NEWSLETTER The Official Journal of the Patient Safety Foundation www.apsf.org

Volume 31, No. 3, 49–76 Circulation 122,210 February 2017

APSF President Robert K. Stoelting, MD A Tribute to 19 Years of Steadfast Leadership by Jeffrey B. Cooper, PhD

Any startup organization has a critical test of University before residency at the sustainability when it makes its first leadership University of California, San Francisco. After two transition. The APSF had the experience in 1997 years at the NIH, Dr. Stoelting joined the faculty when our beloved founder and leader, Dr. Jeep (Anesthesia and Pharmacology) at Indiana Univer- Pierce, passed on the reins of his Presidency to the sity in 1970, rising rapidly to become Professor and first successor. Jeep had the proverbial big shoes to Chairman of Anesthesia in 1977. Also extensively fill. Who could take on that role and not only involved in ASA committees and administration for sustain, but grow our vital yet still adolescent band many years, Dr. Stoelting was a District Director of anesthesia patient safety advocates? It was our before becoming Vice-President for Scientific exceptional good fortune that Dr. Bob Stoelting was Affairs. Possibly best known as an educator for his willing to take the challenge. Nineteen years later, prodigious and prestigious authorship of important Dr. Stoelting, too, has passed on the reins to a and very widely used textbooks (Basics of Anes- successor. We all owe so much to Bob for the thesia, Pharmacology and Physiology in Anes- continued, steady effort to not just keep anesthesia thetic Practice, and Anesthesia and Co-Existing relatively safe, but to also make it even safer. He has Disease as well as co-editing Clinical Anesthesia been a remarkable leader, colleague, and passionate with Drs. Barash and Cullen and editing periodicals crusader for our common goal: that no patient shall such as the Yearbook of Anesthesiology and be harmed by anesthesia. Advances in Anesthesia), Dr. Stoelting has been a Director and the President of the American Board of Dr. Stoelting came to the position of President of Anesthesiology. He has been Chairman of the Robert K. Stoelting, MD the APSF (POTAPSF) as one of anesthesiology’s ACGME Anesthesiology Residency Review Com- most esteemed academic leaders. This is what was Board of Trustees). Dr. Stoelting brings this truly mittee, and is a Director of the Foundation for Anes- written about him when he assumed the APSF Pres- thesia Education and Research. This Spring, he will remarkable background to his new role as the leader idency in 1997: deliver the T.H. Seldon Memorial Lecture to be of the APSF, which will benefit greatly as it moves Dr. Stoelting, most recently ASA Vice- entitled “Anesthesiology—a medical specialty with forward into the next century from the vision and President for Scientific Affairs until this year, is a unique challenges and opportunities” at the Annual wisdom. Dr. Stoelting has gained from the extraor- 1 native of Indianapolis, Indiana, who received his Meeting of the International Anesthesia Research dinary breadth and depth of his career. undergraduate and medical educations at Indiana Society (for which he has also served as Chair of the See “Tribute,” Page 51

Conflict in the Operating Room: Impact on Patient Safety Report from the ASA 2016 Annual Meeting’s APSF Workshop by Mark A. Warner, MD, and David J. Birnbach, MD, MPH The APSF Board of Directors Workshop entitled patient safety. If you are like many of us and enjoy stage play. The outcomes for each scenario are pro- “Conflict in the Operating Room: Impact on Patient learning from actual cases that have teachable vided and include both patient outcomes and medi- Safety” was held on Saturday, October 22, 2016, at moments, you can find the scripts for these scenarios colegal, institutional (e.g., loss of privileges), and the McCormick Place Convention Center in Chicago, on the APSF website (www.apsf.org). It takes only a licensure results associated with the conflicts. IL. This workshop used six actual case scenarios simple mouse click to access them from the website The names and locations used in the scenarios (Table 1) to trigger discussions and reflections on the (top buttons, far right, “ASA 2016”). We encourage are modified for privacy reasons but the stories are very real, negative impact that conflicts between per- you to read them; each takes only a single minute to real. We served as moderators for the workshop; sonnel in the perioperative period can have on read and the script is written in the style of a short See “Conflict,” Page 54 TABLE OF CONTENTS, NEXT PAGE APSF NEWSLETTER February 2017 PAGE 50

Table of Contents Articles: APSF President Robert K. Stoelting, MD: A Tribute to 19 Years of Steadfast Leadership...... Cover Conflict in the Operating Room: Impact on Patient Safety Report from the ASA 2016 Annual Meeting’s APSF Workshop...... Cover NEWSLETTER Large Anesthesia Groups/Practice Management Companies Discuss the Impact of The Official Journal of the Anesthesia Patient Safety Foundation Production Pressures on Patient Safety with APSF Leaders...... Page 55 The Anesthesia Patient Safety Foundation Newsletter Immediate Past-President’s Report Highlights Accomplishments of 2016...... Page 57 is the official publication of the nonprofit Anesthesia Distractions in the Anesthesia Work Environment: Impact on Patient Safety...... Page 59 Patient Safety Foundation and is published three times per year in Wilmington, Delaware. Individual Distractions in the Operating Room: An Anesthesia Professional’s Liability?...... Page 59 subscription–$100, Cor­por­ate–$500. Contri­butions to 2016 National Geriatric Surgical Initiatives...... Page 62 the Foundation are tax deduct­ible. ©Copy­right, TAKE THE SURVEY! Hospital Power Failure: A Safety Hazard...... Page 63 Anesthesia Patient Safety Foundation, 2017. The opinions expressed in this Newsletter are not Start with the 2017 EC Pierce Lecture: Safety Beyond Our Borders...... Page 68 necessarily those of the Anesthesia Patient Safety The Anesthesia Professional’s Role in Patient Safety During Transcatheter Aortic Valve Replacement.....Page 73 Foundation. The APSF neither writes nor promulgates standards, and the opinions expressed herein should Letters to the Editor: not be construed to constitute practice standards or Letter to the Editor: Don’t Forget the Routine Endotracheal Tube Cuff Check! ...... Page 69 practice parameters. Validity of opinions presented, Letter to the Editor: Error in Inhaled Nitric Oxide Setup Results in “No Delivery of iNO”...... Page 71 drug dosages, accuracy, and completeness of content are not guaranteed by the APSF. Letter to the Editor: Air Leak in a Pediatric Case—Don’t Forget to Check the Mask!...... Page 72 APSF Executive Committee: APSF Announcements: Mark A. Warner, President; Jeffrey B. Cooper, PhD, Introduction to New APSF President, Mark A Warner...... Page 53 Executive Vice President; George A. Schapiro, Executive Vice President; Steven R. Sanford, JD, Vice Corporate and Anesthesia Practice Management Companies Advisory Council...... Page 54 President; Matthew B. Weinger, Secretary; Casey D. SAVE THE DATE: APSF Sponsored Conference: Perioperative Handoffs...... Page 55 Blitt, MD, Treasurer; Douglas A. Bartlett; David J. Medtronic Grant Acknowledgement...... Page 58 Birnbach, MD; Robert A. Caplan, MD; Daniel J. Cole, MD; David M. Gaba, MD; Steven B. Greenberg, MD; 2017 APSF Grant Recipients...... Page 64 Steven K. Howard, MD; Lorri A. Lee, MD; A. William APSF Corporate Supporter Page...... Page 66 Paulsen, PhD, AA-C, Richard C. Prielipp, MD; Maria van Pelt, CRNA, PhD. Consultants to the Executive APSF Donor Page...... Page 67 Committee: John H. Eichhorn, MD; Bruce P. Hallbert, APSF Website Offers Online Educational DVDs...... Page 68 PhD; Marjorie P. Stiegler, MD. Anesthesia Patient Safety Foundation Officers, Directors, and Committees, 2017...... Page 70 Newsletter Editorial Board: Invitation to Submit and Deadline for January 1, 2018, APSF Grant...... Page 72 Lorri A. Lee, MD, Co-Editor; Steven B. Greenberg, MD, Co-Editor; Sorin J. Brull, MD; Joan M. Christie, Deadline for Safety Scientist Career Development Award (SSCDA)...... Page 75 MD; Jan Ehrenwerth, MD; John H. Eichhorn, MD; Glenn S. Murphy, MD; Wilson Somerville, PhD; Jeffrey Vender, MD. APSF Newsletter Address all general, contributor, and sub­scription correspondence to: Address all general, contributor, and guide for authors subscription correspondence to: Administrator, Julie M. Tuohy The APSF Newsletter is the official journal of the to the editors. Commercial products are not advertised Anesthesia Patient Safety Foundation Charlton 1-145 Anesthesia Patient Safety Foundation. It is published or endorsed by the APSF Newsletter; however, upon Mayo Clinic three times per year, in June, October, and February. The occasion, articles about certain novel and important 200 1st Street SW APSF Newsletter is not a peer-reviewed publication, and technological advances may be submitted. In such Rochester, MN 55905 decisions regarding content and acceptance of instances, the authors should have no commercial ties E-mail: [email protected] submissions for publication are the responsibility of the to, or financial interest in, the technology or commercial Address Newsletter editorial comments, questions, letters, editors. Individuals and/or entities interested in product. The editors will make decisions regarding and suggestions to: submitting material for publication should contact the publication on a case-by-case basis. Lorri A. Lee, MD editors directly at [email protected] and/or greenberg@ If accepted for publication, copyright for the Co-Editor, APSF Newsletter apsf.org. Full-length original manuscripts such as those accepted article is transferred to the Anesthesia Patient [email protected] that would normally be submitted to peer review Safety Foundation. Except for copyright, all other rights Steven B. Greenberg, MD journals such as Anesthesiology or Anesthesia & Analgesia such as for patents, procedures, or processes are retained Co-Editor, APSF Newsletter are generally not appropriate for publication in the by the author. Permission to reproduce articles, figures, [email protected] Newsletter due to space limitations and the need for a tables, or content from the APSF Newsletter must be Send contributions to: peer-review process. Letters to the editor and occasional obtained from the APSF. brief case reports are welcome and should be limited to Anesthesia Patient Safety Foundation 1,500 words. Special invited articles, regarding patient All submissions should include author affiliations 1061 American Lane Schaumburg, IL 60167-4973 safety issues and newsworthy articles, are often solicited including institution, city, and state, and a statement by the editors. These articles should be limited to 2,000 regarding disclosure of financial interests, particularly in Or please donate online at www.apsf.org. words. Ideas for such contributions may also be directed relation to the content of the article. APSF NEWSLETTER February 2017 PAGE 51

Tribute to Dr. Robert K. Stoelting, APSF President 1997-2016

“Tribute,” From Cover Page APSF was incredibly fortunate that Bob Stoelt- ing was ready and eager for even more national service, leadership, challenge, and impact. While that might have been via the ASA, he chose to dedicate the next phase of his career to patient safety via APSF. Despite his vast knowledge and experience in anesthesiology, Bob hadn’t yet focused on patient safety alone. However, through his participation and leadership in APSF, he adroitly directed his energies forward. Like everything he has done in his life, he undertook this responsibility with total dedication, passion Dr. Stoelting led the development of the widely down- Dr. Stoelting provided decisive leadership for developing for learning, wisdom, and effective leadership. His loaded “Fire Safety Video” for prevention of on-patient numerous patient safety initiatives by convening rele- prior experience in clinical anesthesia, research, fires in the operating room. vant stakeholders at targeted conferences and workshops. and academic and organizational leadership in the field prepared him better than anyone to take on this prestigious role. There are so many wonderful, effective qualities about Bob Stoelting that have enabled APSF’s contin- ued influence. Most important is his leadership style. The 19-member multidisciplinary Executive Committee is the main working instrument of APSF, and we are not a shy bunch. The discussions at meetings are always collegial and respectful, but sometimes intense. We have a lot of opinions and are not always good at self-policing. Bob was fantastic at keeping us on track, yet allowing creativity to emerge. He always guided the group to seek consensus, which we almost always could achieve. Yet, when consensus was not initially present, he diplomatically steered us to a place where we could agree on a direction or decision that led to positive changes for patient safety. APSF was fortunate that this was one of many of Bob’s leadership attributes. For the 31 years since the founding of APSF, I’ve Left to right, Drs. Dorsch, Olympio, Kharasch, Woehlck, Stoelting,and Eger speak at the APSF Conference on Safety experienced a substantial turnover of the Executive Considerations of Carbon Dioxide Absorbents on July 27, 2005, in Chicago, IL. (APSF Newsletter. 2005;20:25.) Committee membership as members retired. What is so remarkable is how the original culture of beyond!), that he holds and lives with the highest by project. He understands that culture change is dedication, trust, and mutual respect has endured. ethical standards, that he listens and is entirely the sum total of what we do as individuals, not a That is in no small measure a result of how Bob open to dissent, and can change his mind based on magical force or prescribed, demanded actions. He Stoelting models and enables the behaviors that are what he learns from others. Most notable is that he has instantiated this philosophy through the steady essential to the continuity of that culture, which I does all of this with humility and grace. stream of projects and concepts that are the product believe have been essential to our ongoing of what APSF does. That product has been effectiveness. I have never experienced such an I haven’t heard Bob Stoelting espouse a specific disseminated primarily via the APSF Newsletter, extended level of collegiality and mutual respect in philosophy or strategy for how patient safety in any organization. It’s what has kept me going at the anesthesia should be maintained and continuously which is now distributed widely to about 122,000 same level of interest and commitment all these improved. Instead, it is my interpretation that he people around the world, and available free of years. Like Jeep before him, Bob has made that has guided APSF and its patient safety strategy charge to anyone on our website. The message of possible by how he helps shape the composition of through continuous, steady progress. Rather than APSF is further disseminated via the workshops the team and how he leads it, with a light, but big leaps forward or forced changes in behavior, and consensus conferences that Bob either has led highly leveraged touch. Bob (similar to his patient safety is a continual series of small steps that himself or guided us on the Executive Committee predecessor) perpetuated the axiom that anesthesia make everyday work and processes safe. It’s not a to develop and lead every year. patient safety is a multidisciplinary, collaborative big bang or a revolution, but rather a continuous The following observations don’t provide a process. He has always embraced ideas from a evolution. As individual providers and their orga- complete history of the 19 years that Bob has been variety of providers, business leaders, and national nizations change their practices to be safer, the cul- at the helm of APSF. However, they are examples of organizations to further the quest to improve ture changes. It’s not just the changing of practices; patient safety. In all that he does, he conveys his it’s the growing commitment and enlightened atti- specific projects and programs he has championed respect for all of us (on the executive committee and tudes to continuously make anesthesia safer, project See “Tribute,” Next Page APSF NEWSLETTER February 2017 PAGE 52

Stoelting: A True Icon in Anesthesia and Patient Safety “Tribute,” From Preceding Page to Prevent to illustrate how this philosophy of issue-by-issue Postoperative Respiratory safety improvements has affected change: Depression or -Induced APSF Consensus Conferences Ventilatory Impairment (OIVI) (now known as the annual Through Bob’s leadership and advocacy, APSF Stoelting Conference) has taken a strong stand to promote postoperative Bob promoted these events, which have become monitoring for early detection of respiratory one of the important mechanisms by which we depression related to residual . APSF has identify solutions to current patient safety issues hosted multiple consensus conferences and work- and, from those, choose which initiatives to pro- shops on this topic as well as produced an educa- mote vigorously. Each year, the Executive Commit- tional video for prevention of this high acuity Dr. Stoelting initiated the annual APSF conference in tee, under Bob’s guidance, chose a topic and leader patient safety issue (http://www.apsf.org/news- Phoenix, AZ, where relevant stakeholders are invited to to run the conference. Through his skillful manage- letters/html/2007/winter/01_opioids.htm; participate in the development of consensus statements for ment of APSF talent and creativity, almost entirely http://www.apsf.org/resources/oivi/). specific patient safety issues. The APSF has recently from volunteers, we’ve shared the workload and named this annual meeting the “Stoelting Conference” in had a diversity of topics and speakers. Beach Chair Position honor of Dr. Stoelting’s tireless dedication to patient safety. The hazards of positioning with inadequate Setting Audible Critical Alarms cerebral perfusion were identified, and research tions that stick are still elusive. The APSF has Bob overcame controversy to steer APSF to into this important issue was funded. Potential make a strong statement about the need to set preventive measures, such as maintenance of ade- advocated for the “Standardization, Technology, critical audible alarms, rather than disabling them quate cerebral perfusion using correction for Pharmacy/Pre-filled/Pre-Mixed, Culture (STPC)” to avoid possible false positive signals that height differences between the brain and the site paradigm for optimal management of subsequently could lead to unsafe situations or of blood pressure measurement, were recom- (http://www.apsf.org/newsletters/html/2010/ adverse events (http://www.apsf.org/newslet- mended. As a result, awareness of this patient spring/01_conference.htm; http://www.apsf. ters/html/2004/winter/01workshop.htm). safety issue has been heightened among anesthe- org/resources/med-safety/). sia professionals today (http://www.apsf.org/ CO2 Absorbent Interactions newsletters/html/2009/spring/01_cerebral.htm; Postoperative Visual Loss with Volatile Anesthetics http://www.apsf.org/newsletters/html/2010/ Bob worked alongside multiple organizations winter/01_workshop.htm). This was the topic of the first APSF consensus and stakeholder groups to educate providers about conference (2005), which was convened because of Safety this topic and promoted research and preventive the concern for the potentially dangerous efforts. The APSF convened a consensus conference by-products and flammable reactions that could This has been one of Bob’s great interests. The and produced an educational video on this debili- APSF has convened several workshops and con- occur with exposure of volatile anesthetics to CO2 tating patient safety issue (http://www.apsf.org/ absorbent. This meeting led to solid recommenda- sensus conferences on this topic, produced an edu- newsletters/html/2013/winter/06_conference. cational video, and published numerous reports tions promulgated through the APSF Newsletter htm; http://www.apsf.org/resources/povl/). (http://apsf.org/newsletters/html/2005/summer/ and articles on it in the APSF Newsletter. While 01co2.htm). awareness of this issue surely is higher, deep solu- See “Tribute,” Next Page

