American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (AAOS), representing more than 16,000 Board certified orthopaedic surgeons, has been a leader among the medical societies in implementing programs to assist physicians and other medical personnel to prevent medical errors. We have undertaken the following major initiatives with the goal of ensuring patient safety:

• More than a decade ago, the AAOS Board of Directors committed significant financial and clinical resources to develop clinical practice guidelines that focus on safe patient care to be used as educational tools to guide physicians through diagnostic and treatment decisions.
• Since 1990, the AAOS Committee on Professional Liability has conducted a series of closed-claim professional liability insurance studies, through on-site retrospective review of the records of insurance companies to determine common causes of orthopaedic error. This work resulted in the publication of several articles and the first and second editions of Managing Orthopaedic Malpractice Risk.
• In September 1997, AAOS created a task force to examine surgical errors and recommend prevention safeguards for the operating room, ultimately resulting in the development of a "Sign Your Site" protocol to eliminate wrong-site surgery. This program has been adopted by surgeons and hospitals throughout the country. We have provided information on the protocol at the request of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and the Agency for Healthcare Research and Quality (AHRQ) has highlighted this program in their medical error information to patients.

The AAOS believes that policies directed at patient safety and medical errors must first determine, by supporting research, whether and how existing voluntary and mandatory reporting systems and prevention initiatives have led to a reduction in medical errors. Without clear direction on how to integrate the results of these initiatives broadly across the health care system, AHRQ risks prematurely raising expectations that such programs do lead to a reduction in medical errors. It is disconcerting that, while approximately one-third of the states have implemented mandatory adverse event reporting systems, there is no indication that these systems have resulted in safer environments for patients, and that the data has not been utilized to assist in reducing medical errors.

We believe strongly that no medical error reporting system should be implemented unless and until the system is prepared to follow through on using the data constructively to assist providers in redesigning systems and processes to reduce the risk of errors. The data can be used to establish or clarify appropriate treatment protocols and methods of operation, as well as acceptable protocols on how to proceed once discovery of an error has been made. As part of the follow-through, it is important to determine if there is reasonable scientific evidence to indicate that system changes implemented as a result of root cause analysis reduces medical errors.

The AAOS encourages AHRQ to partner with private entities in an effort to develop better and safer health care delivery systems. Data from the aeronautics industry and the anesthesiology profession demonstrate that redesigning the systems is key to reducing errors. The AAOS has undertaken important first steps through the implementation of several prevention initiatives, such as the closed-claim studies and the "Sign Your Site" campaign. We are now encouraging AHRQ to study these initiatives to determine their success and validity in ensuring safer practices and in reducing the number of medical errors.

The closed-claim studies involved the review of malpractice cases, successful and unsuccessful, relating to almost every facet of orthopaedic surgery. We believe that there is a lesson to be learned from every claim. For the most part, these lessons fall into two broad categories: general principles and specific causes, applicable to certain diagnoses, operations or clinical situations. Generally, applicable lessons included issues regarding informed consent, failures/delays in diagnosis, complications under casts, other preoperative and postoperative complications, medical record documentation, wrong-site surgery, consultation responsibilities and the scope of post-operative care.

Lessons applicable to specific circumstances included such issues as recognizing that wrong level spine surgery still occurs frequently enough to show that existing procedures to identify the level are not failsafe. Review of the claims also revealed the most commonly missed diagnoses by age range of patients requiring more meticulous evaluation. Feedback involved suggestions and general principles to help surgeons provide the highest possible quality care and clinical outcomes to patients.

We believe these initiatives can offer valuable insight into health care system processes, including: what information is critical to report and how information should be reported; appropriate procedures for presenting information to patients and securing informed consent; the appropriate scope of preoperative examinations; the range of medical personnel critical to the process and what information they need to access; medical record documentation; and the use of medical charts and information.

In launching our "Sign Your Site" campaign, we have discovered that such efforts require long-term commitments and resources. From our experience, we would caution you that policies cannot underestimate the planning involved. A comprehensive campaign requires intensive ongoing communication, networking, surveying, monitoring, research, feedback and education. Resources required to redesign systems based on research findings need to be considered.

Determining what information physicians and medical personnel need to know to assist them in preventing medical errors raises the question of standardization of data. When standardizing the data, both for reporting medical errors and for providing feedback on specific medical error findings, variability across medical professions needs to be considered. Relevant and/or useful information and medical terminology may vary among medical specialties and across medical personnel.

