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 Summary
The 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.
APSF Comments on Specific Recommendations in the IOM Report
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.