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Drs. Stoelting and Pierce pose at the APSF ASA booth. APSF NEWSLETTER February 2017 PAGE 53

Nineteen Years of Leading APSF Patient Safety Initiatives “Tribute,” From Preceding Page Emergency Manuals/Checklists Bob spearheaded and co-chaired the 2015 Annual APSF Consensus Conference on Imple- menting Emergency Manuals/Checklists. The con- ference attendees and faculty concluded that the APSF could play a lead role in advocating, educating, and researching the implementation of the highest quality manuals/checklists in the operating room to make patients safer (http:// www.apsf.org/newsletters/html/2016/ February/08_EmerManuals.htm). Videos Dissemination of APSF Initiatives Approximately 10,000 copies of videos related to Dr. Stoelting presents the Ellison C. “Jeep” Pierce, Jr., MD, Best Scientific Exhibit in Patient Safety Award at the 2005 specific patient safety problems such as on-patient ASA meeting. This annual award encourages development of patient safety projects from all anesthesia professionals. The award in 2005 was for the project “Macintosh- and IBM-compatible Laptop-based Videography of Airway Manage- fires in the operating room, medication safety, opi- ment for Teaching Airway Management and Record Keeping” from Brett L. Arron, MD, Richard Gillerman, MD, and oid-induced ventilatory impairment, and postopera- James E. Peacock, RN, of Rhode Island Hospital, Providence, RI. Dr. Stoelting (left) presents the award while Committee tive visual loss have been distributed from APSF Members Richard Prielipp and Tricia Meyer look on. (APSF Newsletter 2005-2006;20:82.) either via download or DVDs from the apsf.org web- site. The fire safety video alone has been distributed or accessed 8,000 times and is used to raise aware- prodigious worker. Most importantly, his love of his anesthesia patient safety. All patients having the ness and teach health care professionals how to pre- wife, Natalie, and family is inspiring. He genuinely experience of anesthesia are better off for his having vent and respond to operating room fires (http:// cares for people and has a warmth and charm that been our selfless, dedicated, and effective leader. www.apsf.org/resources/fire-safety/). shine when he sees mentees succeed. Jeffrey Cooper currently serves as Executive Vice Given Bob’s larger-than-life, well-deserved All of us on the Executive Committee are happy President of the APSF and he has been an active reputation in our specialty, those who don’t know him for Bob that he has chosen to move on to the next member of the APSF Executive Committee from 1985 may think he’s very serious and formal. They would phase of his life. He’s still full of vigor and will to the present. He is also Professor of Anaesthesia at surely explore new and stimulating things. He also be mistaken. He has a remarkable sense of humor. It Harvard Medical School in the Department of Anesthe- may not be immediately evident to those who don’t successfully steered us through the process of sia, Critical Care & Pain , Massachusetts know him well and who respect him so much as a selecting his successor, Mark A. Warner, MD, fulfill- General Hospital, Boston, MA. senior statesman for our specialty, but he’s a master of ing his responsibilities, as always, to APSF and the one-liners and self-deprecating stories. It’s these anesthesia community. He will be missed at the Reference attributes that make him so good at leading meetings; head of our EC table for all that he has brought 1. APSF Newsletter. Winter 1997. http://www.apsf.org/ they enable his team to discuss intense issues in a these many years. We wish him the best and thank newsletters/html/1997/winter/leadership.html. productive and even enjoyable environment. He is a him for all that he has given to the APSF and to Last accessed 1/2/2017.

Introducing the New President of APSF

Dr. Mark Warner received his undergraduate degree Academy of Anesthesiology. He also has been an editor from Miami (Ohio) University in 1976, his MD degree for Anesthesiology, the journal of the American Society of from the Medical College of Ohio in 1979, and his Anesthesiologists. subsequent training in anesthesiology at Mayo Clinic. He and his wife, Mary Ellen, also an anesthesiologist at He is currently the Annenberg Professor in Mayo Clinic, have four grown sons. Two of them are Anesthesiology at the Mayo Clinic and emeritus anesthesiologists at Mayo Clinic. Mark is an experienced Executive Dean of the Mayo Clinic College of Medicine. pilot and sky-diver. Mary Ellen and Mark spend much of Mark has served as Chair of the Department of their spare time traveling to see their grandchildren and Anesthesiology, the physician leader of Mayo’s working on their farm. hospitals, and a member of Mayo’s Board of Governors. Dr. Warner brings his years of experience, Mark has been in the leadership of a number of incomparable leadership skills, and incredible breadth of national anesthesiology organizations. He served as knowledge to the APSF as current President. Mark A. Warner, MD President of the American Society of Anesthesiologists, He can be contacted at his email address, warner@ New APSF President the American Board of Anesthesiology, and the apsf.org. APSF NEWSLETTER February 2017 PAGE 54

Conflict Scenarios at the APSF Workshop ANESTHESIA PATIENT “Conflict,” From Cover Page Anesthesia Professionals Matter SAFETY FOUNDATION anesthesiologists Emily E. Sharpe, MD, Bridget P. In several of the scenarios, anesthesia providers Corporate and Anesthesia Pulos, MD, and Amy C. Pearson, MD (each from likely had the ability to add positive influences into Practice Management Mayo Clinic, Rochester, MN), joined us in acting perioperative conflicts—and failed to provide the as the characters in the scenarios. As you might reasonable, knowledgeable, and calming influences Companies Advisory Council expect, surgeons, nurses, and anesthesiologists that they could have. Everyone in the workshop’s were key players in the actual scenarios. audience agreed that proactive avoidance of poten- There is remarkable educational value in reading tial conflicts by pre-event collaborations and discus- George A. Schapiro, Chair the scenarios and reflecting on them and the impact sions was the best approach to preventing APSF Executive Vice President that the conflicts in each had on the patients’ out- perioperative conflicts. However, when they have Jimena Garcia...... Baxter Healthcare comes. Here are our observations based on reflections already occurred and are ongoing, failure to engage and comments from the 167 workshop participants, and de-escalate building conflicts (e.g., avoidance) Timothy Vanderveen, each of whom joined discussions with colleagues after and succumbing to biases (e.g., choosing sides and PharmD...... Becton-Dickinson the cases were individually introduced: hierarchical influences) result in lost opportunities to Ann M. Bilyew...... ClearLine MD resolve or positively impact them. Anesthesia pro- Dan J. Sirota...... Cook Medical Outcomes Matter viders have the professional status to promote reso- The first three scenarios, including their out- lution of perioperative conflicts if they are willing to David Karchner...... Dräger Medical comes, were presented and discussed in small engage and if they use their interpersonal skills to Leslie C. North, RN...... Eagle Pharmaceuticals groups. Participants subsequently asked that the influence those involved in the conflicts. Societal last three of the six scenarios be presented without expectations are that anesthesia professionals should Angie Lindsey...... Fresenius Kabi, USA sharing their outcomes until the small group dis- and must protect their patients. This includes pro- Matti E. Lehtonen...... GE Healthcare cussions had occurred. The participants found that tecting them from the potential harm that may result Steven J. Barker, knowing the outcomes swayed their opinions and from perioperative interpersonnel conflicts. introduced biases into their perspectives on each of MD, PhD...... Masimo Dr. Warner is currently President of the APSF and the characters. This “hindsight bias” phenomenon Richard L. Gilbert, the Annenberg Professor in Anesthesiology at the Mayo has been well known (Psych Bull 1990;107:311-27). It MD, MBA...... MEDNAX influences many medicolegal and regulatory Clinic. He is emeritus Executive Dean of the Mayo actions taken against providers. Examples include Clinic College of Medicine and former Chair of the Patricia Reilly, CRNA...... Medtronic larger jury awards when harmed patient plaintiffs Department of Anesthesiology at the Mayo Clinic. Rachel A. are present during trials and more significant nega- Dr. Birnbach is currently a member of the APSF Hollingshead, RN...... Merck tive actions by licensing boards when patient out- Executive Committee and APSF Board of Directors. He Jeffrey M. Corliss...... Mindray comes are known at the times of deliberation. Test is Vice Provost of the University of Miami and Profes- your own potential hindsight bias by reading sev- sor of Anesthesiology, Obstetrics and Gynecology, and Kathy Hart...... Nihon Kohden eral of the workshop’s six scenarios and their out- Public Health. He is Senior Associate Dean and and the America comes (“Hey, I knew that might happen.”), and Director of the University of Miami-Jackson Memorial then reading several of the scenarios without their John Di Capua, MD...... North American Hospital Center for Patient Safety. outcomes (“Wow! I wouldn’t have thought that Partners in Anesthesia would have happened.”). All of us can learn by Neither author has any financial conflicts to dis- (NAPA) understanding this phenomenon. close associated with this article. Joshua L. Lumbley, MD...... NorthStar Anesthesia Dustin R. Crumby, RN...... Pall Corporation Table 1: Conflict TBD...... PharMEDium Services Scenarios Used at the John C. Dalton, MD...... PhyMED Healthcare APSF Workshop Group Steven R. Sanford, JD ...... Preferred Physicians Medical Risk 1. Anesthesia professional refuses to follow institution’s sterile precautions policy during central venous Retention Group catheter placement; conflict between O.R. nurse and anesthesia professional Diana Gelston...... Respiratory Motion 2. Surgeon refuses to delay elective procedure of a patient who has multiple co-morbidities, hyperkalemia, Andrew Greenfield, MD....Sheridan Healthcorp and overdue dialysis; conflict between surgeon and anesthesia professional Tom Ulseth...... Smiths Medical 3. Orthopedist demands to use new bone cement that has not yet been introduced into the medical center; conflict between O.R. nurse and surgeon Andrew Levi...... Spacelabs Whitney Reynolds...... Teleflex 4. Surgeon refuses to allow transfusion of a patient who has lost 1 liter of blood; conflict between surgeon and anesthesia professional Leona England Rice...... The Doctors Company Foundation 5. Surgeon will not return to hospital to re-explore a patient whom the anesthesia professional believes is bleeding profusely into his abdomen; conflict between surgeon and anesthesia professional Kristin Bratberg...... US Anesthesia Partners 6. A high-volume obstetrician demands to perform a weekend elective cesarean section for placenta Casey D. Blitt, MD, APSF Treasurer accreta although it is against medical center policy; conflict between obstetrician, institutional medical Mark A. Warner, MD, APSF President director, and anesthesia professional APSF NEWSLETTER February 2017 PAGE 55

Large Anesthesia Groups/Practice Management Companies Discuss the Impact of Production Pressures on Patient Safety with APSF Leaders

by Robert K. Stoelting, MD On September 8, 2016, the Anesthesia Patient Safety Foundation (APSF) invited representatives Table 1: Large Anesthesia Groups and Practice Management Companies Represented of large anesthesia groups and practice manage- Anesthesia Associates of Ann Arbor NorthStar Anesthesia (Irving, TX) ment companies to meet with members of the APSF Executive Committee to discuss the patient Anesthesia Associates of Massachusetts (Boston, MA) Northwest Anesthesia Physicians, Springfield, OR safety implications of production pressures. Atlantic Anesthesia Old Pueblo Anesthesia (Tucson, AZ) Thirty-five attendees representing 24 large anes- Cleveland Clinic (Cleveland, OH) Physician Anesthesia Services thesia groups or practice management companies participated in the half-day session (Table 1). These 24 Community Health Systems (Franklin, TN) PhyMED Healthcare Group (Nashville, TN) entities represented a wide geographical cross-section Department of Veterans Affairs Sheridan Healthcorp of the United States and a variety of practice models that included all categories of anesthesia profession- Gulf Shores Anesthesia Associates Southern Arizona Anesthesia (Tucson, AZ) als. The American Society of Anesthesiologists (ASA), Integrated Anesthesia Associates (East Hartford, CT) Tejas Anesthesia (San Antonio, TX) American Association of Nurse Anesthetists (AANA), and American Academy of Anesthesiolo- Kaiser Permanente US Anesthesia Partners gist Assistants (AAAA) were also represented. Kaiser Permanente Nurse Anesthetists Association (KPNAA) Valley Anesthesiology and Pain Consultants (Phoenix, AZ) As an introduction to the conference, Robert K. Stoelting, MD, APSF president, described the three Mayo Clinic (Rochester, MN) Vanderbilt University School of Medicine (Nashville, TN) options that he believes are available for APSF North American Partners in Anesthesia (NAPA) West Central Anesthesiology Group safety recommendations to become “best prac- tices.” One option is for professional associations (ASA, AANA, AAAA) to adopt APSF safety rec- involve large anesthesia groups and practice companies to embrace relevant anesthesia patient ommendations in the form of policy statements management companies is APSF’s hope that these safety initiatives advocated by APSF. (Practice Advisories) that would be applicable to entities would individually endorse and adopt all association members. A second option is Following these introductory comments, the selected APSF safety recommendations that are “spreading the word” among individual anesthe- safety implications of production pressures were sia professionals via social media and educational relevant to their practices and resources. Dr. Stoelt- discussed with podium presentations by Drs. materials (conference reports in the APSF Newslet- ing proposed that “closing the loop” on APSF David M. Gaba, Samuel DeMaria, Mary Ann ter, APSF educational videos). A third option for safety practices” represents an opportunity for Vann, Myriam P. Garzon, and Brian J. Camma- effecting change and the principal reason to large anesthesia groups and practice management See “Comments,” Next Page

Save the Date Stoetin Confeene Roya Pas Resot and Sa, Phoeni, A Wednesday, September 6, 2017 Peioeatie Handoffs: Ahiein Consensus on Ho to Get it Riht

Handoffs in health care are potential patient safety risks, but are also opportunities to identify missed problems. Perioperative handoffs, including those occurring intraoperatively, from the OR to PACU or OR to ICU, have both common and unique issues. In this 1-day consensus-building workshop, APSF aims to identify critical elements of handoff processes, including how to conduct Jeffrey B. Cooper, PhD handoffs safely and how to implement new handoff processes that work locally. Jeffrey B. Cooper, PhD, and Meghan B. Lane-Fall, MD, MSHP, will be the co-moderators of this workshop, which will include expert presentations and panel discussions. The primary focus of this meeting will be achieving consensus about key issues through closely facilitated working groups. If you have expertise or an interest in helping to improve handoffs, consider participating.