Medical error reporting systems need to take into account treatment protocols unique to specialties. For example, closed-claim studies on spine surgery show that treatment protocols in spine surgery vary widely among practitioners and that there are built-in biases, depending on experience and training. Feedback from the study of closed-claims advises surgeons to be aware of various algorithms on low back pain and use them as a guide for surgical decisions and to be familiar with a broad spectrum of treatment choices, indications, and confirmatory tests that cause them to recommend a particular course of treatment. They are advised to carefully document deviations from treatment protocol.

Medical error reporting and feedback processes need to identify specifically the range of medical and paramedical disciplines involved in providing care to patients. Medical error reporting requirements need to clarify who is responsible, permitted, or obligated to report on a medical error incident. If more than one member of the medical team reports the same medical error incident, is this then considered or recorded as one event or more, depending on the number of individuals who file a report? The institutional protocols recommended by AAOS' "Sign Your Site" campaign involve operating room nurses and technicians, hospital room committees, anesthesiologists, residents, and other preoperative allied health personnel.

To assist in making medical errors data useful or meaningful to medical staff, medical error events should be as well defined as possible. This will also allow for aggregation of data in order to set priorities or goals for error reduction. To encourage participation in medical error reporting systems, data collection activities should perhaps start by identifying a subset of types of medical errors or certain types of high risk or frequently performed surgeries or treatment procedures. For example, AAOS closed-claim studies targeted knee arthroscopy surgery as one area to study because, while it is a relatively low risk endeavor, it is the most frequently performed orthopaedic procedure, and, compared with other orthopaedic operations, has a relatively high incidence of wrong site surgery.

Medical error reporting systems should involve a continuous loop of communication and feedback among the medical professionals involved in the reporting process. To encourage participation in a medical error reporting system, in addition to providing assurances that the system is nonpunitive, a process whereby data providers can get immediate feedback on incidences similar to their report should be considered. This approach offers an additional incentive to the medical professional, perceived as getting something of value for reporting, while providing immediate constructive feedback to assist in ensuring safer practices in the future. The feedback could be in the form of similar events and include the findings of root causes and recommend actions to reduce future risks. At the very least, perhaps quantitative data on the number of same or similar incidences could offer the medical staff some perspective on where to focus their priorities for monitoring and modifying their procedures.

The AAOS believes that the success of a nationwide effort to reduce the number of medical errors can be achieved through a nonpunitive, cooperative environment. Patient confidentiality rights should be protected and appropriate legal protections of all information involved in all aspects of patient safety reporting systems should be carefully studied and established before such systems, including demonstration projects, are put into place.

To encourage comprehensive reporting, all information in connection with reporting systems, at all phases of the reporting process, should be privileged for purposes of federal and state judicial proceedings, both in civil matters and in administrative proceedings, including discovery, subpoenas, testimony, and other forms of disclosure. The submission of information to reporting systems, or the sharing of information with third parties for the purpose of improving patient safety, should not be construed as waiving any privilege of confidentiality recognized under state or federal law or established as part of a reporting system. All such information should be exempt from the Freedom of Information Act.

Part of the process of implementing a medical error reporting system and encouraging patient and provider cooperation should involve careful delineation, through appropriate education, of the legal rights and responsibilities of all participants.

One area, perhaps beyond the scope of the topic for this Summit, but worth mentioning, is that of informed consent. AAOS closed-claim studies continue to find a high number of malpractice claims based on lack of informed consent. Establishment of comprehensive, standardized documentation requirements and protocols for obtaining the patient's informed consent is an important place to start in reducing the number of medical errors and ensuring patient safety.

All phases of treatment should be well planned and documented. Consent processes and medical records should clearly outline the reasons for various treatment and surgical interventions. Records should indicate the extent of discussion with patients on specific risks, potential complications including infection and all possible outcomes. The leading physician, consulting physicians, and any other staff involved in the consent process, should be clearly identified to the patient. The full scope of what is required as a standard part of the patient's complete medical record should be clarified. While standard procedures may exist for hospitals and other facilities, ongoing monitoring and review are necessary.

The AAOS looks forward to working in a constructive partnership with AHRQ and other public and private agencies, including hospitals, medical professionals, and others to ensure safe patient practices.

Current as of September 2000

Internet Citation:

American Academy of Orthopaedic Surgeons. Additional Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/aaaos.htm

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