APSF Responds to IOM Medical Error Report

The Anesthesia Patient Safety Foundation was cited as a model for efforts to help improve patient safety several times in the landmark November, 1999, Institute of Medicine report (see the APSF Newsletter, Winter 1999-2000) regarding the significant frequency and gravity of medical errors (an estimated up to 98,000 resulting deaths annually in the U.S.). Earlier this year, the APSF formulated and submitted a formal response to the IOM report, which continues to be a major focus of discussion in the U.S. Congress and the federal government. The APSF document is reprinted here. It likely will form the basis for APSF-sponsored testimony during various hearings on the subject of prevention and remedy of medical errors when these occur in upcoming legislative seasons.

Comments From the Anesthesia Patient Safety Foundation Regarding the Institute of Medicine Report, “To Err Is Human: Building a Safer Health System.”

Executive SummaryThe Anesthesia Patient Safety Foundation (APSF) is the pioneer organization dedicated to assuring patient safety. Formed in 1985 with the mission that “no patient shall be harmed from anesthesia,” APSF has been the leader in the proactive, successful efforts to dramatically improve the safety of anesthesia administration and reduce adverse events. The Executive Committee of APSF believes that the reason for the success of its efforts has been its attention to early identification of safety problems, promoting research, disseminating information, and promoting an emphasis on patient safety in clinical practice. The APSF program has helped create a cadre of experts and a culture and infrastructure devoted to promoting safety. We believe that these and other influences on the profession of anesthesia, in particular the strong support of the American Society of Anesthesiologists and other anesthesia professional societies, have combined to produce our common goal: maximum safety for all patients undergoing anesthesia. We stand ready to assist others and are available for further discussion of these issues to shape the national agenda for patient safety. The most important feature of the APSF effort has been the elevation of patient safety to coequal status with more traditional concerns, such as determining the molecular mechanisms of anesthesia, developing specialized drugs, or managing critically ill patients. Our consistent emphasis has been on education and research. The primary vehicle for education has been a widely distributed, carefully crafted and readable newsletter, first distributed by mail to every practitioner and now available on the Internet (www.apsf.org) as well. The research has been driven by investigator initiated ideas and has been highly leveraged. We have accomplished a great deal with relatively few resources by fully supporting the efforts of others and choosing a cost-effective data sharing strategy. APSF has provided seed funding to investigators who in turn have spread patient safety thinking throughout the academic and practicing community. One important idea to emerge from APSF sponsored research has been the development of realistic simulators and educational programs for their use in training for anesthesia and other specialties. The APSF is in general agreement with the recommendations contained in the report of the Institute of Medicine (IOM) “To Err is Human.” We applaud the call for the establishment of a national Center for Patient Safety and urge that the Center be devoted to research inquiry and education only and that it not become involved in the politics of regulating or financing health care. We have serious concerns about the practicality, advisability and utility of the type of mandatory reporting of serious events recommended in the IOM report. Believing this recommendation to be premature and too specific, we suggest instead further study of existing mandatory systems to determine whether any form of mandatory reporting is desirable, and if so, what form it should take. We strongly endorse the recommendations for a voluntary reporting system and for enacting legislation to extend peer review protection to data related to patient safety. The two must go hand in hand. The APSF also has serious concerns about the call to develop methods to identify and take action against “unsafe providers.” While we agree that methods should be investigated for assessing the performance ability and competence of health care providers, this is not a simple matter and will require considerable research. And, while we strongly agree that other “professional societies should make a visible commitment to patient safety,” we suggest that each be given more flexibility about how to address their specific problems, rather than the very specific directives given in the report. While APSF supports the call for implementing practices to reduce medication errors, we caution that “proven” methods are not easily generalized and assumptions made on those generalizations could be counter-productive in settings other than those in which they were tested. APSF sees the practice of more complex surgery and invasive procedures in physician offices as a threat to safety because the offices are often completely unregulated. Several recent reports support this concern. We are currently considering encouraging the use of automated recording devices in all operating rooms similar to the “black box,” used in the aviation industry. In health care, safety must be a never-ending quest, particularly as efforts are made to control and reduce costs. We believe that the lessons learned by APSF have much to offer areas outside of anesthesia. A more detailed discussion of the APSF experience and our position on these issues is in the attached document. We look forward to applying our experience to the timely and necessary discussion about assuring patient safety.