If you ae inteested in attendin, ease ontat Juie Tuohy, APSF adinistato, at tuohyuieayoedu Sae is iited Meghan B. Lane-Fall, MD, MSHP APSF NEWSLETTER February 2017 PAGE 56

Large Anesthesia Groups/Practice Management Companies Tackle the Problem of Production Pressures

“Comments,” From Preceding Page Table 2: Observations Based on Podium Presentations rata. Common observations from their presenta- tions are summarized in Table 2. Production pressure is overt or covert pressure to place production, not safety, as a priority. During the final hour of the conference, attendees Anesthesia professionals must recognize that production pressures exist and continue to be pre-eminent patient advocates were divided into small groups to meet with mem- by supporting and practicing a culture of safety. bers of the APSF Executive Committee to discuss four When efficiency and quality become unbalanced, patient safety implications can ensue. questions relevant to patient safety and production pressures. The comments and recommendations Experience in nonmedical areas shows that incentives to put production ahead of safety may cause catastrophic accidents. from the small groups are summarized in Table 3. Ultimately, risk to the patient must be balanced by potential benefit to the patient, not to clinicians or the organization. As the moderator of the conference and author of this report, I am taking the liberty of expressing External pressures to work faster and more efficiently, and internal pressures to keep working despite fatigue or to get a personal editorial viewpoint based on the small along with colleagues, may have detrimental effects (stress, burnout) on the anesthesia professional’s health. group comments to Question 4 (Table 3): Are there “production pressures” that have a recog- nized or potential positive impact on patient safety? As background, a front page article in the Table 3: Comments and Recommendations Based on Small Group Discussions June 21, 2005, Wall Street Journal entitled, “Once Seen as Risky, One Group of Doctors Changes Question 1: Question 3: In your practice, what do you consider to be How can APSF best address patient safety Its Ways,” observed, “Rather than pushing for the most important “production pressure” issues presented by “production pressures?” laws that would protect them from patient law- patient safety issues in terms of potential harm suits, these anesthesiologists focused on improv- to patients? ing patient safety.” Perhaps, anesthesia professionals can turn the “negative knee jerk • Excessive focus on time and not safety • Highlight the evolving dangers of production pressures reaction to production pressures” into a patient • Limited staffing numbers (especially satellite in an APSF Newsletter article safety opportunity by endorsing and following locations), often driven by budget issues • Publish a report of this conference the small group responses to Question 4 (Table 3). • Push to go fast and limit use of resources • Publish vignettes or case reports of harm Large anesthesia groups and practice manage- • Multiple rooms as first start • Sponsor conferences to increase awareness of this ment companies in partnership with APSF have a • Emphasis on turnover times issue unique opportunity to pursue our common goal • Inappropriate patient selection • “Close the loop” with anesthesia professional that “no patient shall be harmed by anesthesia.” organizations to develop multimedia curricula on • Difficult elective cases during off-hours issues related to safety and production pressures Robert K. Stoelting, MD • “ All about the money” economic pressures with • Develop a “request for proposal” to study this topic Immediate Past President, APSF disregard for safety • Patient demand: “I want my NOW!” • Timely arrival of surgeon • Pressure to start prior to receiving lab or test results that are pending • Potential for missed information about patient

Question 2: Question 4: In your practice, how have you confronted and Are there “production pressures” that have a neutralized the patient safety issues created by recognized or potential positive impact on “production pressures?” patient safety? • Confront budget and administrative structure with • Can make the anesthesia professional more efficient safety concerns while still safe—a new norm • Create a culture of respect, cooperation, and • Promotes development of checklists, protocols and communication standardization • Create a preoperative anesthesia clinic • Encourages the anesthesia professional to function as • Preoperative anesthesia clinic a consultant • Staggered operating room starts • Facilitates increased communication and collaboration • Use a second anesthesiologist’s opinion/chief quality • Creates the potential to reduce waste and inefficiency officer to back up and review decisions • Multidisciplinary efforts to reduce wasteful steps and Wall Street Journal Article from June 21, 2005, featured improve information exchange the APSF, along with the ASA, as leading the way to • Use of secondary metrics (patient satisfaction surveys) improve patient safety in anesthesia. to support improvements/changes APSF NEWSLETTER February 2017 PAGE 57

Immediate Past President’s Report Highlights Accomplishments of 2016 by Robert K. Stoelting, MD

Since the majority of APSF activity in 2016 has Research occurred during my presidency, I am preparing The APSF Committee on Scientific Evaluation this annual “president’s report” over my name but chaired by Steven K. Howard, MD, received 46 let- as the “immediate past president” on the date this ters of intent and invited eight investigators to report appears. submit completed applications for studies beginning It was my privilege to serve as president of January 1, 2017. In October 2016, the committee rec- the Anesthesia Patient Safety Foundation (APSF) ommended funding three research awards totaling from October 1997–October 2016. At the October $598,004 (see Grant Awards report, page 64). 22, 2016, annual meeting of the APSF Board of In addition to the traditional research awards, Directors, Mark A. Warner was elected APSF APSF continues its support of the APSF Safety president. Dr. Warner is a current member of the Scientist Career Development Award (SSCDA) APSF Executive Committee and highly qualified ($150,000 over 2 years). The current recipients are to lead APSF in the years to come. Over the past Amanda R. Burden, MD (Cooper Medical School/ 19 years, I have experienced the unique opportu - Rowan University) and Ankeet Udani, MD (Duke nity to work with colleagues who approach anes- University). thesia patient safety with a passion and a volunteer spirit that is a credit to our profession The APSF Committee on Education and Retiring APSF President Robert K. Stoelting, MD. and the APSF vision that “no patient shall be Training, chaired by Maria van Pelt, CRNA, PhD, harmed by anesthesia.” with assistance of committee members, Brian J. APSF Board of Directors Cammarata, MD, Sandeep Markan, MD, and As in my previous annual reports, I believe it Workshop Lianne Stephenson, MD, sponsored the second is important to recognize that APSF, as an advo- annual APSF Resident Quality Improvement cacy group, does not write standards. Recommen- The APSF Board of Directors Workshop (QI) Recognition Program. Program submissions dations developed and promulgated by APSF are occurred on Saturday, October 22, 2016, and was consisted of a brief written narrative and video intended to assist professionals who are respon- moderated by Mark A. Warner, MD, and David J. describing the resident’s quality improvement sible for making health care decisions. Recom- Birnbach, MD. The topic for this 2-hour workshop topic. The 2016 resident winners were M. James mendations promulgated by APSF focus on was Conflicts in the Operating Room: Impact on Lozado, DO, University of Texas Medical Branch/ minimizing the risk to individual patients for rare Patient Safety. During this workshop, actual Galveston (Preoperative Anemia Protocol, 1st adverse events rather than necessarily on prac- operating room events that potentially impacted place) and Jon A. Holzberger, MD, University of tices that balance all aspects of population health patient safety were presented and the attendees Kentucky (Ampules and Glass Particle Contami- quality and cost. APSF does not intend for these were divided into small groups to offer comments nations, 2nd place). The resident winner’s recommendations to be standards, guidelines or on how the events were managed (see workshop department received a cash award of $1,000 and clinical requirements nor does application of summary, cover page). $500 for the first and second place awards, these recommendations guarantee any specific respectively outcome. Furthermore, these recommendations Distractions in the Anesthesia APSF is the largest private funding source for may be adopted, modified, or rejected according Work Environment: Impact on to clinical needs and restraints. APSF recognizes anesthesia patient safety research in the world. When the first grants were funded in 1987, fund- that these recommendations are subject to revi- Patient Safety ing for anesthesia patient safety was virtually sion as warranted by the evolution of medical APSF sponsored a consensus conference on unknown. Since 1987, APSF has awarded 109 knowledge, technology, and practice. patient safety implications of distractions in the grants for a total of more than $10,342,231. The anesthesia work environment on Wednesday, impact of these research grants is more far- Ellison C. Pierce, Jr., MD, September 7, 2016 (Phoenix, AZ) (see conference reaching than the absolute number of grants and summary, page 59). Patient Safety Memorial Lecture total dollars, as APSF-sponsored research has led A highlight of the opening session of the Large Anesthesia Groups and to other investigations and the development of a annual meeting of the American Society of cadre of anesthesia patient safety investigators. Anesthesiologists in Chicago, IL, on October 22, Practice Management 2016, was the fifth annual ASA/APSF Ellison C. Companies: How Can APSF APSF Newsletter Pierce, Jr., MD, Patient Safety Memorial Lecture Help Everyone Be Safe? Impact The APSF Newsletter (122,210 recipients includ- delivered by Alexander A. Hannenberg, MD. Dr. of Production Pressures on ing all members of the ASA, AANA, AAAA, Hannenberg’s topic was Patient Safety Beyond Our ASDA, and AOCA) continues its role as a vehicle Borders: Different but the Same (see lecture report, Patient Safety for rapid dissemination of anesthesia patient page 68). APSF sponsored a half-day meeting on patient safety information. Robert C. Morell, MD, retired This named lectureship continues to be part of safety implications of production pressures on as senior co-editor with the October 2016 issue of the annual ASA meeting and provides sustained Thursday, September 8, 2016, (Phoenix, AZ) with the APSF Newsletter, ending a 17-year association recognition for the vision and contributions to members of large anesthesia groups and represen- with the Newsletter as associate editor (1999–2001), anesthesia patient safety made by Dr. Pierce as the tatives from practice management companies (see editor (2002–2009), and senior co-editor (2010– founding president of APSF. conference report, pages 55). See “2016 Highlights,” Next Page APSF NEWSLETTER February 2017 PAGE 58

Numerous APSF Patient Safety Initiatives in 2016

“2016 Highlights,” From Preceding Page APSF also offers complimentary copies of the fol- the continuation of existing safety initiatives, and lowing educational DVDs (visit the APSF website funding for anesthesia patient safety research. The 2016). APSF thanks Dr. Morell for his many years for details, www.apsf.org) ability of APSF to provide research grants is par- of devotion to anesthesia patient safety and the • Opioid-Induced Ventilatory Impairment (OIVI): ticularly dependent on the level of financial sup- APSF Newsletter. Lorri A. Lee, MD, becomes senior port received from our financial sponsors. co-editor with the February 2017 issue of the APSF Time for a Change in the Monitoring Strategy Newsletter, and Steven B. Greenberg, MD, has been for Postoperative PCA Patients (Executive Sum- Online Donations mary, 7 minutes) appointed as co-editor. The link for online donations to APSF is • Perioperative Visual Loss (POVL); Risk Factors Communication http://www.apsf.org/donate.php. Contributions and Evolving Management Strategies may also be mailed to the Anesthesia Patient The APSF website design and content (www. (Executive Summary, 10 minutes) Safety Foundation, 1061 American Lane, Schaum- apsf.org) continues under the direction of APSF • APSF Presents Simulated Informed Consent burg, IL 60173-4973. executive vice president, George A. Schapiro. Online Scenarios for Patients at Risk for Perioperative donations to APSF are possible via the website. Visual Loss (POVL) (18 minutes) Recognition of Retiring and Richard C. Prielipp, MD, continues as the Patient New APSF Directors Safety Section editor for Anesthesia & Analgesia. Residual Muscle Relaxant- APSF thanks retiring Board Directors Susan Induced Weakness in the Carter, RN, Heidi Hughes, Terri G. Monk, MD, APSF-Sponsored Panels Postoperative Period: Roger A. Moore, MD, Robert K. Stoelting, MD, APSF sponsored a panel entitled More Myths of Shane Varughese, MD, and Robert J. White. APSF Anesthesia Patient Safety at the May 2016 annual Is it a Patient Safety Issue? welcomes new directors Douglas A. Bartlett, congress of the International Anesthesia Research APSF believes that residual neuromuscular Steven B. Greenberg, MD, Armi Holcomb, RN, Society in San Francisco, CA. The panel was mod- blockade in the postoperative period is a patient Rachel Hollingshead, RN, Steven K. Howard, MD, erated by Richard C. Prielipp, MD. safety hazard that could be addressed by and Marjorie P. Stiegler, MD. improved use of monitoring of the pharmacologic APSF sponsored a 1-hour session on “emer- effects of non depolarizing neuromuscular block- Concluding Thoughts gency manuals” at the September 2016 AANA ing drugs, particularly quantitative monitoring, annual meeting in Washington DC. The panel was As in the previous annual report, I wish to moderated by Maria Magro, CRNA, PhD. along with traditional subjective observations. The reiterate the desire of the APSF Executive February 2016 issue of the APSF Newsletter Committee to provide a broad-based consensus APSF will sponsor a panel entitled Production included an editorial and articles addressing this on anesthesia patient safety issues. Comments Pressures: Impact on Patient Safety on December 11 patient safety issue. and suggestions from all those who participate in during the 2016 annual meeting of the NYPGA. This the common goal of making anesthesia a safe panel will be moderated by Mark A. Warner, MD. Financial Support experience are welcomed. There still remains Prevention and Management of Financial support to the APSF from individu- much to accomplish and everyone’s participation als, specialty and components societies, and cor- and contributions are important. Operating Room Fires porate partners in 2016 has been most gratifying. Best wishes for a prosperous and rewarding 2017. To date, more than 8,400 individual requests This sustained level of financial support makes Robert K. Stoelting, MD for the complimentary copy of the Prevention and possible the undertaking of new safety initiatives, Immediate Past President Management of Operating Room Fires DVD (http:// www.apsf.org/resources_video.php) have been received. In addition, APSF has created a poster depicting the risks of alcohol-based preps (http:// The Anesthesia Patient Safety Foundation www.apsf.org/resources_safety.php). gratefully acknowledges an educational grant from Medication Safety in the Operating Room To date, more than 3500 individual requests for the complimentary copy of the 18-minute educa- tional DVD entitled, Medication Safety in the Operat- ing Room: Time for a New Paradigm (http://www. apsf.org/resources_video2.php) have been received. APSF will again address “medication www.medtronic.com safety” during an APSF-sponsored conference on September 7, 2017 in Phoenix, AZ. in full support of the Educational DVDs APSF/Medtronic Research Award (2017) In addition to the educational DVD on “oper- ating room fire safety” and “medication safety,” APSF NEWSLETTER February 2017 PAGE 59

Distractions in the Editors’ Note: The following article is reprinted and modified with permission from Preferred Physicians Medical’s (PPM) Risk Management Newsletter, Anesthesia and the Law (August 2014, Issue 39) on the medico- Anesthesia Work legal implications of distractions in the operating room. Environment: Impact on Patient Safety Distractions in the Operating Room: by Maria Magro, PhD, CRNA, and Matthew An Anesthesia Professional’s Liability? Weinger, MD by Brian J. Thomas, JD Distractions in the perioperative work environment can be attributed to many sources. We examine the increasing incidents of The Data distractions in the operating room that potentially When considering distractions, one must distinguish The potential for distractions in the OR and threaten patient safety and increase anesthesia those that are externally imposed from those that are other patient care areas is, of course, not limited to providers’ exposure to litigation and other internally motivated. Many of the externally PEDs. Reading in the OR, for instance, has been imposed distractions may be considered negative consequences. Specifically, distractions from the use of personal electronic devices in the debated for years. Moreover, research on the interruptions from the environment, other team impact of reading in the OR has been inconclusive. members, or technology. Internally motivated operating room for purposes not related to patient care are reportedly widespread in the anesthesia For example, a 2009 study examined the effects of distractions, those under the complete control of the reading in the OR on vigilance and workload anesthesia professional, may include patient care- community. Plaintiff attorneys are increasingly including allegations of negligent care caused by during anesthesia care and concluded there were related (looking up lab results on the EMR) or non- no scientific data that intraoperative reading and patient care-related (texting a friend about dinner distractions in the operating room in medical negligence litigation. In this issue, we highlight a non patient-related conversation during low- plans) activities. The anesthesia professional can case summary involving allegations of “distracted workload portions of the maintenance phase of choose to immediately react to, to defer responding doctoring,” the impact the evidence of distractions anesthesia adversely affect vigilance or multi-task- to, or to ignore internal and/or external distractions. 3 had on the evaluation of the case, and the ing. In fact, Slagle et al. suggested that reading All types of distractions can affect vigilance, significant challenges of overcoming that evidence may actually improve vigilance under some cir- situational awareness, and the ability to respond in the courtroom. We also offer some risk cumstances by keeping the anesthesia provider promptly to changes in the patient’s condition that, management strategies to assist anesthesia intellectually occupied and clinically stimulated, in turn, can pose a risk to patient safety. providers in avoiding and minimizing distractions thus averting boredom or mental inactivity. APSF believes that the role of both external in the operating room.1 Admittedly, little scientific data and research and self-induced distractions and potential Technology has advanced many aspects of the regarding the role of PEDs in the anesthesia envi- adverse effects needs to be addressed through practice of anesthesiology including, but not lim- ronment are currently available. The ASA Closed open discussion, education, research, the review ited to: immediate availability of patient medical Claims database reports a relatively small (13 of and potential revision of policy statements, and records, more efficient communication and con- 5822) number of claims related to distractions in 4 possibly other yet unidentified interventions. To nectivity, contemporaneous documentation, the OR. Given the delay associated with studying make progress in this area, APSF held a confer- improved legibility in the medical record, clinical closed claims, it is not surprising that, to date, the ence entitled “Distractions in the Anesthesia decision support, and data acquisition, manage- database currently reflects distractions such as Work Environment: Impact on Patient Safety” in ment and analyses. This same technology has printed materials, phone calls, and loud music. Phoenix, AZ on September 7, 2016. The Confer- also given rise to new patient safety and medico- Distraction-related claims, however, were judged ence’s goal was to 1) delineate the most impor- legal concerns.2 One emerging concern for many as substandard care in 91% of claims compared to tant types of external and self-induced anesthesia practices is the proliferation and use 50% of other claims. Settlements were made in distractions occurring in anesthesia profession- of personal electronic devices (PEDs)2 in the over 80% of the distraction-related claims for a als’ different work environments; 2) identify operating room (OR). median payment of $725,937. those distractions most likely to pose patient Given the degree to which PEDs have become Given the data currently available, most of the safety risks (i.e., high-risk distractions); and 3) a fixture in our daily lives, it is not surprising that commentators and cited authors agree that addi- develop recommendations for decreasing the anesthesia practices are confronted with the chal- tional scientific research and data are needed to incidence of high-risk distractions and to reduce lenge of how to effectively manage PEDs in the OR evaluate the impact of PEDs on anesthesia pro- the risk to patient safety when distractions of all and other patient care areas. From Preferred Phy- vider performance. Domino et al. suggested future types occur. A full report of the findings from this sicians Medical’s (PPM) vantage point as a medi- research should include sophisticated electronic important conference will appear in the next cal professional liability insurance company, any and human-factors methodology to consider the (June 2017) APSF Newsletter. distractions in the OR or patient care areas can effects of PEDs and other distracting activities on Matthew Weinger, MD, currently serves as Secre- jeopardize patient safety and/or negatively vigilance and performance during simulated and tary of the Executive Committee of the APSF and is impact PPM’s ability to successfully defend mal- actual anesthesia care.4 Professor of Anesthesiology at Vanderbilt University. practice lawsuits. The use of PEDs for personal or non patient-related activities increases the patient The Litigation Problem Maria Magro, PhD, CRNA, currently serves on the safety concern and compounds the challenge of Executive Committee of the APSF and chairs the Notwithstanding a lack of scientific data of dis- defending anesthesia providers in the event of an Committee on Education and Training of the APSF. She is tractions from PED use during anesthesia care, the adverse outcome. Distractions related to the use of potential for distraction is a growing concern in an Associate Clinical Professor and Nurse Anesthesia PEDs have recently surfaced in anesthesia litiga- Program Director at Northeastern University, Boston, MA. the medicolegal arena. In the last several years, tion, medical licensing board investigations, and PPM has defended multiple lawsuits involving Neither author has any disclosures related to as a basis for facilities to seek revocation of medi- this article. cal staff privileges. See “OR Distractions,” Next Page APSF NEWSLETTER February 2017 PAGE 60

