Jeffrey B. Cooper, Ph.D., organizer of ICPAMM, described to new participants how the organization came to be as a continuation of the International Symposium For Prevention of Anesthesia Mortality and Morbidity in Boston in 1984. Several of the roots of the APSF and worldwide initiatives in standards and safety can also be traced to that gathering. ICPAMM, he explained, is more like a "club" than a "committee;" it provides a place for anyone in the world of anesthesia who wishes to learn from colleagues about processes for studying issues related to anesthesia safety and to learn of successes and failures of programs and practices in other countries. The goal of ICPAMM parallels that of the APSF: "to ensure that no patient is harmed by anesthesia." An occasional newsletter advises of publications and safety-related events of interest.
Several themes emerged from this meeting. Critical incident studies appear to be fairly common around the world and provide a way for a country to get started in collecting data on a local level. Generally, there is now more acceptance of the idea of reporting anesthesia problems. Several studies indicate a trend toward involvement of epidemiologists and social scientists in outcome and safety research studies. Developing countries, where resources are scarce, are still able to focus on basic safety and endeavor to apply the most critical elements of what has been learned in countries where resources are more readily available. The economic pressures on medicine and on anesthesia, specifically in the U.S., are being felt in other countries as well (although one wouldnÕt necessarily conclude that from the overwhelming presence of new electronic anesthesia systems, infusion devices, data management systems and other technologies in the exhibit section of the World Congress meeting). Summaries of specific presentations follow.
Among the findings from AIMS are that problems in use of drugs appear in 8% of incidents, that endobronchial intubation is still the most frequently occurring problem leading to hypoxia, and that the most common cause of intraoperative hypertension is some type of drug administration problem. Stress, most often from self-generated haste, was seen as a contributing factor in 14% of incidents. A full third of critical incidents reported in anesthesia are related to equipment human-interface problems (only 8% were pure equipment failures, which has led recently to an industry/AIMS liaison allowing limited access to data by manufacturers).
About 20% to 30% of crisis situations would have been diagnosed sooner or managed better had a specific protocol been followed. This has led to the ABCD COVER algorithm, a plan for dealing step-by-step with untoward developments during an anesthetic. A new sub-algorithm, SCARE, has been developed: Scan every five minutes, Check on the unexpected, Alert/Ready if suspicion of a problem and turn to Emergency mode in a rapidly deteriorating situation.
The plan for the future is to include more specialties, hospitals and countries. Analysis of patient factors such as obesity are underway as is examination of preoperative assessment and preparation, the most commonly reported contributing factors in deaths in Australia. There is now also a study of clinical pathways underway.
Dr. Runciman listed several kinds of health care outcome and quality studies ongoing in Australia: incident reporting, M&M committee processes, and analysis of medical legal cases. Starting with six pilot studies funded by the federal government, there is now significant funding for incident monitoring in intensive care, general practice and obstetrics. The federal government provides money to state governments with certain requirements. There is federal and state protection from access to data. Dr. Runciman said that all the systems are in place for AIMS: collection, analysis and feedback of reports. The net for capturing anesthesia incident information is very broad and includes any event that could have caused harm to someone or any complaint. Cases are sent to the APSF via a relay station in the National Bureau of Statistics, which removes identifiers. The database is accessible only on a local area network, with no access to the outside world. The data entry system allows for "parallel coding," i.e., very complex problems can be characterized. The classification is by "natural" categories, i.e., ones that describe the data as they are described by the reporter.
They have created various guidelines, protocols, checklists and manuals for feedback of findings. Dr. Runciman has been impressed with the power of this qualitative method (this issue was raised again later in the day). Some elements of AIMS that he believes have been important to its success are that it is confidential, provides rapid feedback, is non-threatening and is inexpensive relative to case review. He estimates that the cost is about $30,000/year to operate the system in one hospital.
