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American College of SurgeonsClinical CongressMonday, October 26, 1998 Life After Residency: Acquiring, Documenting,
and Defending New Surgical Skills Introduction Technique-Based CME Courses Challenges, Opportunities,
and National Guidelines Hospital Exposure Technical Skills, Evaluation, and Measurement Liability and Other Legal Issues in CME Introduction Emergent technology offers creative solutions to management diagnosis and treatment of the surgical ills of today. These creative solutions must be translated by various methods of practical application and, ultimately, better outcomes for patients with these problems. Laparoscopic techniques, laser application, image-guided biopsy, telemedicine, specialty instrumentation and implants and new techniques of all types are current ongoing areas of emergent technology. The practical application of this emergent technology by the surgeon requires not only commitment on the part of the surgeon, but also equal commitment by the people, the organizations, and the process that make that technology available. The world of continuing medical education (CME) is complex. The at times stifling array of marketed sponsors, marketing mediums, individuals and approaches to educating the practicing surgeon to new skills, ideas, and techniques demands a very high level of choice making by that surgeon. This choice making can be determined by institutional or organizational allegiance, by vendor marketing, peer usage, and through hospital orientation. The more mundane attractions of weather, resort atmosphere, proximity, available dates, etc. all influence CME delivery. The surgeon, after deciding on a certain specific educational objective must then implement that new technology into his or her practice by meeting various and varying standards and/or requirements. These requirements reflect the quality of the educational effort. Nowadays forces in medicine and surgery increasingly require quantification of that quality. It is to that objective that this Panel Discussion is oriented. It is clear that inherent risks increasingly affect the education vehicles as well as the hospital, the credentialing medical staff mechanisms, and the surgeons. So the surgeon must not only acquire the skills but document that acquisition. That documentation is evolving in the CME offerings of the American College of Surgeons in numerous areas and in a number of ways both administratively and scientifically. [The further issues of the establishment of specific clinical guidelines and cost allowances for our application of this new technology is beyond this discussion.] Dr. Bellande will present an overview of technique based CME as provided by the various procedural specialties. What is the delivery system? How about telemedicine application? Who sets the standards? What is the vision for the next millennium? Dr. Fletcher will look at CME and credentialing issues regarding new technology and its ramifications at the hospital level. What CME certificates should suffice? How are these certificates used at the local level? Is outside participation in the credentialing process appropriate? What place does CME overall play in the credentialing process? Dr. Reznick will point up current evolving tools to interlock the teaching, and the evaluation and measurements of the students. What specific documentation or certificates can be taken back home? How does this documentation or certificate relate to overall proficiency of the surgeon? Does the proficiency stand statistical analysis? How far along are we in that process and what is the process? Finally, Mr. Jacobs will examine the very real liability issues that surface at every point along the chain from technology development to technology usage at the bedside or in the operating room. Is the new technology ready for CME? Is it ready for acceptance back home? Should it be rejected? What is the sponsor risk? What is the definition of acceptable risk for all parties? We hope you enjoy the symposium. Please prepare any questions you may have for discussion. Thank you. Technique-Based CME Courses Challenges,
Opportunities, and National Guidelines Challenges The ultimate purpose of CME is to have a beneficial impact on the competence of physicians, leading to improvements in the quality, efficacy and cost-effectiveness of health care services. With regard to postgraduate continuing medical education (CME) opportunities, an assessment must be made of the relevance and impact of specific CME programs to the physician's practice, especially when evidence of attendance or successful completion is utilized in making reappointment and reprivileging decisions. While providers of CME customarily furnish evidence of attendance and the number of hours awarded to physicians for their participation in CME activities, they have staunchly resisted certifying competency as a result of physicians' completing CME courses or programs. The primary reasons for such resistance are the paucity of definitive evidence that CME changes physician behavior or enhances practice performance and the legal liability placed on the educational provider in certifying competence. As a consequence, there is a need to clarify the requirements for credentialing, to reemphasize the purpose of those requirements and to enunciate a set of principles or criteria that would be useful to privileging authorities for evaluating verification. Opportunities National Guidelines In 1997 The American Medical Association issued new educational standards for training to acquire new clinical skills. The acquisition of skills training may be through (1) specific formal courses, (2) a clinical preceptorship, or (3) both. Formal Courses Levels: A system of descriptive levels for education and training courses in procedural skills to be used by accredited sponsors and identified to the potential participant in advance. Level 1—Verification of Attendance: the physician attended and completed the course. Level 2—Verification of Satisfactory Completion of Course Objectives: The physician satisfactorily met all specified learning objectives. Level 3—Verification of "Proctor Readiness": The physician is "proctor ready," which includes Levels 1 and 2, and the physician is able to perform the procedure under proctor supervision. Level 4—Verification of Physician Competence to Perform the Procedure: The physician is competent to perform the procedure without further supervision. Each accredited sponsor, in collaboration with its faculty, will have the responsibility for determining and incorporating the specific educational and training requirements established in each specialty. Each sponsor must identify expert faculty who will bring with them the knowledge and latest recommendations in a procedural area for the specialty most familiar with the procedure, and the faculty in turn will adapt this material to the specific needs of the training course and the changing technology. The accredited educational institutions must have adequate resources, including the facilities necessary to conduct and assess the achievement of the educational objectives by the participants. It is likewise incumbent on these accredited sponsors to choose only faculty to teach these activities who have the demonstrated ability, knowledge, and expertise in the area being taught . Clinical Preceptorship Documentation stating that the procedures were satisfactorily performed must be provided to the preceptee. This information may be provided, upon written request, to a credentials committee of a health care organization. A log of activities kept by the trainee and reviewed by the preceptor and/or credentialing body could assist in the privileging process. Sponsoring institutions must maintain permanent records of preceptees in order to make these available to appropriate authority bodies on request. A certificate of continuing medical education credit may be provided by the sponsoring organization, if appropriate. Bibliography Buck AS, Schyve P: Credentialing and privileging: A current perspective. Fed Bull 1998; 85(1): 30 34. Buck AS, Croteau RJ, Van Ostenberg P, Schyve PM: Evaluating agencies that verify practitioner credentials The Joint Commission perspective. Fed Bull 1996; 83(1): 30 39. Report on licensure of physicians enrolled in postgraduate training programs. Fed Bull 1996; 83(3): 163 169. Study of the need for mandating continuing medical education. Fed Bull 1997; 84(1): 26 46. Hospital Exposure The underpinning for the concerns by hospitals and physicians about the process of credentialing surgeons in new technologies is the doctrine of corporate negligence set forth in the landmark 1965 decision of Darling v. Charleston Community Hospital. Since then, there have been several cases in which the courts have held the hospital liable for corporate negligence for failing to exercise reasonable care in the selection, the supervision and the review of competency of each medical staff member's past and present clinical activities. The theory of corporate liability permits a hospital to be held liable for physician malpractice if the hospital knows or should have known that the physician was incompetent or was likely to perform negligently. As a result of the doctrine of corporate negligence, the rapid development of new technologies and the emergence of many for-profit courses, a series of questions have been raised by physicians, medical specialty organizations, executive committees, hospital boards, corporate attorneys, and malpractice lawyers about the best methods to insure the best care for the patients. Examples of the questions are as follows: What is the purpose of the new technology? Is the new technology safe and effective, proven in clinical trials to enhance the care of the patient and be cost effective? What is the learning curve for the surgeon? What are the requirements and quality of the courses? What type of proctoring will be needed? Who will set the standards? What are the risks to the hospital? What should be the certification process? The process of granting privileges for physicians has become
a very time consuming process in part because of the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO). The JCAHO
requires hospital and other credentialing bodies to verify the
documents physicians provide to hospitals for privileges, verification
of competency by peers (letters), verification of previous credentials,
and certification of competency by the department in which the
privileges will be practiced. In addition to the process of the
initial credentialing, there is the emerging evolution of quality
assurance, quality improvement, total quality improvement and
malpractice issues. Needless to say, these areas have increased
the awareness of all providers of healthcare to concerns related
to privileges, credentialing, continuing medical education, and
recertification. It is imperative for program directors in surgical
disciplines to document the experience the resident has in many
areas, but especially in the care of the critically ill, procedures
related to endoscopy and laparoscopy. The lack of adequate documentation