Distractions in the Operating Room Continue

“OR Distractions,” From Preceding Page in ORs). In PPM’s own cases, defense counsel have should also be monitored for compliance to ensure allegations and evidence of distractions from the suggested that evidence of distraction increases the facility and medical staff are promoting a cul- personal use of PEDs in the OR and other patient the potential for multimillion dollar verdicts, ture of patient safety. care areas. In PPM’s experience, the mere sugges- possibly including punitive damages, against an tion that an anesthesia provider was distracted can allegedly distracted anesthesia provider involved “In addition to PED guidelines and policies, negatively impact PPM’s ability to defend the in a significant adverse outcome. from a risk management perspective, exercising anesthesia provider. Texting, “surfing” the Inter- good judgment and common sense is the best way net, social media, personal cell phone conversa- Other Consequences to avoid and minimize distractions in the OR from tions, or playing video games may also create a PPM is aware of several high-profile lawsuits PEDs,” according to Wade Willard, PPM’s Vice negative perception among other OR team mem- involving allegations and evidence of distractions President—Claims. Until additional scientific bers that the anesthesia provider was not paying in the OR that resulted in additional negative con- research and data are available to further evaluate attention to the patient. sequences including, but not limited to: this issue, PPM offers the following risk manage- ment strategies to reduce distractions in the OR. Additionally, plaintiff attorneys have no diffi- • Suspension and non-renewal of privileges at culty identifying anesthesiology experts who will practice facilities testify that the use of PEDs for non patient-related Risk Management Strategies that may activities in the OR and other patient care areas is • State medical licensing board investigations Reduce Distractions in the OR well below the standard of care and contrary to the and sanctions • Review and comply with practice facilities’ very hallmark of a competent and professional • Significant negative media coverage 3 PED guidelines and/or policies anesthesia provider­—vigilance. • Public relations challenges for the individual • Implement a “sterile cockpit”* “no interruption Plaintiff attorneys can be expected in such anesthesiologist and practice group zone”7 protocol during critical phases of cases to subpoena cell phone records and retain • Loss of employment procedures information technology (IT) experts to scour com- puter hard-drives to obtain metadata as evidence • National Practitioner Data Bank Reporting • Eliminate all discretionary sources of noise that the anesthesia provider was distracted in the during “sterile” periods What is the Solution? OR. Metadata, the “data about data” created by • Avoid loud or distracting music computer operating systems and applications, In response to the patient safety concerns allows plaintiff attorneys and their experts to related to distractions in the OR and other patient • Limit personal telephone calls and text determine, among other information, the exact care areas from the use of PEDs for non patient- messages to urgent or emergent situations date and time a web page was visited, a text or related purposes, several professional societies • Forward cell phone calls and transmissions to e-mail was sent or received, a cell phone call was and organizations have established position state- voice mail or memory made or received, the parties’ phone numbers and ments and guidelines to define appropriate PED • Silence ring tones the duration of the communication. Unlike dis- use in the OR.5-8 Other health care institutions, tractions in the OR allegedly caused by reading or residency programs, and anesthesia practice • Keep all telephone calls to a minimum and loud music, where the evidence is typically lim- groups have attempted to address this issue by brief as possible ited to other witnesses’ recollections of the events, establishing PED guidelines and policies. These • Limit OR internet access only to patient-care- the presence of PEDs in the OR provides plaintiff PED policies range from zero-tolerance (e.g., no related websites attorneys with a new evidentiary avenue. The PED use in OR) to more balanced policies that increased use of electronic discovery (or “e-discov- allow PED use for purposes directly related to • Avoid discretionary Internet-based activities ery”) allows metadata to serve as an “expert wit- patient care, online research and communications and browsing ness” to establish a very detailed timeline of between medical staff members, and verifying • Minimize nonessential conversation, electronic activities in the OR. surgery schedule assignment. especially during critical phases In PPM’s recent experience, courts have ruled Based on PPM’s experience defending litiga- • Limit interruptions from outside staff and that cell phone records and metadata are tion involving allegations of distractions in the others discoverable (i.e., parties to the litigation are OR, PPM recommends that anesthesia providers entitled to obtain that evidence) and such evidence work with their facilities to establish guidelines • Set an example—vigilance and focused may be admissible (i.e., parties to the litigation are and expectations for the entire OR team that bal- attention on the patient are paramount allowed to present that evidence to the jury to be ance the benefits of having access to PEDs in the • Speak up—let others know when their PED considered in reaching a verdict). PPM’s defense OR with the potential patient safety risks posed by use is distracting the OR team counsel have opined that allegations and evidence the inappropriate use of PEDs. PED guidelines of distractions from personal PED use during and policies should have the goal of educating the References: surgery could potentially shock, anger, and medical staff about distractions from PED use and inflame jurors (most of whom have little to no its potentially devastating effect on patient safety. 1. Thomas BJ. Asleep at the Wheel? Distractions in the knowledge of the day-to-day activities that occur Once implemented, PED guidelines or policies Operating Room. Anesthesia and the Law. August 2014, Issue 39. https://www.bing.com/search?q=ppm *The sterile cockpit concept is derived from aviation law that prohibits crewmembers from engaging in any activity except those duties +asleep+at+the+wheel&form=EDGNTC&qs=PF&cvi required for the safe operation of the aircraft during critical phases of flight, including taxi, takeoff, landing and all other flight d=6383327c93284b5ea67be1017fbc09b2&pq=ppm+asl operations conducted below 10,000 feet. “Sterile” periods in health care include, but are not limited to: induction and emergence of eep+at+the+wheel – last accessed December 4, 2016. anesthesia, critical events during the anesthetic and/or surgery and unanticipated events requiring additional OR team communication. See “OR Distractions,” Page 61 APSF NEWSLETTER February 2017 PAGE 61

Distractions in the Operating Room: A Case Study

“OR Distractions,” From Preceding Page later, the blood pressure dropped again and the The anesthesiology expert believed that the anesthesia provider increased the dopamine infu- anesthesia provider’s treatment of the The following case highlights some of the sig- sion and the phenylephrine boluses, at which hypotension met the standard of care, and he nificant challenges in defending anesthesia pro- point the systolic pressure rose to 110. He contin- appropriately communicated the patient’s viders in litigation involving allegations and ued to communicate his treatment choices to the changing vitals and hemodynamic status to the evidence of distractions in the OR: cardiologist throughout the procedure. Although cardiologist throughout the case. Further, he opined that the anesthesia provider does not have The case involved a 53-year-old male with the cardiologist was aware of the volatile shifts in a duty, or even an ability, to stop the procedure as medical history significant for atrial fibrillation the blood pressure, the anesthesia provider that decision is up to the cardiologist. and smoking who presented for an elective car- believed that he was not concerned because he diac atrial fibrillation ablation under general anes- continued with the ablation procedure. Despite the supportive expert witness, during thesia. The anesthesia provider performed the Approximately 15 minutes after the systolic discovery several nurses present in the OR testi- pre-anesthesia examination and assigned the pressure had risen to 110, it again dropped into fied the anesthesia provider was texting and read- patient an ASA III classification. the low 80s. Phenylephrine administration only ing articles on the Internet throughout the entire assisted in bringing it up for a few minutes, and case and even during the Code. The anesthesia Shortly after the induction of anesthesia and provider’s mobile phone records, however, con- placement of the endotracheal tube (ETT), the car- then it dropped into the 50s and would not increase in response to medications. The EKG firmed the anesthesia provider did not receive or diologist performed a transesophageal echocar- send a text during the procedure. In deposition diogram (TEE) that revealed an ejection fraction showed that the patient’s heart was generating electrical impulses, but it became clear that his testimony, the anesthesia provider acknowledged of 40–45%. Four minutes into the procedure, the he was looking at emails on his mobile phone patient’s systolic blood pressure dropped into the heart was not beating and he was experiencing pulseless electrical activity (PEA). during the procedure. The Internet log for the 80s. The anesthesia provider administered 10 mg computer in the cardiac catheter lab confirmed ephedrine, but the blood pressure stayed in the A Code was called and the cardiologist sus- that the anesthesia provider was accessing the 80s, and the pulse rate went up to 180 beats per pected the patient was experiencing a cardiac Internet at various times during the procedure. minute (bpm). The anesthesia provider informed tamponade. Multiple attempts to perform pericar- He last accessed the Internet approximately eight the cardiologist about the changes in vitals, but diocentesis were unsuccessful. Another cardiolo- minutes before the Code started. While there was the cardiologist indicated that he was not con- gist arrived to assist and was able to drain 450 to no specific evidence the anesthesia provider was cerned about the heart rate because he was trying 600 cc of fluid from the pericardial sac. The heart on the Internet during the Code, there was elec- to locate the source of the atrial fibrillation, and rate was restored and the patient was transferred tronic evidence that the anesthesia provider was there were no signs of ischemia on the EKG. to ICU. Unfortunately, the patient never recov- reading news stories on Yahoo and accessing his The anesthesia provider supported the blood ered from the Code, and was eventually taken off personal email account during the procedure. the ventilator and passed away. pressure with phenylephrine IV in 200 mcg Based on this evidence, defense counsel boluses. He informed the cardiologist of his treat- The patient’s wife and son sued the anesthe- opined a jury would likely react very negatively ment, and the cardiologist was aware of the sia provider, the cardiologist, and the hospital. to evidence that the anesthesia provider was events due to the monitors in front of him. The The patient’s family alleged the anesthesia pro- accessing the Internet and his personal email in anesthesia provider also lowered the anesthetic vider failed to: recommend that the cardiologist the cardiac catheter lab just moments before the inhalational agent () and gave fluid to stop the procedure due to the hemodynamic Code. In the face of testimony from multiple maintain blood pressure. The blood pressure was instability caused by the hypotension, properly nurses that the anesthesia provider was using a labile and required multiple interventions evaluate the cause of the hypotension that per- mobile phone throughout the procedure, and throughout the case. sisted for over two hours prior to the cardiac even during the Code, defense counsel was arrest, and maintain an acceptable blood pres- concerned PPM would be unable to persuasively The patient’s systolic blood pressure dropped sure. The patient’s family alleged further that the defend the anesthesia provider given this into the 60s on two occasions. The anesthesia pro- anesthesia provider’s negligence contributed to potentially inflammatory testimony. vider decided to begin a low-dose dopamine infu- the cardiac arrest resulting in hypoxic ischemic sion to help control the blood pressure, and he Based on defense counsel’s evaluation, the brain injury and death. notified the cardiologist of his activities. Once he anesthesia provider consented to settlement. The initiated the dopamine infusion, the systolic blood Defense experts retained on behalf of the parties participated in mediation and the case was pressure stabilized in the 90s. About 45 minutes anesthesia provider were supportive of his care. settled within the insurance policy limits.

“OR Distractions” From Preceding Page 5. American College of Surgeons. Statement on use of 8. Patterson P. Adopting a “no interruption zone” for cell phones in the operating room. Bull Am Coll Surg. patient safety. OR Manager 2013 Feb;29:20-2. 2. Cammarata BJ, Thomas BJ. Technology’s escalating 2008;93:33-34. impact on perioperative care: clinical, compliance, and Mobile medicolegal considerations. APSF Newsletter 6. American Association of Nurse Anesthetists. Device Use (formerly Position Statement Number 2.18) Brian J. Thomas, JD, is Vice President of Risk 2014;29:3-5. 2012. http://www.aana.com/resources2/ Management at Preferred Physicians Medical (PPM), a 3. Slagle JM, Weinger MB. Effects of intraoperative read- professionalpractice/Pages/Mobile-Information- ing on vigilance and workload during anesthesia care Technology.aspx professional liability company for anesthesiologists, in in the academic medical center. Anesthesiology 7. AORN. Position Statement on Managing Distractions Overland Park, KS. Mr. Thomas was an invited speaker 2009;110:275-83. and Noise During Perioperative Patient Care. 2014. at the recent APSF Conference on this topic. He has no 4. Domino KB, Sessler DI. Internet use during anesthesia See, http://www.aorn.org/Clinical_Practice/Posi- care: does it matter? Anesthesiology 2012;117:1156-8. tion_Statements/Position_Statements.aspx financial conflicts of interest to disclose. APSF NEWSLETTER February 2017 PAGE 62

2016 National Geriatric Surgical Initiatives by Stacie Deiner, MD, Lee A. Fleisher, MD, Roderic Eckenhoff, MD, and Mark Neuman, MD

This has been a landmark year for focused perioperative care and for research high- lighting the role of cognitive health on postopera- tive recovery among older adults. The American Society of Anesthesiologists (ASA) Committee on Geriatric Anesthesia has expanded to have an edu- cational track to provide content for the annual meeting and an abstracts committee with dedi- cated poster and oral presentation sessions. Geri- atrics committee members have been active on the national level to collaborate with ongoing efforts including the American College of Surgeons Coali- tion for Quality in Geriatric Surgery (CQGS) and the Brain Health Initiative (BHI), (Figure 1: National Geriatric Surgical Initiatives).

Figure 1: National Geriatric Surgical Initiatives Coalition for Quality in Geriatric Surgery (CQGS)

Primary Sponsor: American College of Surgeons responses. The plan is to roll out standards in 2019 to and 3) Can funders be educated about the gaps in Mission: to create a quality improvement program a core group of hospitals who participated in the knowledge regarding these conditions? A series of based on patient and caregiver centered outcomes initial visits. The eventual plan is to have standards workgroups have been identified and strategies to for excellence in geriatric care, which can be address each of these questions are currently under- Brain Health Initiative (BHI) implemented in a wide range of hospitals (academic, way. Primary Sponsor: The American Society for private, rural, etc.) across the country. The group consensus was that the public Anesthesiologists The BHI is sponsored by the ASA. The mission should be made aware of the current state of the of this group is to raise awareness regarding identi- evidence and that their engagement will result in Mission: to raise awareness regarding fication, prevention, and treatment of postoperative improved outcomes. It is clear that the risk of post- identification, prevention, and treatment of delirium for patients and providers. On the pro- operative delirium in an elderly surgical patient postoperative delirium for patients and providers vider side, this will involve dissemination and far exceeds many other complications that are implementation of best practice guidelines. In Sep- routinely discussed (heart attack, stroke, death). The CQGS is co-sponsored by the John A. Hart- tember, the ASA convened a multi-stakeholder The group believes that the public needs to be ford Foundation. The program’s mission is to create summit to address postoperative delirium, which informed regarding delirium for the purpose of a quality improvement program based on patient occurs frequently after major surgery in older education/reassurance and risk reduction when and caregiver centered outcomes. More than 50 adults. The summit included multiple specialty possible. There was general consensus that a cam- groups participate in the effort including patients societies who care for elderly patients undergoing paign should focus on raising patient awareness and caregiver advocacy groups, nursing, federal, surgery including (but not limited) to the American regarding the signs of delirium, identification by and private payers. About two years ago, an initial College of Surgeons, the American Association of patients and/or their families, education regard- discovery phase was carried out where team Orthopedic Surgeons, the American Geriatric Soci- ing the benefits of “prehabilitation” such as exer- members visited a diverse group of hospitals to ety (AGS), payers such as Center for Medicare and cise and nutrition, and preparing caregivers for discover the state of perioperative care for the older Medicaid Services, the Veterans Administration, the potential for longer term postoperative cogni- adult. Based on these visits and expert consensus, public advocacy groups including the American tive changes. The public awareness campaign will more than 200 standards were proposed for the pre, Association of Retired Persons, the Institute for also include information for caregivers about how intra, and postoperative period. Issues include Healthcare Improvement, and federal funders such best to help the elderly return to the baseline brain informed consent, preoperative cognitive screening, as the National Institute of Aging (NIA) and the health such as familiar objects and pictures to and increased use of geriatric best care practices Patient Centered Outcomes Research group. The assist with reorientation and a commitment to such as early mobilization and optimization of summit addressed three key questions: 1) Should assist with early mobilization. nutrition and sleep wake cycles. Once the standards the public be informed about the risks of surgery A similar campaign focusing on provider were assembled, the full group of stakeholders and anesthesia on postoperative cognition in the education across disciplines was discussed, which convened this fall. The group voted on the efficacy vulnerable brain and be informed of strategies to will highlight recommendations from the AGS and practicality of each measure and discussed the reduce that risk? 2) How can providers be informed Guidelines and the CQGS recommendations. The document in breakout groups. The next phase of the of and galvanized to implement strategies to reduce project will collate the individual and group postoperative delirium and cognitive dysfunction? See “Geriatric,” Next Page APSF NEWSLETTER February 2017 PAGE 63

