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National Summit on Medical Errors and Patient Safety Research
American College of SurgeonsAdditional Statement, Submitted by Thomas R. Russell, MD, FACS, Executive Director, American College of Surgeons The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summit’s goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs. Selected applicants testified at the summit as members of the witness panels. The remainder of the applicants were invited to submit additional statements for consideration by the steering committee. One of these statements follows. Disclaimer and Copyright Statements Patient safety rests on a composite of factors within the totality of the health care system. In surgery and its specialties, safety relies on the presence of competent and informed surgeons, a "safe" institution, and on systems of good practices with which the surgical care is rendered. Therefore, patient safety is obviously of great importance to the surgical community. Many hospitalized patients enter specifically for a surgical procedure or are subsequently diagnosed after admission with a problem requiring surgical intervention. Errors, near misses, and variations in outcome from surgeon to surgeon and institution to institution, are present in our existing medical system. The operating room is a high-risk area of all hospitals but patient safety issues in surgery are not confined to the operating room. Safety issues are also relevant in emergency departments, recovery rooms, surgical intensive care units, patient care units, and in ambulatory surgery centers, the surgeon's office, and other outpatient facilities. The American College of Surgeons was formed in 1913 to "...elevate the standard of surgery...and to formulate a plan which will indicate to the public and the profession that the surgeon...is especially qualified to practice surgery..."1 The College has a longstanding interest in patient safety issues, and we are now considering innovative ways to enhance patient safety. We believe that the agencies represented on the Quality Interagency Coordination Task Force (QuIC) can facilitate our efforts, and we are pleased to have this opportunity to present testimony for the National Summit on Medical Errors and Patient Safety Research. This statement begins by briefly reviewing the College's longstanding involvement in patient safety issues, summarizes our recommendations relating to needed patient safety research, and goes on to discuss each of our recommendations in more detail. ACS Involvement in Patient Safety The American College of Surgeons (ACS), with more than 60,000 members and representing all surgical specialties, has been concerned with patient safety since its founding in 1913. For example, in 1918, the College initiated a Hospital Standardization Program in an effort to ensure a safe environment and an effective system of care for surgical and other hospitalized patients. That program ultimately led to the establishment of what is known today as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). This commitment continues through the College's representation on the JCAHO board, as well as through other programs and initiatives conducted by a number of College committees and departments. 1. Informed and Competent Surgeons and Informed Patients The College has been intimately involved in the education of surgeons at the undergraduate, graduate and continuing medical education levels. For example, the College's Committee on Emerging Surgical Technology and Education studies the implications of innovations in surgical methods and develops policies to promote appropriate training for surgeons and protect the welfare of the surgical patient. The College also sponsors a wide variety of courses and educational activities, specifically including those aimed at assuring the safe and effective dissemination of new technologies, such as stereotactic breast biopsy, diagnostic breast ultrasound, and sentinel node biopsy in the management of breast tumors. A program administered by the College's Committee on Continuing Education helps surgeons stay abreast of current practice standards. This program, the Surgical Education and Self-Assessment Program (SESAP), provides the opportunity to test personal knowledge of the current standards in surgical practice by reproducing the diagnostic and treatment challenges faced in the practice of surgery, and obtain immediate feedback for self-improvement. The College is presently engaged in a collaborative effort with surgical certifying boards to develop skills-and outcomes-based assessments of practicing surgeons using a variety of tools, including the possible use of surgical simulation. The College has also established standards for CME and will evaluate and accredit programs in continuing education for surgeons submitted by recognized surgical organizations, under the aegis of the Accreditation Council for Continuing Medical Education (ACCME). Maintenance of certification, as described by the American Board of Medical Specialties (ABMS) is supported by these activities. To educate patients about surgical issues, the College has long supported an active public information program, including brochures on what distinguishes surgeons from other physicians, what to look for in examining a surgeon's credentials, questions to ask before consenting to an operation, and web-based patient information materials. These materials and College Fellowship as a criterion to assess a surgeon's qualifications, are quoted by the Agendy for Healthcare Research and Quality (AHRQ) in its web-based patient guides. 2. Safe Institutions The College has published a Patient Safety Manual as a guide for implementing a systematic approach to quality assurance and risk management in hospitals. The manual focuses on a systems approach to patient safety that includes: analyzing quality of care data; peer evaluation of data; determination of corrective action; and, communicating the results to all affected parties. The College's Committee on Patient Safety and Professional Liability is developing and will disseminate additional patient safety-related publications to assist the surgical community.3. Systems Development The College pioneered the development of a systems approach for trauma; its Advanced Trauma Life Support (ATLS) educational program is now the world-wide standard for providers of trauma care. The College's "Resources for Optimal Care of the Injured Patient," establishes the basis for trauma center designation in North America. The successful and life-saving systems approach adopted for initial care of the injured patient, provides a model for the development of other "critical pathways" in the care of all surgical patients. The College maintains large data bases of patients who