Via AIMS, problems heretofore unappreciated have been recognized, for instance, that infections related to failure to replace IV cannula collectively cause more morbidity than all anesthesia events combined. From other findings it has been computed that, to be cost-effective with respect to preventing overnight admissions for ambulatory day-of-surgery patient (assuming a 1/250 rule), a completely effective treatment for prevention of postoperative nausea and vomiting would have to cost less than $2.00 per anesthetic.
Separate from AIMS, the Department of Health funded an analysis of 14,000 randomly collected case notes. Sixteen percent of admissions were found to be associated with adverse events, of which 80% were deemed preventable. This extrapolates to 250,000 adverse events a year and 14,000 preventable deaths, thought to account for 10% of acute-care hospital costs. While 50% of events were in association with surgery, less than 2% were associated with anesthesia.
During the discussion, it was asked why it isn't possible to have access to individual cases since this precludes the possibility of a deeper qualitative analysis. Dr. Runciman believes that absolute anonymity is so important that it is an over-riding consideration mitigating against allowing for follow-up. Dr. Grobee questioned if there could not be ways to allow for follow-up with reporters and still allow for anonymity.
Dr. Frederick Orkin postulated that much is lost by not having more data about the patient, e.g., risk factors. Dr. Runciman believes that qualitative analysis of these data can still be productive in the absence of having complete demographics of patients, i.e., the elements of detail about what happened are sufficient to point toward designing solutions.
Dr. Russell reported on three examples of how AIMS data have been applied to change practice: To eliminate problems arising from soda lime dusting, they have worked with a manufacturer to create new procedures for loading absorbent, commonly supplied in bulk in Australia. The simple solution was to provide a larger container so the granules can be scooped instead of poured. They have been developing and testing this solution and are now publicizing findings.
Because AIMS identified that the greatest source of drug swaps and of drug-error related morbidity have involved relaxants and reversal agents, the U.S. color-coding standard was adopted. They have also introduced a special syringe with a colored plunger for these drugs. Introduction into practice began in 1994 and preliminary data suggest a sharp reduction in reported syringe swaps. But, he also believes that publicity from a symposium issue of the journal of the Australian Society of Anesthesiologists describing results of AIMS analyses, including drug swaps, may also have had an impact.
The analyses of endobronchial intubations, also reported in the symposium issue, do not appear to have been followed by a change in the rate of AIMS reports. In Australia, a mark is now placed on endotracheal tubes to indicate correct placement. But, power analysis suggests that about six years of new reports will be needed to study effects of this alteration in the tubes. This may be impractical unless there is an increasing rate of reporting.
Although only 14% of cases had an autopsy and 13% were reported in a mortality conference, surgeons were present at most autopsies and conferences. Anesthetists were rarely present, which led Dr. Dick to ponder why anesthetists appear to be less interested in what had happened.
Although these results only give a very superficial view of anesthesia mortality in Germany, they have pointed to the need for more information. The German Society of Anesthesia has established a committee on perioperative outcomes. A new database has been established and 75,000 cases have been collected to date, but no analysis has yet been performed. This is indicative of a growing change in attitude in Germany toward reporting outcomes. By law, it is not possible to retrieve information on specific cases from a hospital.
Some concern also was raised about the possibility of false incident entry by pranksters or troublemakers. It is suggested that protection issues be clarified. On the other hand, not providing access or feedback to reporters may limit interest. John Russell noted that electronic reporting of AIMS has produced higher quality, more detailed information, which he suspects is related to the spontaneity associated with the character of e-mail.
The Ministry of Health has provided protection of anonymity of the data source. Besides a quantitative approach, data will be analyzed qualitatively: Two reviewers will reach consensus on appropriateness of care and contribution of anesthesia; a third reviewer will be used in cases of disagreement. Dr. Ingram noted in the discussion that the NCEPOD is now using the same approach to overcome the bias of a single reviewer in placing blame given knowledge of the outcome.
