On Friday, October 15, 2010, in San Diego, CA, the APSF convened a 25th anniversary Board of Directors Workshop focused on a 360° assessment of the APSF. The goal of the workshop was to help answer the question, “How do we continue to help reduce serious adverse events in the perioperative period?” The speakers were encouraged to provide a critical view of how APSF might better address patient safety issues in the future. The workshop opened with Robert K. Stoelting, MD, and Jeffrey B. Cooper, PhD, explaining the purpose and conduct of the workshop and providing introductory remarks. Each of 8 carefully selected expert speakers were given 15 minutes to provide their perspectives on the APSF and recommendations as to actions and strategies that the APSF might take to continue to reduce serious adverse events in the perioperative period.
The first speaker was Peter B. Angood, MD, surgeon and former chief patient safety officer for The Joint Commission, and National Quality Forum senior advisor for patient safety. Dr. Angood opened with a vignette of a trauma patient he had encountered as a medical student. The patient experienced anesthesia awareness during an emergency exploratory laparotomy. Dr. Angood related that no follow-up was provided by the anesthesia or surgery teams, or the hospital. The conclusion by the anesthesia team involved was that it was “just sad that sometimes these things happen.” He also noted that the last surgery he performed before he retired from clinical practice also had intraoperative awareness. “The anesthesiologist apologized and that was it,” he stated.
Dr. Angood discussed the NQF structure, foundation, and mission to improve the quality of American health care. He noted that the drivers of change in health care include performance measurement, public reporting, payment, infrastructure (information technology and workforce), applied research, accreditation, and certification. and certification. He observed that the APSF is not well known outside of anesthesia and is therefore not involved in pending healthcare legislation and healthcare reform. Dr. Angood also questioned if the APSF structure has a process for measuring outcomes related to its efforts and mission.
Linda K. Kenney, the second speaker is president and executive director of MITSS (Medically Induced Trauma Support Service). She raised the question, “What can the APSF do for patients?” Ms. Kenney was a patient who underwent a popliteal fossa block complicated by a catastrophic intravascular injection and complicated difficult resuscitation. She presented her story in the APSF Newsletter approximately 5 years ago. She wanted to know what has happened since 1999 to address the emotional impact on families and caregivers after anesthetic complications, and what has APSF done to include patients in its initiatives and processes. She asked if the APSF had written to patients about anesthesia and patient safety. Ms. Kenney also related her experience undergoing a hernia repair under spinal anesthesia when she told her anesthesiologist, “I can feel that.” He said, “No you can’t,” and gave more sedation. She did not feel that he had listened to her. She recommended that we build a network of anesthesia professionals to give support to both providers and patients. She also questioned the APSF efforts regarding perioperative awareness and noted that little is available on this topic on the APSF website from the patient perspective. Ms. Kenney also suggested that we include patients on the APSF Board of Directors and that we carefully listen to patient input.
The third speaker, Lawrence W. Way, MD, provided the perspective of the surgeon. Dr. Way has been on National Patient Safety Foundation, the American College of Surgeons Patient Safety Committee, and the Quality Care Committee at the University of California at San Francisco. His son is also married to an anesthesiologist. Dr. Way began his presentation with descriptions of accident models including linear cause and effect, human error, latent failures (the “swiss cheese” model), control theory (blunt end failure), and normal accident theory (NAT). In normal accident theory accidents are inevitable in highly complex, tightly coupled systems. Multiple contributing causes converge in an ad hoc pattern to produce failure, but not in a repeatable fashion. NAT is now getting a lot of attention. Dr. Way explained that we need to look behind human error to examine systemic factors that give rise to flawed behavior. He stated that accidents result from complexity, and that complex systems develop goal conflicts from pressures for throughput, efficiency, and cost control in the face of limited time and resources. Dr. Way quoted Marcus Aurelius (160 AD): “We are too much accustomed to attribute to a single cause that which is the product of several and the majority of our controversies come from that.” Dr. Way explained the importance and effectiveness of postoperative debriefing and reminded us that feedback data should be analyzed, not just tabulated. He gave an example of a study including 4800 patients from the San Francisco Veteran Administration Medical Center, which utilized structured debriefings to search for delays, equipment problems, and unwanted events. Dr. Way also emphasized the importance of checklists and observed that surgeons need to become more involved in committees and process improvement.