Brain Health Initiative Seeks to Reduce the Incidence and Duration of Delirium in Patients TAKE THE SURVEY! “Geriatric,” From Preceding Page and breakout sessions, with the goal of identifying Hospital Power critical gaps in knowledge, and a deliverable of a mission of this campaign will be to disseminate research agenda that will be submitted to NIA, existing best practice to providers to reduce the Failure: National Institute of Neurological Disorders and risk of postoperative delirium and delayed cogni- Stroke (NINDS), National Institute of Mental tive recovery. Key provider stakeholders for this A Safety Hazard Health (NIMH) and National Institute of General educational initiative include nurses, pharmacists, Medical Sciences (NIGMS) for consideration of anesthesiologists, surgeons, internists, and pro- program announcements (PA) and request-for- Power failures affecting hospitals are a viders in training (residents and fellows). The ini- applications (RFA). The meeting will be interna- patient safety hazard, particularly in the tiative will work with groups that promote tional in scope, and the budget will include travel technology-rich environment of the operat- geriatric specialty training such as the Geriatrics funds for junior investigators. ing room and procedural areas. We recently for Subspecialists Initiative sponsored by the AGS published an article in the February 2016 and the ongoing Maintenance of Certification Pro- In summary, the ASA has initiated and is gram (MOCA) sponsored by the American Board working with other specialty groups to improve APSF Newsletter regarding how to manage 1 of Anesthesiology. the health of older adults after surgery. Many power outages in the operating room. The incidence of hospital power outages in the The provider initiative will create a toolkit for members of the Geriatrics Committee serve as liai- United States and their impact on patient medical professionals which will contain sugges- sons to these initiatives and communicate prog- care has not been studied systematically. As a tions about how to engage patients and families to ress to the ASA. The CQGS and BHI are major follow-up to that article and to better under- discuss delirium. The provider kit will also con- national efforts. The hope is that the two initiatives tain information regarding delirium. Information will work synergistically to advance scientific stand the scope of this problem, my col- would include pre- intra and postoperative strate- knowledge in this area to provide foundational leagues and I are asking anesthesiologists, gies to prevent delirium with emphasis on: knowledge for identification and treatment of anesthesia residents, and CRNAs in the delirium and ongoing evidence for best practice. United States to complete an 8-question, • preoperative identification of high risk patients The current timeline calls for CQGS roll out in 2 anonymous survey that should take less than (how to take a cognitive vital sign) years and the BHI provider materials to be avail- 5 minutes. Please fill out date and location • screening for polypharmacy able over the next 6 months. Both programs will information to the best of your recollection. need champions at academic and community cen- • awareness of Beers criteria medications (see Data will be reported in aggregate form with ters to roll out the best practices initiative. Provid- http://www.americangeriatrics.org/files/ no identifying information about survey par- ers, groups, and institutions who are interested in documents/beers/BeersCriteriaPublicTransla- ticipants or hospitals. You can access the becoming involved in the BHI should contact Lee tion.pdf, for more information) Fleisher ([email protected]). Progress survey by the following URL link: https:// • monitoring the brain during anesthesia from this year’s initiatives will be reported at next goo.gl/ngn1bx or by scanning the QR code below: • avoidance of antipsychotics year’s ASA meeting in Boston. • importance of nonpharmacologic sleep regi- Stacie Deiner, MD mens Associate Professor of Anesthesiology, Neurosurgery and Geriatrics & Palliative Care • early mobilization Department of Anesthesiology • Early Recovery After Surgery (ERAS) measures Mount Sinai Hospital to promote recovery New York, NY The kit will include a pathway or bundled Lee A. Fleisher, MD care for patients identified preoperatively as high Robert D. Dripps Professor and Chair of risk for delirium. The provider tool kit will also Anesthesiology and Critical Care contain an algorithm for dealing with agitated Perelman School of Medicine at the University of Thank you, in advance, for your participa- delirious patients and utilize materials such as Pennsylvania tion! short videos, printable pamphlets, review articles Roderic G. Eckenhoff, MD or guidelines, and proposed order sets. Grete H. Porteous, MD, Department of Vice Chair for Research and Austin Lamont Professor Anesthesiology, Virginia Mason Medical Center, Developing research priorities will require of Anesthesiology and Critical Care Seattle, WA. that investigators already engaged in this area, University of Pennsylvania Dr. Porteous has no financial conflicts of whether laboratory or clinical, meet, discuss, and Mark David Neuman, M.D., M.Sc. interest to disclose. reach consensus. This consensus is then presented Director, Penn Center for Perioperative Outcomes to funding agencies to consider targeted calls for Reference Research and Transformation (CPORT) proposals. Currently the working group led by Dr. Assistant Professor of Anesthesiology and Critical Care 1. Holland EL, Hoaglan CD, Carlstead MA, Roderick Eckenhoff will pursue NIH-supported Beecher RP, Porteous GH. How do I prepare for conference funding, in the next 6 to 9 months. If Assistant Professor of Medicine (Geriatrics) OR power failure? APSF Newsletter 2016;30:57- approved for funding, this meeting will occur in University of Pennsylvania 62. http://apsf.org/newsletters/html/2016/ February/ltr03-QA_ORPowerFailure.htm – last the fall of 2017, and involve 50 to 75 invited inves- The authors report no financial conflicts of interest accessed December 4, 2016. tigators working in the area for two days of talks associated with this article. APSF NEWSLETTER February 2017 PAGE 64 2017 APSF Grant Recipients by Steven K. Howard, MD

We are pleased to report on this year’s grant place a noninvasive blood pressure (NIBP) cuff in continuing to administer medications ipsilateral recipients in this edition of the Newsletter. The on the same extremity and proximal to an intra- to an NIBP cuff without risk of unintended conse- APSF’s mission statement explicitly includes the venous (IV) catheter including contralateral quences. However, if this study finds that extrava- goal to continually improve the safety of patients upper extremity injuries, dialysis fistulas, previ- sation occurs readily and redistribution is during anesthesia care by encouraging and con- ous lymph node dissection, or inability to find prolonged, then the publication of this informa- ducting safety research and education. Since 1987, alternate sites for IV placement. The common tion could alter practice habits for all providers the APSF has funded safety projects totaling over assumption is that, as long as the IV catheter and improve safety for all patients. NDNMBAs 10 million dollars. remains completely within the intact vein and are unique drugs that can directly compromise large volumes of medication are not injected patient safety when their effects are not com- In 2016, the APSF investigator-initiated grant against complete and prolonged veno-occlusion pletely terminated at the conclusion of the anes- program had 46 letters of intent (LOIs). Members (as is intentionally done for an IV regional anes- thetic. It is essential to recognize and address any of the APSF Scientific Evaluation Committee thetic), the medications administered through the potential causes of residual neuromuscular block- reviewed and invited the top eight scoring LOIs to IV catheter will remain intravenous as well. ade in the postoperative period. submit full proposals—seven full proposals were Recent case reports, however, suggest that medi- submitted for final review and discussion on Octo- Funding: $149,976 (January 1, 2017—Decem­ - cations administered through an IV catheter ber 22, 2016, at the ASA Annual Meeting in Chi- ber 31, 2017). This grant was designated as the distal to transient veno-occlusion, as seen in an cago, IL. Three proposals were recommended to APSF/American Society of Anesthesiologists inflating or inflated NIBP cuff, may be at risk for the APSF Executive Committee for funding and all (ASA) President’s Research Award. extravasation and subsequent redistribution received unanimous support. This year’s grant resulting in extended release of medication. For recipients were Seth Herway, MD, MS, from the most medications, extended release of small Department of Anesthesiology at the University of amounts of the drug would result in little to no California San Diego; Michael Mazzeffi, MD, physiologic implications for the patient. How- MPH, from the Department of Anesthesiology at ever, in the case of nondepolarizing neuromuscu- the University of Maryland; and Janet van lar blocking agents (NDNMBAs), extended Vlymen, MD, FRCPC, from the Department of release of even very small amounts could result Anesthesiology and Perioperative Medicine at in complications, compromising the periopera- Queen’s University in Kingston, Ontario, Canada. tive safety of potentially all postoperative The principal investigators of this year’s APSF patients and certainly groups with impaired grant provided the following description of their muscular strength or respiratory physiology. proposed work. Aims: This project will detect extravascular accumulation of an NDNMBA surrogate fluores- cent molecule, indocyanine green (ICG), when injected against transient veno-occlusion in healthy Michael Mazzeffi, MD, MPH volunteers using a novel real-time, noninvasive, in Assistant Professor of Anesthesiology vivo fluorescent imaging technique. This surrogate Department of Anesthesiology will be administered through an IV distal to an University of Maryland inflated blood pressure cuff in healthy volunteers. A Dr. Mazzeffi’s grant is titled “High-flow nasal Fluobeam® Clinical System device (Fluoptics, cannula oxygen in patients having anesthesia for Grenoble, France), a noninvasive, FDA-approved endoscopy.” device that can detect, in real-time, fluorescence emitted from tracer molecules such as ICG, will be Background: High-flow nasal cannula oxygen used to determine the extent of ICG extravasation provides several advantages over traditional nasal that occurs when injected distal to a transiently cannula oxygen including reduced work of breath- inflated NIBP cuff and the time course of redistribu- ing, reduced anatomic dead space, and continuous Seth Herway, MD, MS tion of extravasated medication. This study will positive airway pressure, which improves oxygen- demonstrate conditions under which extravasation ation. Traditional nasal cannula oxygen is limited Assistant Professor of Anesthesiology occurs, the relative proportion of injected medica- by the fact that it can only increase the inspired Department of Anesthesiology tion that extravasates, and the time period required oxygen concentration to around 35%. Alterna- University of California San Diego for redistribution of the extravasated medication. tively, high-flow nasal cannula can deliver Dr. Herway’s grant is titled “An insidious inspired oxygen concentrations as high as 91%. Implications: Regardless of the outcome, the cause of postoperative weakness: peripheral High-flow nasal cannula oxygen has also been information from the study will be useful to the stores of neuromuscular blocking agents caused by shown to increase the distending pressure in the anesthesia community and improve perioperative unrecognized extravasation when injected distal upper airway, which may decrease upper airway safety. If this study finds that extravasation does to a NIBP cuff.” obstruction in anesthetized patients and improve not readily occur or redistribution is rapid, then ventilation. At the present time, high-flow nasal Background: There are a number of situations anesthesia providers will have the first rigorously where an anesthesia professional may elect to documented evidence that they can be confident See “2017 Grants,” Next Page APSF NEWSLETTER February 2017 PAGE 65

2017 APSF Grant Recipients Focus on a Wide Variety of Safety Topics

“2017 Grants,” From Preceding Page It has been widely demonstrated that anesthesia professionals often inadvertently contaminate their cannula has been used primarily in critical care, workspace, including medication preparation areas, but it may also be useful in patients receiving deep during routine clinical practice. It is possible that the sedation or general anesthesia without a con- rubber diaphragm of medication vials could become trolled airway. One group of patients that com- unknowingly contaminated with bodily fluids con- monly receives general anesthesia without a taining a significant viral load if the anesthesia pro- controlled airway is patients undergoing gastroin- fessional was caring for an HCV-infected patient. If testinal (GI) endoscopy. Each year, millions of the anesthesia professional then accessed that vial with a sterile needle and syringe, they might unin- endoscopies are performed in the United States tentionally contaminate the medication, which could and a substantial number of patients experience be administered to subsequent patients. Not only has hypoxemia while under anesthesia. High-flow HCV been shown to remain viable on inanimate sur- nasal cannula oxygen offers an opportunity to faces for up to 6 weeks, studies have also shown that potentially decrease hypoxemia and improve Janet van Vlymen, MD, FRCPC HCV remains stable in commonly used anesthetic medications for days to weeks. patient safety. Associate Professor of Anesthesiology Aims: The specific aims of this single center ran- Department of Anesthesiology & Perioperative Medicine Aims: Using the most current and appropriate virology methods available for HCV research, we domized controlled trial are to determine whether Queen’s University, Kingston, Ontario, Canada will test the hypothesis that HCV can be trans- high-flow nasal cannula oxygen delivery can Dr. van Vlymen’s grant is titled “Can health- ferred from the outer diaphragm of a medication reduce hypoxemia, hypercarbia, and hypotension care-associated hepatitis C virus outbreaks vial into the medication itself when penetrated in patients having anesthesia for GI endoscopy. occur when intravenous medication vials are with a sterile needle and syringe. We will also Patients who participate in the study will be ran- accessed with clean needles and syringes for use examine the stability of HCV within a number of in multiple patients?” domly assigned to receive the current standard of commonly used anesthetics and determine what cleansing practices are required to eliminate this care (regular-flow nasal cannula oxygen) or to have Background: Healthcare-associated hepatitis transmission risk. high-flow nasal cannula oxygen delivery. Patients C virus (HCV) outbreaks with patient-to-patient transmission continue to occur across North will have their blood carbon dioxide levels mea- Implications: Anesthesia professionals are America despite the widespread implementation leaders in patient safety, but are often reluctant to sured during their procedure using a noninvasive of infection control guidelines. In some circum- follow guidelines blindly without evidence to jus- monitor. They will also have standard anesthetic stances, contaminated medications, administered tify the recommendations. However, when pre- monitoring during the procedure and study out- by the anesthesia provider, have been found to be sented with scientific proof, we are quick to adopt comes will be compared between the two groups. the most likely source of transmission. Although it change and become advocates educating other health care practitioners. Without awareness of the Implications: Although serious complications is often assumed that contamination occurred from reusing needles or syringes, investigations true dangers of medication practices that are from hypoxemia or hypercarbia are rare during often find no evidence for this and the practitio- intended to reduce waste and expense, adherence anesthesia for GI endoscopy, near-miss events ners involved have adamantly denied the practice. to safe medication practices will never be may be frequent. A review of our own center’s achieved. With proof that this mode of transmis- While it is clearly unacceptable to reuse nee- data over the last year demonstrated that as many sion occurs and with appropriate knowledge dles or syringes, it remains a recognized practice as 18% of patients may experience hypoxemia translation strategies, changes in clinical practice to share multi dose medication vials between during these procedures. If high-flow nasal can- surrounding the re-use of medication vials for patients, provided sterile needles and syringes are multiple patients will be achievable. nula is found to reduce hypoxemia and hypercar- used with aseptic technique for each access. Pub- Funding: $148,235 (January 1, 2017—Decem- bia, this could prevent many “near-miss” events lished medication safety guidelines recommend ber 31, 2018). This grant was designated as the per year in the United States and substantially that vials should be single-use whenever possible. APSF/Medtronic Research Award. Dr. van improve patient safety. Also, a large multicenter The guidelines indicate that if multi-dose vials are Vlymen is also the recipient of the Ellison C. used on more than one patient, they should be trial would be merited as many patients could be “Jeep” Pierce, Jr., MD Merit Award, which pro- stored outside of the immediate patient care area impacted by the study’s findings. vides an additional, unrestricted amount of $5,000. and the diaphragm cleaned with 70% alcohol with Funding: $150,000 (January 1, 2017—Decem- friction and drying. Although some institutions Dr. Howard is Professor of Anesthesiology, Periop- ber 31, 2018). This grant was designated as the may be able to ensure strict compliance to these erative and Pain Medicine at Stanford University APSF/American Society of Anesthesiologists standards, unfortunately, this has not been univer- School of Medicine and Chair of the APSF Committee (ASA) Endowed Research Award. sal practice. on Scientific Evaluation. Please Support Your APSF—Your Voice in Patient Safety

Please make checks payable to the APSF and mail donations to Anesthesia Patient Safety Foundation (APSF), 1061 American Lane, Schaumburg, IL 60167-4973 APSF NEWSLETTER February 2017 PAGE 66

Anesthesia Patient Safety Foundation

CORPORATE SUPPORTER PAGE

APSF is pleased to recognize the following corporate supporters for their exceptional level of support of APSF

Medtronic is committed to creating innovative medical solutions for better patient outcomes and delivering value through clinical leadership and excellence in everything we do. www.medtronic.com

Today’s Merck is a global health care leader working to help the world be well. Through our prescription , vaccines, and biologic therapies, we operate in more than 140 countries to deliver innovative health solutions. www.merck.com

CareFusion combines technology and intelligence to Preferred Physicians Medical providing malpractice protection measurably improve patient care. Our clinically proven exclusively to anesthesiologists nationwide, PPM is products are designed to help improve the safety and cost anesthesiologist-founded, owned and governed. PPM is a leader of health care for generations to come. www.carefusion.com in anesthesia-specific risk management and patient safety initiatives. www.ppmrrg.com