Of 64 eligible hospitals, 61 agreed to participate. Eighty-eight percent of those have submitted at least one case since the start of data collection; the total of cases in 1995 was 376. There has been some difficulty in reporting of controls; anesthesiologists needed stimulation to submit these cases. So far, it seems that anesthesiologists are contributing to the study with enthusiasm and data collection will continue.
Dr. Montasser illustrated how this simple spreadsheet tool has been useful to define the basic needs of developing countries. He commented about the potential utility of international anesthesia minimum standards such as those adopted by the WFSA at the 1992 World Congress.
Dr. Ingram noted the gulf that exists between the developed and developing countries considering the deficiencies noted in preceding presentation and in NCEPOD. He also commented on how the press has generally concentrated on the negative aspects of the NCEPOD findings.
The next report will be out in November with a focus on one case from each surgeon to identify the characteristics of non-responders. This has produced a large number of fractured neck of femur cases.
Dr. Shimada has recently established "The Society for Safety in Medical Practice," which has 300 members and is not limited to anesthesia interests. It is unique in being open to anyone interested in safety and includes patients and their families as well as manufacturers, nurses, doctors, lawyers and researchers in medical and human sciences. Particular stress is being put on the opinions of patients in the development of guidelines for safety.
During the discussion of Dr. Shimada's report, it became clear that there still exists a problem in differentiating anesthesia vs. surgical outcomes. Dr. Gisvold noted that in their outcome reporting system in Norway, they do not try to make that separation but together with the surgeons examine all adverse outcomes.
In Thessaloniki, an outcome study from 25,000 cases at one hospital has been undertaken; the data are now being analyzed. In 1995, the forms for the AIMS study were translated to Greek and reports were solicited after announcement at a national meeting. Reports have not been forthcoming so plans are beginning for a more intense campaign to encourage participation. Planning is underway to form a Greek Foundation for Patient Safety in Acute Medicine. The broader scope is needed, she said later, to attract the support that will be required to establish such an organization in Greece.
Dr. Askitopolou described some details and results of the study of anesthesia services: a structured questionnaire was sent to anesthesia departments in 109 state hospitals, representing 70% of all anesthetics administered in Greece. The anesthesia directors of 43% of the hospitals were interviewed. The broadest spectrum of information was gathered about clinician training, case coverage, practices, equipment, etc. The survey covered about 300,000 cases in more than 500 operating rooms. Some of the findings so far were disturbing: PACU availability is limited, and those PACUs that exist have personnel with limited training. Adherence to the international standards for monitoring is limited, e.g., in 38% of departments, the presence of an anesthesiologist is not continuous, and only 46% of operating rooms have a pulse oximeter.
These findings led the newly-formed Safety Committee to propose to the Ministry of Health standards for availability of equipment, of staffing of anesthesia services, organization of PACU, accreditation of departments, of training departments, etc. The actions of the Ministry are awaited with some trepidation because of the cost implications of the recommendations. Dr. Gisvold noted that, in Norway, the publication of such standards alone by the Anesthesia Society made an impact even before the adoption by the government.
Dr. Askitopolou invited the audience to attend the European Society of Anesthesiology in Greece in September 1998, at which time she expects to report on progress in these many efforts.
Dr. Mckay felt that the view of the patient was being considered in that the wish of most importance to a patient is to wake up from the anesthetic. Dr. Orkin countered that the same is true for an airline flight, but the airlines still now pay much attention to issues of satisfaction. Others argued that such issues were not of critical importance compared to the more serious outcomes. The debate continued in this vein, with arguments about the relative importance of "safety" and "quality" and the relationship between the two. An argument was also made that safety issues would again become of greater interest as economic pressures remove the redundancies in hospital systems that have, in inexplicable ways, maintained safety despite complexity. Dr. Orkin countered that managed care had the potential to reduce adverse outcomes merely by reducing unnecessary surgery.
This ICPAMM meeting was sponsored by the Anesthesia Patient Safety Foundation (U.S.), and Dr. John Warden was responsible for all local arrangements and technical assistance. The next meeting of ICPAMM will be at the European Congress in Frankfurt in 1998.