Alexander A. Hannenberg, MD, current president of the American Society of Anesthesiologists (ASA) gave the perspective of the ASA. He complemented APSF as a jewel in the crown of anesthesiology and congratulated the APSF for not allowing itself to become complacent. Dr. Hannenberg discussed the PQRI, Medicare’s pay for performance program, and addressed payment incentives and the transition to payment penalties (carrot transitioning to the stick), as well as confidential reporting. He noted that public reporting is mandated in current health care legislation, and that www.hospitalcompare.gov is already in place. Dr. Hannenberg reviewed the issues of antibiotic administration, temperature maintenance, and the aseptic protocol for central line placement. He predicted that the antibiotic requirement would disappear because it had received enough attention, and that these initiatives do not really go to the heart of the specialty. Dr. Hannenberg reviewed prior and ongoing APSF initiatives including PCA safety, absorbent desiccation, audible alarms, medication administration, and infusion pump safety, but then asked, “ What is our strategy for getting the initiatives from the Newsletter to the bedside?” Dr. Hannenberg reviewed implementation timelines for other medical initiatives; for example, the beta-blocker use trial of 1982 did not reach the 90th percentile until 2004. It was adopted as a quality metric in 1996 by the JCAHO and it began to rise quickly. He noted that APSF needed the implementation piece to impact patient safety.
The fifth speaker was John J. McFadden, PhD, CRNA, associate dean and chair at Barry University in Miami and chair for the AANA Practice Committee. Lessons of honesty, courage, vanity, and service leadership were the initial focus points of his presentation. He found the APSF Newsletter to be an invaluable resource, but regrets the all-digital media. Appreciation was expressed for collaborative efforts and improving communication between providers, and between patients and providers. He noted that these important initiatives need to be continued. He reminded us to not forget the basics of preoperative machine check, hand washing, and preventing needle reuse. He also commented that the ongoing issues of provider wellness, fatigue, and production pressure continue to be important issues.
James C. Eisenach, MD, Editor-in-chief, Anesthesiology, was the sixth speaker and addressed the role of the APSF in consensus conferences and recommendations. Dr. Eisenach began his presentation with a discussion of the interplay between APSF recommendations and ASA guidelines. He reviewed the publication of ASA guidelines in the journal Anesthesiology. Further, Dr. Eisenach noted that some of the recommendations put forth by the APSF are different than published guidelines and acknowledged that there is a subjective component to these recommendations and guidelines. He proposed that if an organization, such as the APSF, puts forth and/or publishes recommendations or consensus conclusions for which guidelines currently exist, several items should be addressed. These include considering overlap with other societies’ guidelines, defending why a different conclusion has been reached, avoiding confusion between visions, goals, and strategies, and recognizing that patients may be harmed by consensus recommendations put forth in the absence of evidence. Dr. Eisenach reminded the audience that science trumps the process of induction, and recommending action without evidence may not always be the best idea.
The seventh speaker, Paul A. Baumgart, general manager of the Asia-pacific region for Tomo Therapy, Inc., shared the perspective of industries that support perioperative patient safety. He conversed with over a dozen industry partners prior to preparing this talk to give a more global industry perspective. When Mr. Baumgart was a surgical patient, he noted that the anesthesia machine to which he entrusted his life and safety was that of a competitor, but knew the machine that was putting him asleep was every bit as safe as the one he was marketing. Mr. Baumgart provided a historical perspective of the role industry played in the founding days of the APSF, including a $300,000 corporate contribution from Burt Dole and a $300,000 corporate contribution from W. D. Rountree. Mr. Baumgart admonished industry representatives present in the room that they have to put patient safety ahead of their corporate and financial interests, stating, “You must have a passion for patient safety.” In the 1980s companies were expending 20% of their corporate revenue for corporate liability costs. Industry must look at the APSF as an investment that can have a long-term return and be a long-term successful relationship. Corporate contributions are generally considered marketing expenses, not research and development (R&D) expense, and therefore run the risk of being cut. He also reviewed technology marketing curves and by example noted that the first commercial pulse oximeter was developed in 1964, cost $15,000, and weighed 36 lbs. Industry wants APSF to be a beacon and a bridge to help take technology from the Newsletter to the bedside. The APSF should make itself more accessible to industry to help review R&D roadmaps or specific development efforts and provide guidance and expertise for corporate partners in patient safety. This recommendation is consistent with the APSF Statement on Industry Relations.