GE Healthcare Masimo is dedicated to helping anesthesia professionals provide (gemedical.com) optimal anesthesia care with immediate access to detailed clinical intelligence and physiological data that helps to improve anesthesia, blood, and fluid management decisions. www.masimofoundation.org

PharMEDium is the leading national provider of outsourced, The Doctors Company Foundation was created in 2008 by compounded sterile preparations. Our broad portfolio of prefilled The Doctors Company, the nation’s largest insurer of medical O.R. anesthesia syringes, solutions for pumps, liability for health professionals. The purpose is to support epidurals, and ICU medications are prepared using only the patient safety research, forums, pilot programs, patient safety highest standards. www.pharmedium.com education, and medical liability research. www.tdcfoundation.com APSF NEWSLETTER February 2017 PAGE 67

Online donations accepted at Anesthesia Patient Safety Foundation www.apsf.org Corporate Donors Founding Patron ($425,000) American Society of Anesthesiologists (asahq.org) Sustaining Professional Organization Grand Patron Sustaining Patron Supporting Patron ($150,000 and higher) ($150,000 and higher) ($100,000 and higher) ($50,000–$99,999) American Association of Medtronic National Board for Certification and Merck and Company Nurse Anesthetists (aana.com) (medtronic.com) Recertification of Nurse Anesthetists (merck.com) (NBCRNA) (nbcrna.com) Sponsoring Patron ($30,000 to $49,999) Benefactor Patron ($20,000 to $29,999) Becton Dickinson Preferred Physicians (bd.com) Medical Risk Retention GE Healthcare Masimo Foundation for Ethics, Innovation and PharmMEDium Services The Doctors Company Foundation Group (ppmrmg.com) (gemedical.com) Competiton in Healthcare (masimofoundation.org) (pharmedium.com) (tdcfoundation.com)

Patron ($10,000 to $19,999) Dräger Medical Systems (draeger.com) Smiths Medical (smiths-medical.com) Medical Protective (medpro.com) Participating Associations Baxter Anesthesia and Critical Care Eagle Pharmaceuticals (eagleus.com) Sponsoring Donor Omnicell (omnicell.com) ($1,000 and above) (baxter.com) Fresenius-Kabi (fresenius-kabi.us) ($1,000 to $4,999) 3M Infection Prevention Division American Dental Society of Anesthesiology Spacelabs Healthcare (spacelabs.com) Mindray North America (mindray.com) AMBU, Inc (ambu.com) (3m.com/infectionprevention) Research Foundation Teleflex Medical (teleflex.com) Nihon Kohden America, Inc. B. Braun Medical, Inc. (bbraun.com) Corporate Level Donor American Society of Anesthesia Technologists Sustaining Donor (nihonkohden.com) Codonics (codonics.com) ($5,000 to $9,999) Pall Corporation (pall.com) GCP Applied Technologies (gcpat.com) ($500 to $999) and Technicians (asatt.org) ClearLine MD (clearlinemd.com) Respiratory Motion Hospira, a Pfizer Company (hospira.com) Paragon Service (paragonservice.com) American Society of Dentist Anesthesiologists Cook Medical (cookgroup.com) (respiratorymotion.com) Intersurgical, Inc. (intersurgical.com) Wolters Kluwer (lww.com) (asdahq.org) Anesthesia Practice Platinum Level Sponsor Gold Level Sponsor ($5,000 to $14,999) ($15,000 and higher) North American Partners in Anesthesia (NAPA) PhyMED Healthcare Group (phymed.com) Management MEDNAX (mednax.com) (napaanesthesia.com) Sheridan Healthcorp (shcr.com) Companies US Anesthesia Partners (usap.com) NorthStar Anesthesia

Community Donors (includes Individuals, Anesthesia Groups, Specialty Organizations, and State Societies) Benefactor Sponsor American Association of Oral and Oklahoma Society of Marilyn Barton (in memory of Maine Society of Anesthesiologists South Carolina Society of ($5,000 to $14,999) Maxillofacial Surgeons Anesthesiologists Darrell Barton) Maryland Society of Anesthesiologists Anesthesiologists Alabama State Society of American Dental Society of Oregon Society of Anesthesiologists Amanda R. Burden, MD Edwin Mathews, MD Spiro Spankis, MD Anesthesiologists Anesthesiology Research Frank J. Overdyk, MSEE, MD (in Michael P. Caldwell, MD Timothy McCall Ronald S. Stevens, DO American Academy of Foundation honor of Robert K. Stoelting, MD) Keith J. Chamberlin, MD Russell K. McAllister, MD Steven L. Sween, MD Anesthesiologist Assistants American Society of PeriAnesthesia Srikanth S. Patankar, MD Lillian K. Chen, MD Gregory B. McComas, MD James F. Szocik, MD American Society for Health System Nurses A. William Paulsen, PhD, AA-C Joan M. Christie, MD Sharon M. Merker, MD Joseph W. Szokol, MD Pharmacists Anesthesia Associates of Columbus, GA Pennsylvania Association of Nurse Marlene V. Chua, MD Mississippi Society of Dr. and Mrs. Stephen J. Thomas Daniel J. Cole, MD Anesthesia Associates of Ann Arbor Anesthesia Consultants Medical Anesthetists Anesthesiologists University of Maryland Colorado Society of Anesthesiologists Anaesthesia Associates of Casey D. Blitt, MD James M. Pepple, MD Roger A. Moore, MD Anesthesiology Associates Massachusetts Physician Specialists in Anesthesia Charles E. Cowles, MD Robert C. Morell, MD Andrea Vannucci, MD Raymond J. Boylan, Jr., MD Glenn DeBoer, MD Indiana Society of Anesthesiologists (Atlanta, GA) Soe Myint, MD Drs. Maria and Frederick van Pelt Sorin J. Brull, MD John K. Desmarteau, MD Minnesota Society of California Society of Anesthesiologists Rhode Island Society of Joseph J. Naples, MD Susan A Vassallo, MD (in honor of Anesthesiologists Andrew E. Dick, MD Anesthesiologists Dr. and Mrs. Robert A. Caplan John B. Neeld, MD (in honor of Robert Neelakantan Sunder, MD) Frank B. Moya, MD, Continuing Carol E. Rose, MD Peggy G. Duke, MD Frederick W. Cheney, MD K. Stoelting, MD) Sandhya Rani Vinta, MD Education Programs Drs. Ximena and Daniel Sessler Marcel E. Durieux, PhD, MD Connecticut State Society of Richard P. Dutton, MD, MBA Nevada State Society of Virginia Society of Anesthesiologists Valley Anesthesiology Foundation Society for Airway Management Anesthesiologists Stephen B. Edelstein, MD Anesthesiologists Joyce A. Wahr, MD Travis Wolther (USAP) Society for Ambulatory Anesthesia Jan Ehrenwerth, MD New Hampshire Society of Thomas L. Warren, MD Jeffrey B. Cooper, PhD Society for Obstetric Anesthesia and Sustaining Sponsor Michael R. England, MD Anesthesiologists WebMD (in honor of Robert C. Morell, Dr. and Mrs. Robert A. Cordes Perinatology ($2,000 to $4,999) District of Columbia Society of Cynthia A. Ferris, MD New Jersey State Society of MD and Richard C. Prielipp MD) Society for Pediatric Anesthesia Anesthesiologists Academy of Anesthesiology Anesthesiologists Dragos Galusca, MD Matthew B. Weinger, MD Patient Safety and Education Fund New Mexico Society of American Osteopathic College of Deborah J. Culley, MD Georgia Association of Nurse Andrew Weisinger, MD Anesthesiologists South Dakota Society of Anesthesiologists David S. Currier, MD Anesthetists James M. West, MD Arizona Society of Anesthesiologists Anesthesiologists William P. Gibson, MD Mark C. Norris, MD John H. Eichhorn, MD Wichita Anesthesiology, Chartered Madison Anesthesiology Consultants Spectrum Medical Group of Ian J. Gilmour, MD Michael A. Olympio, MD G. Edwin Wilson, MD Gerald Feldman Massachusetts Society of Portland, ME Goldilocks Anesthesia Foundation Docu Onisei, MD Philip J. Zitello, MD David M. Gaba, MD Anesthesiologists Stockham-Hill Foundation Richard Gnaedinger, MD Susan K. Palmer, MD Ronald L. Katz Family Foundation Georgia Society of Anesthesiologists TEAMHealth Michiana Anesthesia Care Joel G. Greenspan, MD John L. Pappas, MD Jonathan D. Griswold, MD Michigan Society of Anesthesiologists James D. Grant, MD Tejas Anesthesia Allen N. Gustin, MD Stephen D. Parker, MD Michael D. Miller, MD Steven B. Greenberg, MD Texas Association of Nurse Raafat S. Hannallah, MD Mukesh K. Patel, MD In Memoriam New York State Society of Alexander A. Hannenberg, MD Anesthetists Timothy N. Harwood, MD Pennsylvania Association of Nurse In memory of W. Darrell Burnham, Anesthesiologists (Pierce Research Fund) Texas Society of Anesthesiologists Gary R. Haynes, MD Anesthetists MD (Mississippi Society of North Carolina Society of Illinois Society of Anesthesiologists TCAA-Associated Anesthesiologists Simon C. Hillier, MD Lee S. Perrin, MD Anesthesiologists) Anesthesiologists Iowa Society of Anesthesiologists Division Glen E. Holley, MD Drs. Beverly and James Philip In memory of Donna M. Holder, MD Steven K. Howard, MD Old Pueblo Anesthesia Group Kaiser Permanente Nurse Washington State Society of Tian Hoe Poh, MD (Karen P. Branam, MD) Society of Academic Anesthesiology Kenward B. Johnson, MD Anesthetists Association (KPNAA) Anesthesiologists Richard C. Prielipp, MD In memory of Paul C. Kidd, MD Associations James J. Lamberg, DO Wisconsin Society of Kansas State Society of (Texas Society of Anesthesiologists) Anesthesiologists Neela Ramaswamy, MD Springfield Anesthesia Service at Kentucky Society of Anesthesiologists Anesthesiologists In memory of Russell Morrison, Tom C. Krejcie, MD Mark Ramirez, MD Baystate Medical Center Lorri A. Lee, MD CRNA (Jeanne M. Kachnij, CRNA) Robert K. Stoelting, MD Sponsor ($200 to $749) Gopal Krishna, MD Christopher Reinhart, CRNA Anne Marie Lynn, MD In memory of Ellison C. Pierce, Jr., Tennessee Society of Anesthesiologists Anesthesia Associates of Kansas City Catherine M. Kuhn, MD Jennifer Root, MD Missouri Society of Anesthesiologists MD (Alexander A. Hannenberg, Mary Ellen and Mark A. Warner Anesthesia Associates of Northwest Cathleen Peterson-Layne, MD, PhD Jo Ann and George Schapiro Nebraska Society of Anesthesiologists Dayton, Inc. Paul G. Lee, MD Sanford H. Schaps, MD MD) Contributing Sponsor Northwest Anesthesia Physicians Shane Angus, AA-C Kevin and Janice Lodge Stephen J. Skahen, MD In memory of William Roady, MD ($750 to $1,999) Ohio Academy of Anesthesiologist Donald E. Arnold, MD Michael K. Loushin, MD Jan Smith (James S. Hicks) Affiliated Anesthesiologists of Assistants Balboa Anesthesia Group Philip and Christine Lumb Dr. David Solosko and Ms. Sandra In memory of Jack D. Stringham, MD Oklahoma City, OK Ohio Society of Anesthesiologists Robert L. Barth, MD Alfred E. Lupien, PhD, CRNA Kniess (Gregory Peterson, MD) Note: Donations are always welcome. Donate online ( http://www.apsf.org/donate_form.php)or mail to APSF, 1061 American Lane, Schaumburg, IL 60167-4973. (Donor list current through December 31, 2016.) APSF NEWSLETTER February 2017 PAGE 68

2017 EC Pierce Lecture: Safety Beyond Our Borders by Steven Greenberg, MD, FCCP, FCCM

Alexander A Hannenberg, MD, presented the outcomes by facilitating teamwork and communi- Ellison C. Pierce Jr., MD, ASA/APSF Patient cation among the surgical team providers. He Safety Memorial Lecture at the 2016 ASA Annual also suggested that equipment that is donated Meeting in Chicago, IL, entitled “Safety Beyond from other countries should have the same qual- Our Borders: Different but the Same.” Dr. ity and meet the same standards as in those Hannenberg is clinical professor of Anesthesiol- developed nations that are using them. Dr. ogy at Tufts University School of Medicine in Hannenberg finished his poignant lecture by Boston, MA, and associate chair of Anesthesiol- articulating the importance of ensuring patient ogy at Newton-Wellesley Hospital in Newton, safety as surgical access increases in developing MA, and a past president of ASA (2010). He pro- nations.2 vided some staggering statistics surrounding inadequate surgical care in developing nations Steven Greenberg currently serves as Co-Editor of with approximately 5 billion people lacking any the APSF Newsletter and Vice Chairperson, access to surgical care, and an additional 7 million Education in the Department of Anesthesiology at who are seriously injured or die from surgical- 1 NorthShore University HealthSystem, Evanston, IL. related complications. He noted that the impres- He is Clinical Associate Professor in the Department of sive increase in global surgical care between 2004 Anesthesiology/Critical Care at the University of to 2012 has made surgery a more frequent event Chicago, Chicago, IL. worldwide than childbirth, but experts are con- Alexander A. Hannenberg, MD cerned that this rapid increase will create more Reference: victims of unsafe surgery. Dr. Hannenberg com- mented that those who live in inadequate health 1. Alkire BC, Raykar NP, Shrime MG, et al. Global nication, insufficient provider training, and lack access to surgical care: a modelling study. The Lancet care systems may be exposed to a 100 to 1,000 fold 2 of basic resources. 2015; 3: e16-e323. greater risk of preventable death with surgery than those in industrialized nations.1,2 He Dr. Hannenberg highlighted some measures 2. “Pierce lecturer addresses challenges to patient safety in developing world.” (2016, October 23). acknowledged that unsafe anesthesia practices to reduce the potential for unsafe surgery and Retrieved from: http://asa-365.ascendeventmedia. anesthesia. He noted that the World Health Orga- significantly contribute to this unintended harm. com/anesthesiology-2016-daily/pierce-lecturer- He believes the key contributory factors for this nization’s surgical safety checklist has been dem- addresses-challenges-to-patient-safety-in-develop- heightened risk are poor teamwork and commu- onstrated to significantly improve surgical ing-world

APSF Website Offers Online Educational DVDs Visit the APSF website (www.apsf.org) to view the following DVDs and request a complimentary copy.

• Opioid-Induced Ventilatory Impair- • Perioperative Visual Loss (POVL): • APSF Presents Simulated Informed ment (OIVI): Time for a Change in the Risk Factors and Evolving Manage- Consent Scenarios for Patients at Risk for Monitoring Strategy for Postoperative ment Strategies (10 minutes) Perioperative Visual Loss from Ischemic PCA Patients (7 minutes) Optic Neuropathy (18 minutes) APSF NEWSLETTER February 2017 PAGE 69

Letter to the Editor: Don’t Forget the Routine Endotracheal Tube Cuff Check! by Christina Brown, MD, and Laura Cavallone, MD

To the Editor: were confirmed. Although the ETT pilot balloon cuff bulb, holding appropriate inflating pressure We are writing to call attention to the often was noted to be appropriately tense to the touch, a in the presence of a major air leak) confounded the under-appreciated importance of checking the small amount of air was added to the cuff. How- diagnostic process, while a preoperative check of ever, a major air leak persisted. At this point the endotracheal tube (ETT) prior to the start of the the ETT would have unequivocally detected the anesthesiology team decided to proceed with procedure. Routine checks of the ETT integrity defect in the cuff tube. exchanging the ETT, which was successful. The air and functionality before insertion used to be the As newer manufacturing techniques have leak resolved with the new ETT in place and the standard of care, but the practice is becoming less decreased the occurrence of ETT defects, routine cuff inflated. Upon closer inspection of the ETT common, although it is still recommended in cur- assessments of the ETT cuff integrity prior to use that had been removed from the airway, there rent ASA guidelines.1 have become increasingly less common among pro- appeared to be a defect in which the air injected viders. The ASA recommends checking all ETT cuffs into the pilot balloon did not reach the cuff (see After induction of anesthesia, a 71-year-old prior to their use.1 While rare, endotracheal tube cuff Figures 1 and 2). female patient undergoing a parotidectomy was defects are a known cause of endotracheal tube leaks nasally intubated with a TaperGuard 6.5 Nasal Air leaks are a common yet critical problem which often necessitate endotracheal tube exchange. ® RAE tube using a C-MAC KARL STORZ GmbH that require quick diagnosis. A systematic ETT exchange could pose significant risk to patients & Co. KG Mittelstraße 8, 78532 Tuttlingen, Ger- approach to evaluation of air leaks is recom- especially in the case of the patient with a difficult many, video-laryngoscope. Intubation was atrau- mended to ensure rapid evaluation and identifica- airway. In our case, had the endotracheal tube been matic and the cuff was inflated with 10 ml of air. tion of underlying issues. One such approach checked prior to the start of the case, the defect could After cuff inflation, a persistent significant air leak entails beginning at the patient and following the have been easily identified which would have obvi- was noted (> 1 L/min in volume controlled venti- circuit to the machine. In this case, an air leak was ated the need for tube exchange. lation modality). The integrity of the entire breath- audible from the patient’s oropharynx, which led ing circuit and correct positioning of the ETT the team to identify the problem quickly. How- Christina M. Brown, MD, Resident, Department of between the vocal cords with direct laryngoscopy ever, the presence of contradictory findings (tense Anesthesiology, Washington University in St. Louis, MO. Laura F. Cavallone, MD, Associate Professor, A B Department of Anesthesiology, Washington University in St. Louis, MO. None of the authors have conflicts of interest relating to the publication of this paper.