are victims of trauma (National TRACS) or cancer (the National Cancer Data Base), which are regularly queried to determine patterns, expected outcomes and variations, and best clinical practices. As an example, we have recently documented through our cancer registry and data bank a decrease in survival following breast cancer surgery in those patients treated in low-volume hospitals (less than 25 cases per year) compared to high-volume hospitals.2 Recognizing that much of surgical practice has not been evidence based, especially during the introduction of new surgical technology, in 1994 the College initiated a program to develop and implement clinical trials. The first trials, to assess watchful waiting, open operation, and laparoscopic hernia repairs, are in process, funded by the AHRQ and VA Cooperative Studies Program. Subsequently, the College began a new clinical trials program in cancer, funded by the National Cancer Institute (NCI); presently, 8 trials related to surgical aspects of cancer management, are open and accruing patients. The purpose of the clinical trials program is to test safety and efficacy of new surgical procedures before they are widely disseminated into practice, develop educational programs for surgeons to assist them to introduce the new technology safely into their practices, and to critically evaluate current practices. In short, for the last 87 years, through the programs and initiatives outlined above and other efforts, the College has consistently emphasized patient safety and quality of care. At this point, however, best methods for ascertaining competence, continuing education of the practicing surgeon, and the development of systems of good practices using principles of evidence based medicine, remain to be devised, tested, and implemented. Summary of ACS Recommendations The American College of Surgeons recommends that research be carried out in the following areas:
Each of these recommendations is discussed in more detail below. As the umbrella group for all of surgery, the College believes that it can play a key role in advancing knowledge in each of these areas, and we are committed to working with all interested parties, including QuIC agencies, toward that end. Surgeon Competence Surgeon competency is one important component of the patient safety equation. The College is presently engaged in a collaborative effort with surgical certifying boards to develop skills- and outcomes-based assessments of practicing surgeons using a variety of tools. All of this flows from work begun by the American Board of Medical Specialties(ABMS), the umbrella organization for 24 member boards, and is predicated on the belief that recertification of board-certified physicians is not sufficient to declare that a physician is competent. Thus, the ABMS Task Force on Competence, chaired by a Regent of the ACS, has developed the concept of maintenance of certification, whereby physician diplomates of the various specialty boards would be required to demonstrate their performance against competencies set forth by the ABMS and its member boards. This Task Force has produced a description of the competent physician, and six general competencies against which physicians should be evaluated (patient care, medical knowledge, practice-based learning and improvement, interpersonal and communications skills, professionalism, and systems-based practice). For each of these competencies, the Task Force has identified example components. For instance, in the case of practice-based learning and improvement, one example component involves demonstrating continuous practice improvement by: (1) Engaging in lifelong learning to improve knowledge, skills and practice performance; (2) analyzing one's practice experience to recognize one's strengths, deficiencies and limits in knowledge and expertise; (3) using evaluations of performance provided by peers, patients, superiors and subordinates to improve practice; and (4) seeking ways to improve patient care quality. The optimum educational methodology to maintain knowledge and skills, and to assess competence in any of the components identified above, has not been developed or tested. Measurement of competence is not reliable given current capabilities and tools. Skills assessment is especially difficult. Introduction of New Surgical Technology In addition to the generic issue of physician competence, an important consequence of the continuing evolution of health care technology is that surgeons are increasingly finding it necessary to acquire new surgical skills after completion of their formal surgical residency training program, sometimes many years later. This means that these surgeons must participate in high quality continuing medical education programs that focus on acquisition of new information and new skills. Surgeons must have access to sound mechanisms for learning and applying new technical skills. Further, after a surgeon has completed such a learning experience, effective and efficient mechanisms are needed to assess a surgeon's competence to perform a new surgical procedure before applying it to patients. Research is needed to develop and test continuing medical education programs and methods for assessing surgical competency. The College believes that resources must be devoted to the development of surgical simulators. To a large degree, such simulators would serve essentially the same roles as those used by the nation's pilots and pilots-in-training. The College believes that the timely development of surgical simulators and related tools will require the infusion of government resources because of the high costs involved. Systems Development Based on Surgical Best Practices System improvements for safety of the surgical patient are complex and have been largely neglected. Notable exceptions include work by the Anesthesia Patient Safety Foundation and the "Sign Your Site" program by the American Academy of Orthopaedic Surgeons. Recent studies correlating improved patient outcomes in surgical procedures performed in high volume centers,3,4 may provide information relevant to the importance of systems development in care of the surgical patient. The Journal of the American College of Surgeons has published (or will publish) a number of such studies within the past year,2,5 including an analysis of breast cancer survival in institutions with low (less than 25 patients treated annually) or high (greater than 25 patients) volume of breast cancer patients. The relationship between volume and outcomes is not well understood. For some procedures, no such relationship has been observed or studies have produced conflicting results. Further, in some cases, the relationship between volume and outcomes relates to facility-wide experience with a given procedure, rather than being solely a function