The eighth and final speaker was Dr. Steven L. Shafer, MD, editor-in-chief of Anesthesia and Analgesia, addressing contributions that the APSF has made via research support and grants, and how the APSF should proceed in the future. Beginning with Dr. David Gaba’s 1987 APSF supported evaluation of anesthesiologist problem solving using realistic simulations, Dr. Shafer reviewed a detailed and extensive list of important research that was funded by the APSF. He also noted that anesthesia remains recognized as the leader of the patient safety movement and that the APSF has been acknowledged in the Institute of Medicine reports and by public media. Dr. Shafer’s recommendations for the future include continuing to use the APSF grant funding processes to fund research and to remain apolitical and inclusive.
Following these 8 presentations and a short break, a panel discussion was held which began with an observation by Dr. Stoelting that it is not generally possible to do randomized controlled trials (RCTs) for certain safety practices. The point was raised that if data are not available via evidence-based medicine, efforts should include expert opinions, with a vetting process so that recommendations and/or regulations such as the “locked-cart” issue do not arise. Dr. Hannenberg proffered that the APSF should not be hindered from making recommendations. Dr. Eisenach discussed the processes of drug approval by the FDA and the role of post-marketing surveillance, which can detect unanticipated problems and make appropriate modifications. Dr. Weinger asked what the evidence should be and reiterated that one cannot always do RCTs. Dr. Gaba similarly reminded the audience of evidence on fatigue and work hours for surgeons, housestaff, and anesthesia professionals. Dr. Angood recognized that rapid changes are afoot, and in light of the inability to do certain RCTs, there should be scoring and grading of evidence and updating of recommendations and guidelines. Dr. Morell stated that the APSF does not set standards, formal guidelines, or determine standards of care, but rather has issued recommendations and communicated consensus statements. Mr. Baumgart recommended that the APSF have an increased role with the [ASA] standards committee and should serve as a bridge. Dr. Hannenberg commended the APSF for bringing forth patient safety issues. Dr. Stoelting raised the issue of fire safety and asked if it is a problem to minimize open delivery of supplemental oxygen, as there is no hard evidence. Dr. Shafer recommended that the APSF be more transparent where these items arise and indicate what is expert opinion, what is evidenced-based medicine, and so forth.. He further reminded the group of the great job done by the American Heart Association in updating ACLS guidelines. Dr. Weinger asked how we engage other specialties in promoting perioperative patient safety. Dr. Angood noted that there is an existing perioperative council that is trying to gain traction, but it has been politically difficult. Dr. Warner proposed that the APSF name be changed to the Anesthesia and Perioperative Safety Foundation. He asked Dr. Hannenberg, who sits on the perioperative council, how APSF should go about gaining recognition from this group. Dr. Shafer noted that anesthesia issues may not reflect surgeons’ issues, and there are too many surgical subspecialty issues. He recommended that perhaps we should use the APSF model for these groups to come together. Dr. Hannenberg raised the interesting concept of the “medical and surgical home.” He noted that we live in the OR and could provide a common pathway for all of the surgical subspecialties, and manage the “surgical home.” The final component of the workshop was a set of small group breakout sessions. Each group was tasked with considering a specific question regarding what the APSF has done well and what the APSF could do better, and reporting to the entire group with recommendations. The following represents a synopsis of each group’s question and recommendations.