Reference 1. Statement on the Standard Practice for Infection Preven- C D tion and Control Instruments for . American Society of Anesthesiology, Committee of Origin: Committee on Quality Management and Depart- mental Administration (QMDA). Approved by the ASA House of Delegates on October 20, 2010, and last amended on October 28, 2015. Retrieved from: http:// www.asahq.org/~/media/sites/asahq/files/public/ Figure 1. Comparison of normal and defective endotracheal tubes. A) Normal endotracheal tube with 10 ml of air resources/standards-guidelines/statement-on-stan- instilled into cuff. B) Defective cuff with 10 ml air instilled into cuff. C) Pressure gauge attached to pilot balloon of dard-practice-for-infection-prevention-for-tracheal-intu- normal cuff reading 30 mmHg with cuff inflated. D) Pressure gauge attached to pilot balloon of defective cuff with bation.pdf. reading of 30 mmHg with cuff not appropriately inflated.

A B APSF Executive Committee Invites Collaboration From time to time the Anesthesia Patient Safety Foundation reconfirms its commitment of working with all who devote their energies to making anesthe- sia as safe as humanly possible. Thus, the Foundation invites collaboration from all who administer anesthe- sia, and all who provide the settings in which anesthe- sia is practiced, all individuals and all organizations who, through their work, affect the safety of patients receiving anesthesia. All will find us eager to listen to Figure 2. Comparison of distance traveled by dye instilled into cuff. A) Dye instilled into the normal endotracheal their suggestions and to work with them toward the tube travels all the way to the cuff. B) Dye instilled into the defective endotracheal tube stops at the entrance of the common goal of safe anesthesia for all patients. pilot balloon tubing into the main tubing (arrow in Figure 2A and 2B). APSF NEWSLETTER February 2017 PAGE 70

Anesthesia Patient Safety Foundation Officers, Directors, and Committees, 2017

Board Members Bruce P. Hallbert, PhD George A. Schapiro Committee on Scientific Timothy W. Vanderveen, PharmD Battelle Energy Alliance-Idaho Hillsborough, CA Evaluation Becton Dickinson Executive Committee National Laboratory Marjorie P. Stiegler, MD Officers Idaho Falls, ID Steven K. Howard, MD, Chair Corporate Advisory Chapel Hill, NC Palo Alto, CA Council Mark A. Warner, MD Marjorie P. Stiegler, MD Rebecca S. Twersky, MD APSF President University of North Carolina Karen L. Posner, PhD, Vice Chair George A. Schapiro, Chair New York, NY Mayo Clinic Chapel Hill, NC Seattle, WA APSF Executive Vice President Rochester, MN Timothy W. Vanderveen, PharmD Allison F. Perry Board of Directors Baxter Healthcare San Diego, CA Grant Administrator Jeffrey B. Cooper, PhD (Jimena Garcia) APSF Executive Vice President Shane Angus, AA-C, MSA Maria A. van Pelt, PhD, CRNA Oxford, PA Washington, DC Becton Dickinson Massachusetts General Hospital Boston, MA Peter J. Davis, MD Boston, MA Douglas A. Bartlett Pittsburgh, PA (Timothy W. Vanderveen, Mark A. Warner, MD Boulder, CO PharmD) George A. Schapiro Rochester, MN Richard H. Epstein, MD APSF Executive Vice President David J. Birnbach, MD Miami, FL B. Braun Medical, Inc. Matthew B. Weinger, MD Hillsborough, CA Miami, FL (Michael Connelly) Nashville, TN David B. Goodale, PhD, DDS Steven R. Sanford, JD Casey D. Blitt, MD West Chester, PA ClearLine MD Wando O. Wilson, CRNA, PhD APSF Vice President Coronado, CA (Ann M. Bilyew) Park Ridge, IL Jeana E. Havidich, MD Preferred Physicians Medical Sorin J. Brull, MD Lebanon, NH Cook Medical Risk Retention Group Jacksonville, CA (Dan J. Sirota) Overland Park, KS APSF Committees Gary R. Haynes, PhD, MD Jason R. Byrd, JD Newsletter Editorial New Orleans, LA Dräger Medical Matthew B. Weinger, MD Charlotte, NC Board (David Karchner) APSF Secretary Alfred E. Lupien, PhD, CRNA Vanderbilt University Robert A. Caplan, MD Lorri A. Lee, MD, Co-Editor Sioux Falls, SD Eagle Pharmaceuticals Richland, WA Nashville, TN Redmond, WA David J. Murray, MD (Leslie C. North, RN) Casey D. Blitt, MD Joan M. Christie, MD Steven B. Greenberg, MD, St. Louis, MO Fresenius Kabi, USA Co-Editor APSF Treasurer St. Petersburg, FL Sadeq Ali Quraishi, MD (Angela Lindsey) Coronado, CA Evanston, IL Jerry A. Cohen, MD Boston, MA GE Healthcare (Matti E. Lehtonen) Executive Committee Gainesville, FL Sorin J. Brull, MD Harish Ramakrishna, MD Masimo (Members at Large) Jacksonville, FL Daniel J. Cole, MD Phoenix, AZ (Steven J. Barker, MD, PhD) Douglas A. Bartlett Los Angeles, CA Joan M. Christie, MD St. Petersburg, FL Rebecca S. Twersky, MD MEDNAX Medtronic Jeffrey B. Cooper, PhD New York, NY Boulder, CO Jan Ehrenwerth, MD (Richard L. Gilbert, MD, MBA) Boston, MA Yan Xiao, PhD New Haven, CT Medtronic David J. Birnbach, MD T. Forcht Dagi, MD Dallas, TX University of Miami John H. Eichhorn, MD (Patty Reilly, CRNA) Chicago, IL Committee on Technology Miami, FL Lexington, KY Marcel E. Durieux, PhD, MD Merck A. William Paulsen, PhD, AA-C, Robert A. Caplan, MD Charlottesville, VA Jeffery S. Vender, MD (Rachel A. Hollingshead, RN) Redmond, WA Winnetka, IL Chair Jan Ehrenwerth, MD Hamden, CT Mindray Daniel J. Cole, MD New Haven, CT Wilson Somerville, PhD, Editorial (Jeffrey M. Corliss) Patty Reilly, CRNA University of California, Los Assistant Jeffrey M. Feldman, MD Strategic Relations Director Nihon Kohden America Angeles Winston-Salem, NC (Kathy Hart) Los Angeles, CA Philadelphia, PA Medtronic Committee on Education North American Partners in David M. Gaba, MD Jenney E. Freeman, MD Christopher Easter and Training Anesthesia (NAPA) Stanford University Waltham, MA Pall Medical (John Di Capua, MD) Palo Alto, CA David M. Gaba, MD Maria A. van Pelt, PhD, CRNA Jeffrey M. Feldman, MD Chair, Boston, MA Executive Committee Palo Alto, CA Philadelphia, PA NorthStar Anesthesia (Committee Chairs) David B. Goodale, PhD, DDS Tetsu (Butch) Uejima, MD Jenney E. Freeman, MD (Joshua L. Lumbley, MD) West Chester, PA Vice-Chair, Wilmington, DE Steven K. Howard, MD Respiratory Motion Pall Corporation Chair, Committee on Scientific Steven B. Greenberg, MD David J. Birnbach, MD Tong Joo Gan, MD (Dustin R. Crumby, RN) Evaluation Evanston, IL Miami, FL Stonybrook University PharMEDium Services Stanford University Linda Groah, RN Brian J. Cammarata, MD Julian M. Goldman, MD (TBD) Palo Alto, CA Tucson, AZ Denver, CO Boston, MA PhyMED Healthcare Group Lorri A. Lee, MD Amy Holcomb, RN Joan M. Christie, MD Nikolaus Gravenstein, MD (John C. Dalton, MD) Co-Editor, APSF Newsletter Cherry Hill, NJ St. Petersburg, FL Gainesville, FL Richland, WA Preferred Physicians Medical Rachel A. Hollinghead, RN Timothy N. Harwood, MD Thomas Green (Steven R. Sanford, JD) Steven B. Greenberg, MD Merck Winston-Salem, NC Paragon Service Co-Editor, APSF Newsletter Respiratory Motion NorthShore University Steven K. Howard Jeana E. Havidich, MD Casey Harper (Diana Gelston) Palo Alto, CA Lebanon, NH Northwestern University HealthSystem Sheridan Healthcare Evanston, IL Lorri A. Lee, MD Armi Holcomb, RN Michael B. Jaffe, PhD (Andrew Greenfield, MD) Richland, WA Cherry Hill, NJ Wallingford, CT A. William Paulsen, PhD, AA-C Smiths Medical Chair, Committee on Technology Matti E. Lehtonen Jeffrey Huang, MD David T. Jamison (Tom Ulseth) Frank Netter School of Medicine Madison, WI Winter Park, FL ECRI Hamden, CT Spacelabs Samsun (Sem) Lampotang, PhD Ana P. McKee, MD David Karchner (Andrew Levi) Maria A. van Pelt, PhD, CRNA Chicago, IL Gainesville, FL Dräger Medical Massachusetts General Hospital Teleflex Sandeep Markan, MBBS Boston, MA Robert C. Morell, MD Tom Krejcie, MD (Whitney Reynolds) Niceville, FL Houston, TX Chicago, IL Richard C. Prielipp, MD The Doctors Company Foundation A. William Paulsen, PhD, AA-C Tricia A. Meyer, PharmD Andrew Levi Patient Safety Section Editor, (Leona England Rice) Anesthesia and Analgesia Hamden, CT Temple, TX Spacelabs Minneapolis, MN Richard C. Prielipp, MD, FCCM May C. Plan-Smith, MD James H. Philip, ME (E), MD US Anesthesia Partners (Kristin Bratberg) Consultants to Executive Minneapolis, MN Boston, MA Boston, MA Committee Lynn J. Reede, DNP, MBA, CRNA Lianne Stephenson, MD Robert H. Thiele, MD Casey D. Blitt, MD (APSF Treasurer) John H. Eichhorn, MD Park Ridge, IL Madison, WI Charlottesville, VA University of Kentucky Steven R. Sanford, JD Ankeet D. Udani, MD Kevin Tissot Mark A. Warner, MD Lexington, KY Overland Park, KS Durham, NC GE Healthcare (APSF President) APSF NEWSLETTER February 2017 PAGE 71

Letter to the Editor: Error in Inhaled Nitric Oxide Setup Results in “No Delivery of iNO” by Nicole Giglio, MS, CRNA, Jeffery Lyvers, MD, and Bhawana Dave, MD

Right ventricular (RV) dysfunction is a lation.2 The RT connected the iNO to the anesthe- introducing the iNO module to the anesthesia machine common after left ventricular assist sia circuit and set the concentration for 20 ppm, as well as a checklist to confirm all steps have been device (LVAD) insertion, occurring in approxi- with confirmation of delivery as seen on the iNO taken to successfully and safely introduce iNO into the mately 20-50% of patients.1 Multiple pathophysio- machine console. Within a few minutes of connec- anesthesia circuit (see Table 1). logic factors are implicated, including pre-existing tion, a reading of “0 ppm” was suddenly seen on RV contractile dysfunction as well as abnormal the iNO machine console and an alarm sounded. Nicole Marie Giglio, is a Certified Registered Nurse geometric changes in the interventricular septum Anesthetist in the Department of Anesthesiology and As an immediate attempt to troubleshoot this due to LV decompression, RV distention and isch- Perioperative Medicine at Tufts Medical Center, sudden cessation of iNO administration, the flows emia as a result of augmented venous return, and Boston, MA. on the anesthesia machine were decreased, with increased pulmonary vascular resistance (PVR) an observed subsequent rise in detected iNO con- Jeffery Lyvers, MD, is a resident physician in the secondary to increased RV afterload.2-4 The mecha- centration to 20 ppm. At this time, another anes- Department of Anesthesiology and Perioperative Med- nisms described have been observed in patients icine at Tufts Medical Center, Boston, MA. with pulsatile as well as continuous flow devices; thesiologist entered the room and began to assist however, these unfortunate sequela are more often in further investigation. Within minutes, the Bhawana Dave is an attending anesthesiologist and manifested in the former. Inhaled nitric oxide cause of delivery failure was determined; the iNO Cardiac Anesthesia Fellowship Director in the Depart- (iNO) is a selective pulmonary vasodilator that dif- system was found attached to the expiratory limb ment of Anesthesiology and Perioperative Medicine at fuses into pulmonary vascular smooth muscle of the anesthesia machine and not the inspiratory Tufts Medical Center, Boston, MA. limb. We also identified a critical fault in exterior resulting in vasodilation via stimulation of guanyl- None of the authors have any conflicts of interest labeling on the anesthesia machine itself. Stickers ate cyclase and production of cyclic guanosine to disclose. labeled “Expiratory” and “Inspiratory” had been monophosphate. This vasodilation allows for References marked improvement in acute RV dysfunction placed incorrectly over the back of each limb, out of sight in the front of the machine, and only visi- 1. Ichinose F, Roberts JD, Zapol WM. Inhaled nitric after LVAD placement through its ability to reduce oxide a selective pulmonary vasodilator: current uses PVR, decrease RV distension, and minimize wall ble from the back of the limbs where the RT would and therapeutic potential. Circulation 2004;109: 3106- tension and myocardial oxygen consumption.3 pass the iNO circuit through to be attached to the 3111. anesthesia machine. Coincidentally, this ventila- We report a potential safety risk in the assem- 2. Ceccarelli P, Bigatello LM, Hess D, Kwo J, Melendez L. tor had just been serviced, and although the limbs bly and delivery of iNO in the OR through a Inhaled nitric oxide delivery by anesthesia machines. were correctly labeled within the housing of the Anesthesia Analogues 2000; 90: 482–8. Dräger Apollo anesthesia machine. Immediately ventilator, visualization of the manufacturer prior to weaning a patient from cardiopulmonary 3. Lovich MA, Pezone MJ, Wakim MG, Denton RJ, labeling could not be made without pulling the bypass after implantation of an LVAD, a respira- Maslov MY, Murray MR, Tsukada H, Agnihotri AK, ventilator drawer out. This issue was detected and Roscigno RF, Gamero LG, Gilbert RJ. Inhaled nitric tory therapist (RT) was called to the operating promptly corrected (see Figure 1). oxide augments left ventricular assist device capacity room (OR) for the connection of 20 ppm of iNO by ameliorating secondary right ventricular failure. through the breathing circuit of the anesthesia Because of the potential for delayed treatment and/ ASAIO Journal 2015; 61: 379-385. machine. Per protocol, fresh gas flow (FGF) was or incorrect delivery of iNO in the OR, we propose that 4. MacGowan GA, Schueler S. Right heart failure after increased to 8 L/min on the anesthesia machine a protocol for iNO in the OR should include the direct left ventricular assist device implantation: early and in an effort to keep FGF higher than minute venti- participation of the anesthesia provider in properly late. Current Opinion in Cardiology 2012; 27: 296–300.