may preclude the physicians ability to The American College of Surgeons (ACS) established the Committee on Emerging Surgical Technologies to develop a rational approach to the problem. The CESTE has published "Guidelines for the Evaluation of Credentials of Individuals for the Purpose of Awarding Surgical Privileges in New Technologies." A statement on emerging surgical technologies and the guidelines can be found in the June 1994 issue of the Bulletin of the American College of Surgeons. The essence of both the statement and the guidelines relate to the highest principles of both education and clinical care. The guidelines embrace the tenets of continuing medical education, namely the requirements for the identification of the target audience(participant), the global objectives, the specific objectives, evaluation and verification of both cognitive and technical skills, and follow up of outcomes related to the particular skill. As recently as October 1997, the ACS Board of Regents approved a process by which new courses in emerging technology must be evaluated before the course can be accepted or endorsed by the College. The documentation to be provided by the course director of for courses sponsored by the ACS is as follows: Level 1: Verification of attendance; Level 2: Verification of satisfactory completion of course objectives; Level 3: Instructor level. These verifications insure the reviewer of these courses that the surgeon has attended and completed a course, has satisfactorily met the specified learning objectives, and has had monitored practice experience with the technology and has documented satisfactory patient outcomes; the surgeon has participated in development of goals and objectives for educational programs in the technology and is experienced in teaching these skills to others. Clearly, the ACS has been sensitive to the issues of education and credentialing for the past 20 years in order to teach new skills to the practicing surgeon. In order for hospitals to improve their methods for credentialing surgeons and others in new technologies the following suggestions are excerpted from Health Care Risk Control (vol 3, ECRI, January 1996):
The adherence to the principles of quality of care embodied with the tenets of education, verification, documentation, evaluation, and quality improvement will continue to decrease the risk to the patient, and the hospital to the concerns of credentialing physicians in emerging new technologies in future years. Technical Skills, Evaluation, and Measurement This talk will focus on the results of research done by the Surgical Education Research group at the University of Toronto. Our desire has been to develop a method of assessment in the realm of technical skill. The dual purpose of this effort is to construct a method of assessment that can be used for residency and to develop methods that are applicable to continuing education efforts such acquiring new technical skills. In this quest for objectifying measures of technical competence our group has analyzed the reliability and validity of a new instrument called an Objective Structured Assessment of Technical Skills (OSATS). The OSATS is an OSCE like examination which is performance based. We have used two platforms, a bench and a live platform. We have also looked the efficacy of two scoring systems namely a global rating form and a task specific checklist. The examination is blueprinted from the objectives of technical training for general surgical trainees in Canada. The initial experiment had as a principle focus the head on head comparison of the live versus the bench models. Residents served as their own controls and took both forms of the examination. Therefore if they did a small bowel resection and anastomosis on lyophilized intestine they also did one on the live animal model. The results showed that the two forms of the examination were equivalent. There was no systematic difference between the live animal model version and the bench model version. This was important to us as it allowed us to proceed with confidence that bench model simulations are an appropriate method of testing technical competence. We have now run three iterations of the OSATS testing approximately 50 residents each year. Reliability estimates have been excellent ranging from .80 to .89. The OSATS has been shown to be construct valid in that there is systematic growth at all levels of training. From these data we have been able to plot growth curves of how a typical resident should ascend in their technical competence through a training program. We have developed a criterion measure to analyze the concurrent validity of this new examination. Because there is no gold standard of technical competence what we did is used a forced choice ranking method to solicit faculty's opinions about individual pairs of residents. Through an iterative process we developed a rank ordering of resident's competence in the technical domain and compared those results with the resident's results on the OSATS. What we found was that on this new measure of ranking, the faculty were very internally consistent with their ratings. There was also a high degree of consistency with the OSATS. We also examined the two methods we have used for scoring namely the task specific checklist and the global rating form. We did this during one iteration of the OSATS with a head on head on comparison of these two methods. We found that the global rating form outperformed the checklist in every dimension we studied. It appeared to be a more reliable form of assessment. It also appeared to account for a greater proportion of the variance of the scores when analyzed in a regression analysis. Recently we have been working on analyzing the efficacy of a new form of technical skill measurement, namely product analysis. We questioned whether one could make a judgment about the technical competence of a resident who performed an operation by simply analyzing the end product. We