of a given surgeon's experience. In other words, even low volume surgeons in high volume hospitals appear to have comparable results to surgeons with more experience. In addition, even when a relationship between volume and outcomes has been documented, it is still true that good outcomes are seen in some low volume institutions, while relatively poorer outcomes are seen in some high volume facilities. In short, much more work is needed to understand the contribution of physician and facility service volumes to patient outcomes. This is especially true given the fact that policy makers might be tempted to use the findings of studies such as those discussed above as a rationale for restricting certain procedures to high volume facilities or for providing incentives to encourage the performance of procedures in such sites. In the absence of further research to understand the relationship between volume and outcomes, the College believes that such policies would be inappropriate, especially given the impact such policies would have on patients (e.g., the need to travel further from home to receive necessary care). In short, the College believes that studies of systems of care in high and low volume hospitals have the potential to improve the overall quality of care of the surgical patient, and the College urges AHRQ and other agencies represented on the Quality Interagency Coordination Task Force to support such research efforts. In this regard, the College would, for example, be pleased to conduct a more in-depth analysis of high volume centers, including site visits, to try to determine the reasons for the observed volume-related effect on breast cancer patient outcomes. In addition to the volume-outcome work, the College also believes it would be important to assess whether the experience of the National Surgical Quality Improvement Program (NSQIP) of the Veterans Health Administration (VHA) can be generalized to non-VHA institutions. The NSQIP was an outgrowth of an earlier National VA Surgical Risk Study (NVASRS). The program was established to provide accurate and useful comparative data about surgical outcomes among all the Veterans hospitals performing major surgery and to compare the outcomes in the VHA with those in the private sector. Under this program, prospectively collected patient risk factors, important intraoperative process information, and postoperative mortality, morbidity and length of stay data are collected on thousands of operations each year.6 Information developed through the NSQIP is risk adjusted and fed back to practicing surgeons and other hospital staff, with concomitant observed reductions in postoperative mortality and morbidity.7 In this regard, it is important to emphasize that the project stresses improvements in patient care, rather than sanctions or blame. Testing a NSQIP-like program in non-VHA facilities would entail using risk-adjusted data to assess the outcomes of patient care in various facilities providing surgical care, and developing the means to feed back outcomes data to clinicians and other health care personnel with recommendations for improving performance. Best Practices: Critical Pathways for Common Surgical Procedures It has been repeatedly documented that there are significant geographic and other variations in the ways patients are managed, even for relatively common ailments. In some cases, it is clear that this variation is appropriate. In other cases, however, it is less clear that the variations are warranted. Interestingly, a study sponsored by the Health Services Research and Development Service of the Veterans Health Administration found that centers with the lowest risk-adjusted postoperative morbidity and mortality rates made greater use of clinical pathways and protocols. In fact, these centers tended to make pathway development a much higher priority than did centers with poorer surgical outcomes. The College believes it would be important to assess whether the use of "critical pathways" improves outcomes for surgical patients. We believe that this could be tested for common procedures performed by each of the major surgical specialties. An obvious step would be to develop consensus for critical pathway management for such procedures. The College is the obvious vehicle to develop and disseminate best practices. Addressing Areas of Error Avoidance in Surgery In addition to all of the above, the College believes that an effort should be made to identify and prioritize surgery-related issues affecting patient safety. For this purpose, we believe that a panel of surgeons representing all the major surgical specialties should be assembled and, as the umbrella group for surgery, the College would be pleased to serve as a convener. The goal of the panel's work would be to identify issues that warrant immediate investigation and study because of an important bearing on the care received by large numbers of patients, such as the safe positioning of patients undergoing various procedures to avoid damaging nerves or otherwise causing patient harm. Once a prioritized list of issues has been carefully delineated, the next step would be to determine the most effective and efficient means for providing needed guidance to clinician and to test the effectiveness of these measures. Evidence-Based Surgery Most of what surgeons do is based on common practices, rarely tested in the rigor of a controlled clinical trial. Even many established surgical treatments, such as hernia repair, have not been tested against non-operative management (watchful waiting). New procedures must be scrutinized and evidence developed that the procedure is safe and effective before it is disseminated into practice; before dissemination, education and assessment tools must be developed to provide the practicing surgeon the knowledge and skills needed to apply the technique safely. Support of clinical trials in surgery should be encouraged and surgeons must be stimulated to require evidence, and to acquire comprehensive knowledge and skills before adopting a technique into their practices. Conclusion The American College of Surgeons is firmly committed to enhancing patient safety as should be evident from its longstanding efforts in this area. We are grateful to have this opportunity to outline the additional research that we believe is needed to address patient safety issues affecting patients requiring an operation. We look forward to collaborating with QuIC agencies on high priority patient safety initiatives and we would be pleased to try to provide any additional information that may be required. Top of PageReference List Top of PageCurrent as of September 2000 Internet Citation: American College of Surgeons. Additional Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/aacs.htm Return to Additional Statement Directory |