4/17/13. Available at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf. Accessed April 17, 2013. 34. Agency for Healthcare Research and Quality. The Patient Safety and Quality Improvement Act of 2005. Rockville, MD: Agency for Healthcare Research and Quality; 2008. 35. Bismark MM, Gogos AJ, Clark RB, et al. Legal disputes over duties to disclose treatment risks to patients: a review of negligence claims and complaints in Australia. PLoS Med. 2012;9:e1001283. 36. Studdert DM, Melio MM, Gawande AA, et al. Disclosure of medical injury to patients: an improbable risk management strategy. Health Aff. 2007;26:215–226. 37. Runciman WB, Merry AF, Tito F. Error, blame, and the law in health care—an antipodean perspective. Ann Intern Med. 2003;138:974–979. 38. Perrow C. Normal Accidents: Living with High Risk Technologies. 2nd ed. Princeton New Jersey: Princeton University Press; 1999. 39. The WHO Surgical Safety Checklist First Edition. Available at: http://www.who.int/ patientsafety/challenge/safe.surgery/en/index.html. Accessed March 17, 2010. 40. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491–499. www.anesthesiaclinics.com