Group 1 was led by Dr. Mark Warner and considered the issue of communication with anesthesia professionals. This group recommended that the APSF reconsider the elimination of the APSF Newsletter hard copy. They also recommended that the APSF consider editorials on certain patient safety issues such as locked carts. A recommendation was made for a specific Newsletter column entitled “I’ll never do that again.” It was also proposed that synopses of important articles be submitted to Anesthesiology News and the AANA NewsBulletin. Finally, they recommended the development of a public advisory board to provide input on patient safety issues.
Group 2, was led by Maria Magro, CRNA, and considered the development of recommendations to facilitate positive change. This group commended the APSF on taking action when the evidence did not support recommendations (such as with pulse oximetry); demonstrating courage by addressing risk head on and effecting positive change; creating a safe environment for members to provide open input including anesthesiologists, CRNAs, anesthesiologist assistants, corporate partners, and the public; and demonstrating a commitment to valuing partnerships and collegial relationships among stakeholders. They noted the APSF accomplished these things by remaining apolitical, supporting the development of best practices in safe anesthesia care, using multimodal efforts to disseminate information, and funding research grants and projects. The group recommended that the APSF needs to do better in enhancing communication with stakeholders and increasing transparency of why certain recommendations are made. Further, mechanisms should be developed for feedback from the community at large with continuous closing of the loop, such as the use of a database to track the outcomes of patient safety initiatives. The group also recommended funding for long-term outcome projects and the development of registry type databases. Consideration should also be given to include a perioperative focus. Self-reflection and self-awareness strategies should be used for quality improvement within the organization. Better collaboration was called for with those who set the safety standards, such as the National Quality Forum. The group also recommended having a more receptive ear toward recommendations that can lead to collaborative efforts among other safety organizations.
Group 3, led by Dr. Robert Caplan, considered how to keep evolving the APSF agenda and identify and pursue future initiatives. Group 3 recommended that the APSF expand its scope of engagement to include providers in perioperative medicine, our consumer community, and the younger health care professionals who will next lead our specialty and organizations. Further the APSF should expand its focus to recognize the perioperative breadth of safety, the importance of short as well as long-term outcomes, the importance of major as well as minor injuries, and the reach of perioperative safety issues throughout the health care organization (not just inside the OR). Finally, the group recommended that APSF should expand research-funding strategies to continue its success in stimulating patient safety research.
Group 4, led by Dr. David Gaba, was tasked with considering how to create a true safety culture. This breakout group felt that they had a very difficult assignment in that safety culture is a very broad topic, and does not have a single agreed upon definition (although APSF has published a variety of articles in the Newsletter that have advanced the definition and conceptual basis for a safety culture in health care). Despite these challenges the group came up with several recommendations for possible activities of APSF to move the ball forward. In no particular order of priority, group 4 recommended that APSF:
- Should prepare a toolkit of materials to assist individuals, work units, and institutions to measure or intervene in the local safety culture. It was noted that APSF personnel have participated in projects that promulgate such measures and interventions.
- Broaden the concept of safety culture to include practitioner safety and also to consider the impact of safety culture on less than catastrophic negative outcomes. APSF should encourage the analysis of safety culture at higher levels of the health care endeavor, including the safety implications of the interaction between regulations of accreditors and regulators, on the one hand, and realities of clinical practice, on the other.
- Should encourage clinicians to be involved in and improve mechanisms of organizational learning that are important components of a safety culture including reporting and analysis systems and prospective analysis of risk of proposed changes in practice.
- Should prepare an educational video that explains safety culture and shows vignettes demonstrating both good and poor examples of safety culture.
With all speakers and groups providing their assessments and recommendations, and with a renewed sense of purpose and direction, the 2010 APSF Board of Directors workshop concluded. The APSF Executive Committee will review and take these recommendations under consideration focusing on those deemed to be most critical and practical. Great appreciation is extended to all speakers, moderators, organizers, and participants for enthusiastically helping the APSF strategize for the next 25 years to reduce serious adverse events in the perioperative period.