Sincerely, Robert Stoelting, MD, President for the Anesthesia Patient Safety Foundation Executive Committee

Full Text Version

The recent report from the Institute of Medicine (IOM), “To Err Is Human,” recognizes the domain of anesthesia care as one of the only disciplines in health care that has taken effective actions to reduce medical error and improve patient safety. Indeed, the term “patient safety” was introduced into the medical lexicon in 1985 as part of the name of the organization several pioneers established to advance this cause: The Anesthesia Patient Safety Foundation (APSF). We are elated that the important issue of medical error and patient safety, a cause that APSF has championed for more than 15 years, is now receiving the serious national attention that it needs. Having set an example of success, we offer our advice and experience on how to create that kind of patient safety-oriented culture in other segments of the healthcare industry. The APSF Executive Committee is pleased to share what we believe to be the reasons for the success of this process. Our model has been focused, consistent and highly leveraged. That is, we have accomplished a great deal with relatively few resources by supporting the efforts of others and choosing a cost-effective dissemination strategy. It is a model that can and should be implemented by Federal agencies, by other medical specialties and allied professional groups, and by health care institutions and systems. It must be said, that while APSF has led the patient safety process in anesthesia, there have been many influences, independent and encouraged by our efforts, that have contributed to what are widely believed to be dramatic changes for the better. New and better drugs and patient monitoring technologies, improved training and safer equipment all contributed greatly to this process. Yet, we believe that trial and acceptance of these ideas was encouraged by the visibility that APSF brought to the issue of patient safety. Beyond providing this brief summary of the APSF experience, we are available to policy makers for further discussion of this national priority for patient safety. We have reviewed the recommendations in the IOM report. APSF is in general agreement with the IOM findings. We agree that medical error is a serious healthcare concern that must be addressed by the nation. Indeed, APSF was the first organization to recognize this, driven by the earliest research into human error in medicine. Seminal and widely cited studies of critical incidents in anesthesia identified the previously hidden problem of errors and helped to prompt the call for action. The concepts embodied in many of the IOM report recommendations, in fact, follow themes that have guided efforts of the APSF. However, we believe that some of the IOM recommendations need serious reconsideration and, in fact, if implemented, could be counterproductive to the progress made thus far. We are also concerned that the successes in the evolution of anesthesia practice as described in the IOM report may be construed to mean that anesthesia has completely solved all of its safety problems. While we are very proud of what we have helped to achieve for anesthesia patient safety, we believe there still remain unsafe practices and hazards that must be addressed. Indeed, we believe that several forces, including cost containment and production pressure, are acting to reverse the progress that has been hard-won during the last 15 years. The APSF Experience What does APSF do and what have been the roots of its success? APSF is a multidisciplinary 501(c) 3 corporation. Our Board of Directors includes representation from medicine, nursing, law, health care administration, and biomedical engineering as well as from the insurance, pharmaceutical, and medical technology/equipment industries. The concise mission statement of the APSF: “That no patient shall be harmed by anesthesia” should be extended to all of the areas of effort outlined in the IOM report. The philosophy of the APSF, which resonates throughout the IOM report, is that patient safety is a problem that should be treated in much the same way medicine approaches diagnosis, assessment and action. Suffering from disease or from medical error can be reduced by gathering data, conducting research, crafting and implementing interventions, as well as providing education to health care personnel and to patients and their families. These efforts will require involvement by Federal, State and local governments, by health care organizations, by professional societies and private foundations, and by the public. There is every reason to adopt missions and philosophies analogous to those of the APSF for the entire effort to promote safety throughout the health care system.