therefore, during the context of an OSATS examination, sequestered the end products and had them separately analyzed by a group of examiners. We developed a product analysis score and found that this correlated moderately with the process scores as measured by the OSATS. Product analysis alone accounted for almost half of the variance of predictability of PGY status. In summary, over the last four years our group has developed a new form of technical skill assessment that we feel shows promise in objectifying the measurement of technical competence. It appears to have a level of reliability that enables us to interpret the scores with confidence. We have been able to plot standards for levels of performance for different levels of trainees. We have developed a new method of assessing technical competence using faculty's opinions and there is high concordance between that and our OSATS examination. We have looked at the issue of global rating forms which are highly structured versus task specific checklists and have found that the global rating forms have outperformed the checklists in all dimensions. Lastly, we are exploring a new method of testing technical competence, namely analyzing the end product. We are hopeful that the development of reliable and valid assessment for measures of technical competence will aid us in certifying competence in technical skills at the graduating specialist level. Perhaps, more importantly it may equip us with a tool which we can use for certifying competence in acquiring new technologies and for conducting ongoing assessment of maintenance of competence. Liability and Other Legal Issues in CME Continuing medical education courses and materials provide an invaluable mechanism for informing physicians about new technologies and techniques. For many physicians, this is the primary means of keeping up with new discoveries and treatments. Recognizing this intrinsic value, the law generally affords significant deference to medical educational activities, through First Amendment protections and other legal defenses. Nonetheless, the CME process still carries legal risks for CME providers, sponsors, and participants. As a threshold matter, CME can both reduce and, in some cases, increase the risk of malpractice liability for physicians who choose to employ new procedures or techniques using new technologies. On the one hand, attendance at CME events can demonstrate proficiency and compliance with evolving standards of care, thereby reducing the risk of malpractice liability. On the other hand, attendance at a few CME courses may give a false sense of proficiency that could lead to the performance of procedures by physicians without sufficient training, thus increasing liability risk. It is also conceivable that a CME sponsor could be held liable for negligently certifying an unqualified physician or for disseminating information that is inconsistent with the relevant standard of care. Recent litigation challenging the use of the CME process to promote the "off-label" use of the pedicle bone screw for spinal fusion surgery provides a telling and painful example of new and emerging legal risks associated with continuing medical education. Those cases demonstrate that CME providers, sponsors, and physician faculty are at risk of being dragged into massive products liability litigation based on the failure to disclose industry sponsorship or the off-label status of products discussed at CME events. While these cases appear to be heading for a happy ending, the path along the way has been excruciatingly time consuming and expensive. In addition to liability risk, CME providers and industry-sponsors must be cognizant of guidelines issued by the Food and Drug Administration restricting industry-sponsored scientific and educational activities that involve the promotion of off-label uses of approved drugs and devices. Although a district court in Washington, D.C. has recently limited the reach of the FDA's guidance documents, their impact on the CME process will still be felt by CME providers and industry sponsors. CME participants and providers should also be aware of copyright and other intellectual property issues relating to presentations and enduring materials. Many CME providers would be surprised to learn that, in the absence of an explicit assignment or license arrangement, physician faculty members retain copyright ownership of the works they present at CME sessions. This means that CME providers may not be able to sell video or audio tapes or conference handouts without permission from faculty members. Conversely, faculty members must have permission to use materials borrowed from other sources (for example, photographs, videotapes, and so on) to avoid liability to third-party copyright holders. CME providers or faculty can also inadvertently violate the rights of patent holders if they promote infringing drugs or technologies. A similar, more troubling risk applies to the promotion of medical or surgical procedures that have been patented. Not long ago, a patent infringement case was brought by the physician who claimed to "own" no-stitch cataract surgery; the was unsuccessful and motivated Congress to adopt legislation to prevent similar lawsuits against physicians in the future. Lastly, CME providers and faculty must be aware of the need for appropriate releases and consents from patients involved in demonstrations, whether live, on videotape, through photographic depictions, or otherwise. Such consents must not only provide permission to perform medical procedures, they should relinquish any rights the patient may have to compensation as well. Online March 17, 1999
by the American College of Surgeons, Chicago, IL 60611-3211 |