1. Education and dissemination about clinical problems and best practice solutions:

In support of the APSF mission, we have focused our efforts on education and research. We believe that the single most important impact of all that we do is to elevate discussion about patient safety to coequal status with more traditional concerns in the field. We did not have to regulate or set standards. We let others in their traditional roles do that. What we did so successfully was to motivate and support research and to offer information and a forum for debate about safety. We did this as a collaborative among the key stakeholders. We did it by being relentless in our message. We did not try to tell practitioners exactly what to do or how to do it. Rather, we motivated discussion via the APSF Newsletter, which is disseminated without charge to every anesthesia practitioner (both physicians and nurse anesthetists) in the U.S. and Canada (over 60,000 circulation – see the APSF Web site, (www.apsf.org), for current and past issues of the newsletter). We believe this vehicle has been very effective in illustrating the safety message. It has motivated changes in practices, in behaviors, and most importantly, in practice cultures that have been responsible cumulatively for a reduction in adverse outcomes. The topics covered in our newsletter have been chosen with careful deliberation about what to present to practicing clinicians. We have had many successes and a few failures in our objective to engage our colleagues in safety discussions, generating interest and synergy while avoiding conflicts that would be destructive. By carefully defining our audience and crafting the safety message, we have created a highly respected and very widely read publication. To those who are looking to do this in other arenas, we can offer consultation and guidance concerning elements that generated positive action. 2. Research: Similarly, the APSF research program has been highly leveraged. Since 1987, two to five research awards have been made each year. The current maximum award is $65,000 per grant with no more than three grants annually. A total of over $1.7 million has been spent on 45 projects. Reviews of the grant program have been published in the APSF Newsletter in 1994 and 1998 and can also be found at the APSF Web site. The research program has been operated primarily by volunteers and its administrative expenses are approximately 2% of the funds awarded. Yet, the result appears to have been highly effective. Once there was essentially little to no explicit discussion of patient safety at the annual meeting of the American Society of Anesthesiologists. Now, there are 50-100 abstracts presented in special sessions. There are more than 20 grant applications received by the APSF each year from investigators representing a wide spectrum of academic training programs, as well as other types of institutions. Those who were not funded by the Foundation have often identified other sources of funding for their important work. In this way the research program has created a thoughtful cadre of investigators and local leaders in patient safety. This concept for investigator-driven research was emulated by the National Patient Safety Foundation, which turned to the Chair of this APSF Committee to establish its own research program. Of the safety research topics that have been supported by APSF grants, those dealing with the development and use of patient simulation for training, education, and research have had the most visible impact. Indeed, the importance of simulation for safety improvement and error reduction was specifically mentioned in the IOM report. The essence of this activity, started with seed funding from the APSF, has now spread around the world and to many other health care applications well beyond anesthesiology. It is hard to imagine where the initial funding for simulation research would have come from if APSF had not been there to provide it. This experience suggests that the patient safety research and the Patient Safety Centers of Excellence called for in the IOM report should be implemented in a way that encourages investigator-driven research as opposed to relying on a program-driven RFP basis, since the former is more likely to remain free of political influence. 3. Barriers: APSF has had several other definite influences on safety in anesthesia, but those noted above form the primary basis for the impact we have achieved. One specific initiative, in which we were unable to make headway, does deserve mention. Over the years, we have considered seriously and repeatedly how to approach the idea of reporting and analyzing critical events in anesthesiology. This is one of the most difficult, controversial and important issues addressed in the IOM report. It is from our study and deliberations on this sensitive topic that we offer our opinions and, in some cases, challenge the recommendations of the IOM report.

APSF Comments on Specific Recommendations in the IOM Report Rather than responding to each recommendation point by point, we discuss only those that we think deserve specific commentary: RECOMMENDATION 4.1: Congress should create a Center for Patient Safety within the Agency for Health Care Policy and Research. The APSF applauds the call for the establishment of a Center for Patient Safety to be a NIH-like entity to fund research and development projects. Research funding via this Center will be an important vehicle for advancing knowledge and testing interventions to improve patient safety. As in the NIH model, this agency’s research support should compliment – not replace – those offered via other Federal agencies, by State and local governments, and through the private sector via foundations and health care institutions themselves. We strongly urge that the Center be devoted only to such research inquiry and consequent education and not itself become involved in the politics of regulating or financing health care. RECOMMENDATION 5.1: A nationwide mandatory reporting system should be established that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. While we recognize the desire and importance of accountability by practitioners for their actions, APSF has serious concerns about the practicality, advisability and utility of the type of mandatory reporting of serious events recommended in some detail in the IOM report. The report itself acknowledges that the issue is extremely complex. While it is true that some States now require some form of reporting, there is no evidence that it has resulted in any meaningful improvement in practice or patient outcome. Mandatory reporting systems in general create incentives for individuals and institutions to play a numbers game. If such reporting becomes linked to punitive action or inappropriate public disclosure, there is a high risk of driving reporting “underground” and of reinforcing the cultures of silence and blame that many believe are at the heart of the problems of medical error and patient safety. This would be particularly true to the extent that “innocent” providers could be unfairly accused. Health care is very different from other high-hazard industries (e.g. transportation, nuclear power or chemical production) in that all human beings will become ill and all will die. Nearly all of us will die in some proximity to medical care. The contribution of error, if any, to such events can be difficult to identify and disentangle, and the retrospective attribution of possible causation can be affected strongly by hindsight bias. We have further concerns about the nature of the bureaucracy that would be created to manage the aggregated reports from the States. In addition, there is the question of opportunity cost of such a program – could the funds and effort for this component achieve better results if used in a different way? Given the complexity and contentiousness of mandatory reporting and its uncertain effectiveness, is it wise to recommend at this time a specific program of mandatory reporting? Reasonable people and groups can and should debate these issues widely. Thus, APSF believes that IOM recommendation 5.1 is both premature and too specific in its content. A considerable amount of further study and public debate will be necessary to determine whether any form of mandatory reporting is desirable, and if so, what form it should take. RECOMMENDATION 5.2: The development of voluntary reporting efforts should be encouraged. The APSF strongly endorses this recommendation. APSF has been working toward this goal within anesthesiology for nearly a decade but has been stymied by the complexity of the attendant medical and legal issues. This makes recommendation 6.1 of particular interest to APSF. RECOMMENDATION 6.1: Congress should pass legislation to extend peer review protections to data related to patient safety and quality improvement that are collected and analyzed by health care organizations for internal use or shared with others solely for purposes of improving safety and quality. APSF most strongly endorses recommendation 6.1 and believes that such legislation will remove a fundamental barrier to improvements in patient safety. RECOMMENDATION 7.2: Performance standards and expectations for health professionals should focus greater attention on patient safety. · Health professional licensing bodies should (1) implement periodic reexaminations and re-licensing of doctors, nurses, and other key providers, based on both competence and knowledge of safety practices; and (2) work with certifying and credentialing organizations to develop more effective methods to identify unsafe providers and take action. While APSF agrees that health care workers should have appropriate competence and knowledge of safety practices, there is no known mechanism by which such characteristics can be measured readily. APSF also has serious concerns about the call to develop methods to identify and take action against “unsafe providers.” While APSF agrees that methods should be investigated for assessing the performance ability and competence of health care providers, this is not a simple matter and will require considerable research. Further, the concept of “unsafe provider” and what actions would be appropriate for such an individual are not clearly defined. Thus, these issues require further study before specific recommendations can be made concerning the assessment and regulation of individual clinicians. Professional societies should make a visible commitment to patient safety by establishing a permanent committee dedicated to safety improvement. APSF strongly supports the general thrust of this portion of recommendation 7.2. Although we agree with many of the activities suggested under this heading (e.g. information dissemination, including guidelines on safety in practice), we believe that the specific activities of any given professional society:

1) May not include every item on the list given; 2) Should probably include other activities that are not listed; and 3) Should differ in their mix from discipline to discipline within health care as appropriate.

As noted previously, one activity not mentioned on the list that has been important to the success of APSF is that of the professional society funding research on patient safety within a specific discipline. In anesthesiology, not only has this generated new knowledge and innovative ideas (e.g. patient simulation) it has generated a new cadre of investigators committed to studying patient safety issues. Therefore, it is important to recognize that the call for federal funding of patient safety research through the Agency for Healthcare Research and Quality will not eliminate the necessity of seed funding of such research by professional societies. RECOMMENDATION 8.2: Health care organizations should implement proven medication safety practices. In general APSF supports the call for the implementation of practices to reduce the likelihood of medication errors. We would caution, however, that determining the degree to which the efficacy of a specific practice is “proven” may not be easy. Also, the applicability of a specific “proven practice” may depend heavily on the context in which it is used. In particular, some practices (such as computerized drug order-entry or bar-code scanning of the patient name-band for each administration of a drug) that are proven to be useful in settings with low complexity and slow pace such as outpatient clinics or hospital wards may be inapplicable, counterproductive, or even dangerous if applied strictly in anesthesiology, intensive care units or other high complexity, highly dynamic domains of care. Rather than mandating specific techniques across the board, institutions should be encouraged to adopt techniques that have been proven successful in a specific arena of use. Remaining Safety Issues in Anesthesia What safety issues and concerns remain in anesthesia practice and how is APSF going about addressing them? It must be said that safety is a never-ending quest, particularly as efforts are made to control and then reduce the costs of health care. Almost every action in the spirit of reducing costs has some potential to create new unsafe conditions. Almost every new treatment and technology introduced to improve diagnosis and treatment of disease or improvement of the delivery system introduces new opportunity for error and system failure. The motto of the American Society of Anesthesiologists is “Vigilance.” Safety requires that al health care professions exercise vigilance in everything they do and in every change that they make to ensure safety for their patients. APSF has recently set its sights on a burgeoning concern about the safety of office-based procedures, particularly those in which anesthesia is administered. We see that moving complex procedures into office settings can be a clear and present threat to patient safety due to factors such as the lack of training of personnel, the absence of adequate monitoring and anesthesia delivery equipment, poorly constructed facilities, and the overall lack of accreditation, credentialing, regulation and oversight of activities in the physician office. We are embarking on several fronts to address these concerns and hope that those who will take a leadership role in the Federal and State governments will support those efforts. Beyond this, we will continue in our successful means of communications and research to identify issues large and small that threaten safety in anesthesia. We see the development of systems for incident reporting, data gathering, and event analysis as a fundamental need. One approach we plan to study is the feasibility of providing for anesthesia settings the equivalent of the aviation “black box” (flight data recorder) that has been so instrumental to the success of aviation safety over the past several decades. The technology to enable this function is now available, but collaboration between manufacturers, users and other stakeholders is needed to create a workable and effective system. APSF will work as it has in the past to create the dialogue and leadership that is needed. In Conclusion We welcome a dialogue between the leadership of APSF and those who will shape the implementation of the recommendations in the IOM report and other safety initiatives. Perhaps our experience would prove useful during this period of discussion and deliberation. Given our relatively long history of leadership in patient safety, we have much to offer. As befits our mission in anesthesia and our commitment to patient safety in all aspects of healthcare, it is our responsibility and our pleasure to do so.