A Protocol for Initiation of iNO in the Cardiac Operating Room Through the Anesthesia Machine Inspiratory Limb 1. For cardiac cases with a known iNO need (i.e. LVAD, transplantation), RT will be notified by anesthesia prior to the start of the case. For all other iNO needs, RT will be notified ASAP after the decision has been iNO made to incorporate iNO therapy. Injection Module Expiratory 2. RT will bring iNO machine into the outer core and leave machine plugged in directly outside of OR door Limb that will be utilizing it. Anesthesia team should confirm this process through visual inspection. 3. RT will then be paged to the OR prior to weaning from cardiopulmonary bypass (CPB). 4. RT will then bring iNO into the OR, run through appropriate set-up checklist, and then set desired parts per million (PPM) to begin therapy. 5. The anesthesia team will set fresh gas flow (FGF) on the anesthesia machine to a minimum of 8L/min. 6. Identification of the inspiratory limb of the anesthesia machine and connection of the iNO system will be done in collaboration with RT by the anesthesia team. 7. Once connected and iNO delivery is confirmed, the system will be monitored continuously by RT throughout the process of weaning from CPB. 8. Once the patient has been successfully weaned from CPB, the RT may leave the OR and will then be paged to return once the anesthesia team is ready for patient transport to the cardiothoracic intensive Figure 1. iNO module correctly connected to the inspi- care unit (CTU). ratory limb of a Dräger Apollo anesthesia machine. APSF NEWSLETTER February 2017 PAGE 72

Letter to the Editor: Air Leak in a Pediatric Case—Don’t Forget to Check the Mask! by Elvera L. Baron, MD, PhD, and Barbara M. Dilos, DO Scrupulous anesthesia equipment check is part ogy team examined several additional masks from airway easily becomes obstructed. Oral airways may of a routine pre-operative checklist for all pediatric the same batch of the same size, and did not dis- help forwardly displace an oversized tongue. cases. We describe a case of a defective face mask, cover similar defects. Compression of submandibular soft tissues the integrity of which was not assessed prior to use. The supplier of the mask was contacted. Visual should be avoided during mask ventilation to pre- This had the potential to result in the adverse out- inspection confirmed that the glue used to seal the vent further upper airway obstruction. come of a pediatric patient if not promptly detected. air cuff of the face mask had multiple gaps in it Based on our experience, if an air leak is heard An otherwise healthy 3-week old infant pre- between the crown and the bladder of the mask, or suspected during attempted bag-mask ventila- sented for pyloromyotomy under general anesthe- while no leak was detected in the cushion itself. tion, we recommend to examine the source of such sia. Despite pre-oxygenation and normal vital Since samples were re-inflated and compressed by air leak systematically, rapidly, and thoroughly. signs, efforts to bag-mask ventilate the infant via hand, potential root causes for this failure mode included operator error setting up adhesive dis- face mask during a rapid sequence induction Once the machine and circuit are found to function pense quantity. Several improvements were report- where the first attempt at intubation was not suc- properly, the leak source is then narrowed to the edly made since the production of this lot with cessful proved to be inadequate and unsuccessful. face mask itself. We advise adding inspection of the controls in place to mitigate this failure mode. An appropriately sized oral airway was placed. face mask and assessment of its integrity as part of The anesthesia providers detected a sound sug- The risk of cardiac arrest in pediatric anesthetic the routine pre-operative checklist for all cases. 1 gesting a leak. The appropriately sized bubble cases is approximately 1.4 in 10,000. Infants Elvera L. Baron, MD, PhD, is a Fellow in the Adult accounted for 55% of all anesthesia-related arrests, gum flavored latex-free face mask was firmly re- Cardio-Thoracic Anesthesiology Program in the with those younger than 1 month of age having the applied to the patient’s face, with concurrent chin Department of Anesthesiology at The Mount Sinai greatest risk. Eighty-two percent of cardiac arrests lift-jaw thrust maneuver in order to maximize ven- Hospital, New York, NY. tilation, yet no chest rise or end tidal CO were occurred during induction of anesthesia; bradycar- 2 dia, hypotension, and a low SpO frequently pre- noted. Again, a leak in the circuit was suspected, 2 Barbara M. Dilos, DO, is an Assistant Professor, ceded these arrests. Respiratory mechanisms leading and both the machine and the circuit were quickly Director of Pediatric Anesthesia in the Department of to cardiovascular collapse included laryngospasm, re-examined. A loud leak around the face mask Anesthesiology at Elmhurst Hospital Center, Queens, NY. airway obstruction, and difficult intubation, in was heard despite adequate seal between face decreasing order. In most cases, the laryngospasm Neither author has any financial conflicts of interest mask and patient’s face, with precipitant hypox- occurred during induction. Infants have a reduced to disclose. emia. Leak in the mask itself was presumed. After margin for error. Since hypoxia from inadequate References: the defective mask was replaced by another one of ventilation is exacerbated by neonatal and pediatric the same size, ventilation efforts became markedly respiratory physiology, it remains a common cause 1. Greene NH, Bhananker SM, Posner KL, Domino KB. improved, leading to stabilization of the patient’s The Pediatric Perioperative Cardiac Arrest (POCA) Regis- of perioperative morbidity and mortality. Pulse try. In: Barach PR, Jacobs JP, Lipshultz SE, Laussen PC vital signs. The patient then underwent intuba- oximetry and capnography assume an even more (eds). Pediatric and congenital cardiac care. Volume 2: tion, maintenance, and emergence from anesthesia important role in infants as compared to older chil- Quality improvement and patient safety. London: uneventfully, and fully recovered in the post-anes- dren or adults. Specifically contoured face masks are Springer-Verlag, 2015. thesia care unit without any additional concerns. designed to minimize dead space and to aid in ade- 2. Morgan GE, Mikhail MS, Murray MJ. Clinical anesthe- 2 quate ventilation efforts. It is crucial to select equip- siology. 5th edition. New York: Lange Medical Books/ ment appropriate for age and size as the infant McGraw Hill Medical Publications Division, 2006.

Anesthesia Patient Safety Foundation ANNOUNCES THE PROCEDURE FOR SUBMITTING GRANT APPLICATIONS

DEADLINE TO SUBMIT THE LETTER OF INTENT (LOI) FOR AN APSF GRANT AWARD TO BEGIN JANUARY 1, 2018, IS: Figure 1. Note the apparent small gap (see red circular out- FEBRUARY 13, 2017 line) in the pediatric mask on the left side of the figure. • LOI will be accepted electronically beginning January 3, 2017. After conclusion of the surgery, closer exami- nation revealed two small defects at the brim of • The maximum award is $150,000 for a study conducted over a maximum of the face mask, accounting for resultant air leak 2 years to begin January 1, 2018. during attempted hand ventilation. Though the • Based on the APSF’s Scientific Evaluation Committee’s evaluation of these mask was examined pre-operatively for its ability LOIs, a limited number of applicants will be invited to submit a full proposal. to hold air in the inflatable cushion of the mask, this did not preclude the leak from occurring since Instructions for submitting a Letter of Intent can be found at the defect responsible for the leak was found at the http://www.apsf.org/grants_application_instructions.php brim of the mask (see Figure 1). The anesthesiol- APSF NEWSLETTER February 2017 PAGE 73

The Anesthesia Professional’s Role in Patient Safety During TAVR (Transcatheter Aortic Valve Replacement) by Todd E. Novak, MD and Suraj Parulkar, MD

“By failing to prepare, you are preparing to fail.” Benjamin Franklin

Transcatheter Aortic Valve Replacement (TAVR) is quickly becoming an everyday proce- dure seen in operating rooms and cardiac catheter- ization suites throughout the country. With aortic stenosis being one of the most common valvular heart conditions in a continually aging population, these numbers are only expected to increase. To date, it is estimated over 200,000 TAVR procedures have been performed worldwide.1 It is imperative that anesthesia professionals have an understand- ing of this transformative procedure and the unique anesthetic challenges these patients pres- Figure 1. SAPIEN 3 Transcatheter valve. Courtesy of ent in order to provide the safest level of care. Edwards Lifesciences LLC, Irvine, CA. Edwards, Edwards Lifesciences, and SAPIEN 3 are trademarks of Figure 2. The Medtronic CoreValve® Evolut R Transcatheter History of TAVR Edwards Lifesciences Corporation. Valve. Courtesy of Medtronic, Inc., Minneapolis, MN. TAVR was first performed as a proof-of-con- cept procedure by Cribier et al. in Paris, France, on lower stroke and mortality rates for TAVR,8 the bility. The Sapien valve is a balloon-expandable April 16, 2002, on a patient with severe aortic ste- Federal Drug Administration has recently device that requires rapid ventricular pacing (rate nosis and cardiogenic shock as a treatment of last approved TAVR for intermediate-risk‡ patients.9 160-220 beats/minute) at the time of deployment 2 resort. The patient experienced a dramatic There is also an interest in advancing efforts to in order to minimize arterial pulse pressure and improvement in his heart failure symptoms post- include the recommended use of TAVR as an alter- transaortic flow helping to reduce the risk of operatively, thus, demonstrating the feasibility of native to SAVR for even low-risk§ patients, with migration or ejection of the valve into the aorta. this remarkable new procedure. Since that two large randomized trials underway in the US.10 Conversely, the CoreValve is self-expanding and moment 16 years ago, TAVR has seen a rapid evo- does not require pacing since it is gradually lution, and after being validated through several Overview of the Procedure released into position. The CoreValve is a longer 3-6 rigorous clinical trials, has now become a There are several commercially available TAVR profile device that can also be partially recaptured common, everyday procedure. TAVR has revolu- systems approved for use in Europe and two in in the sheath and repositioned if necessary. Bal- tionized the treatment of severe aortic stenosis the United States. The two newest generation loon aortic valvuloplasty is occasionally per- since patients that were considered non-operable valve systems approved for use in the United formed to facilitate placement of either prosthetic for traditional surgical aortic valve replacement States are the Sapien 3 (Edwards Lifescience, valve. Rapid ventricular pacing is routinely (SAVR) due to significant comorbidities are now Irvine, CA, Figure 1) and the CoreValve Evolut-R employed during this step as well. While the vast given this treatment option. Many of these (Medtronic, Minneapolis, MN, Figure 2). Both the majority of patients spontaneously recover from patients go on to experience sustained quality of Sapien and CoreValve systems are most com- these brief pacing episodes, management of con- life with improved functional status for many monly inserted via a retrograde transfemoral tinued hemodynamic instability must be prompt. years,3 whereas medically managed patients have approach. For patients with ilio-femoral arterial Patients with severe aortic stenosis and concomi- a 1-year mortality of 51% and an average survival access not amenable to this percutaneous tech- tant left ventricular hypertrophy do not tolerate of only 1.8 years.6 TAVR has been accepted by the nique due to severe peripheral vascular disease, hypotension for an extended period of time due to American Heart Association/American College of tortuosity, or aortic disease, other options may lack of coronary flow reserve and perfusion mis- Cardiology (AHA/ACC) as a Class I indication include subclavian/axillary, transaortic, transapi- match, even in the absence of coronary disease. and is considered the standard of care in these cal, transcaval, and even a transcarotid approach. Interventions can range from bolus vasopressor non-operable* patients and as a Class IIa indica- While both systems provide patients with similar administration for transient hypotension to defi- tion in patients who are operative candidates but outstanding outcomes,11,12 it is important to note brillation for induced ventricular fibrillation and at high-risk† for mortality and complications after that these two device systems differ in their initiation of cardiopulmonary bypass for sustained SAVR.7 Now, with data from the PARTNER-2A deployment techniques that, in turn, have implica- hypotension, coronary occlusion, or annular rupture. randomized clinical trial that have demonstrated tions for the development of hemodynamic insta- Patients with pre-existing first-degree atrioventricu- lar block, left anterior hemiblock, right bundle branch * non-operable definition is challenging but agreed to be >50% mortality at 30 days or irreversible morbidity1 block, and those receiving a CoreValve are at higher † 3 Society of Thoracic Surgeons (STS) predicted risk of operative mortality score ≥10% or at a ≥15% risk of mortality at 30 days risk of requiring pacing immediately after valve ‡ STS predicted risk of operative mortality score ≥4% and ≤8%8 § STS predicted risk of operative mortality score <2%10 See “Aortic Valve,” Next Page APSF NEWSLETTER February 2017 PAGE 74

Aortic Valve Replacement Procedure Revolutionized with Percutaneous Approach

“Aortic Valve,” From Preceding Page lined process known as “minimalist” TAVR.15,16 however, MAC patients had significantly lower When the vasculature of the patient is amenable to 30-day mortality (2.9% vs. 4.1%, p=0.029), a lower deployment as well as postoperatively.13 Since the a percutaneous transfemoral approach, this composite mortality and/or stroke rate (4.8% vs. CoreValve structure extends more deeply into the method streamlines the entire perioperative pro- 6.4%, p=0.019), and a shorter hospital length of left ventricular outflow tract where the atrioventricu- cess by using MAC anesthesia, intraoperative stay (6 d vs. 6.7 d, p<0.0001). Even though these lar conduction system passes superficially, these transthoracic echocardiography (TTE), reduction advantages remained after a propensity matched patients are particularly at risk. A reliable mecha- or elimination of pre-implantation balloon valvu- analysis, as a retrospective observational study, nism for immediate pacing is required for all TAVR loplasty, and well-defined postoperative care selection bias could have unintentionally been patients but a heightened sense of awareness is 1 plans. The possible benefits of MAC over general introduced into the data since non-transfemoral needed for patients with these preoperative electro- anesthesia include less hemodynamic instability patients generally have more co-morbid condi- cardiogram abnormalities and those receiving the from anesthetic drugs, the avoidance of intubation CoreValve. tions. For instance, outcomes may be better using and mechanical ventilation, faster postoperative MAC anesthesia solely because it is a much more recovery, and the ability to monitor for central ner- common technique at high-volume centers than at General versus Monitored vous system embolic events. Since TTE, and not Anesthesia Care (MAC): emerging programs that employ general anesthe- TEE, is used to evaluate the prosthetic valve after sia and where operators encounter a steep learn- deployment, the ability to diagnose paravalvular Although the first TAVR was performed with ing curve. Although it is unknown whether regurgitation may be limited; however, with local anesthesia and minimal sedation in a mori- anesthesia type is directly associated with newer valve design modifications and more pre- bund patient, the early stage of TAVR develop- improved outcomes without a prospective, ran- cise valve-sizing algorithms, the rate of paravalvu- ment saw almost uniform use of general domized study, these data clearly signify a trend lar regurgitation has decreased significantly.1 In anesthesia. It is still the most common type of towards an increasing number of programs per- 14 cases where aortography shows no paravalvular anesthesia used today in the United States. Gen- forming TAVR without general anesthesia. From leak, patent coronary arteries, and good prosthetic eral anesthesia allows for more control of the pro- April 2014 until June 2015, the percentage of pro- cedural environment with a secure airway and position, there is no need for immediate post implant echo imaging. This latter point helps grams employing moderate sedation or MAC completely immobile patient. Since ventilation is 14 reduce procedure time and decreases the demands increased from 10% to almost 30%. This transi- controlled, a period of apnea can be provided tion from general to MAC anesthesia has largely that may help avoid unnecessary movement of on the echocardiography staff and physicians. already occurred internationally, where TAVR has the heart during deployment of the valve. It also Another potential benefit to a minimalist tech- been in general use for several more years than in gives the cardiologist as much time as needed to nique is reducing the incidence of postoperative the US. perform the procedure. In addition, general anes- delirium (PD). These patients are at unique risk for thesia allows for the use of transesophageal echo- developing PD given their advanced age, frailty, There still are risks associated with TAVR per- cardiography (TEE), in particular 3D TEE, to and significant comorbidities. Abawi and col- formed under MAC anesthesia. The anesthesia assist with positioning of the valve, the assess- leagues recently published a retrospective observa- provider must always be prepared for any contin- ment of any paravalvular regurgitation, and tional study demonstrating PD was more frequent gency plan and be able to convert to a general immediate diagnosis of cardiac perforation if in nontransfemoral approaches (50% vs 10%, anesthetic promptly. The rate of conversion to gen- hypotension is persistent. TEE is also valuable in p<0.001) and in those that received general anesthe- eral anesthesia in most recent experience is under assessing under-filling of the left ventricle as an sia (50% vs. 15%, p<0.001).17 Since all nontransfem- 2%, but has been reported as high as 5-6%.14 The etiology of rapid or unfavorable hemodynamic oral procedures were performed under general most dramatic cases are when annular rupture or changes. In the earlier stages of TAVR develop- anesthesia, it could not be determined whether cardiac perforation occur. Embolization of the ment, general anesthesia was warranted when there was an independent effect from the type of TAVR valve into the left ventricle may require there was a higher complication rate and the anesthesia (general vs. MAC). A more important rapid conversion to open surgery. In smaller duration of the procedure was longer. Presently, factor in PD may be that patients with severe vascu- patients, the delivery system can obstruct the arte- with recent technological advancements in the lar disease, relegated to a nontransfemoral rial supply to a lower extremity causing ischemia newer generation TAVR systems, along with approach, are at higher risk for cerebral emboli and and pain, let alone arterial dissection. Further- better operator experience and implementing ischemia during the procedure. Moreover, non- more, many of these elderly patients also suffer standardized protocols, there has been a much transfemoral procedures involve a longer intensive from spinal stenosis and remaining motionless in lower complication rate and a trend toward using care unit stay, more pain and opioid use, and more the supine position after a period of time can be MAC anesthesia. Some of the TAVR innovations postoperative inflammation, which all may lead to nearly impossible, necessitating conversion to a that have permitted this transition to MAC anes- PD. Further studies investigating whether the anes- general anesthetic. Therefore, it may be prudent to thesia include significantly lower profile delivery thetic type can lead to decreased postoperative have airway equipment (laryngoscopes, endotra- systems, less paravalvular regurgitation from delirium are forthcoming. cheal tubes, laryngeal mask airway), vasopressors, improved valve design, and enhanced device Although previous small studies did not reveal and blood checked and ready for any critical life delivery systems.1 Although MAC anesthesia is a difference in short or intermediate-term survival threatening situation that may arise. Moreover, now being used in many uncomplicated cases, between general and MAC anesthesia,18-20 recent open communication between all operating room general anesthesia is still required for most non- data are emerging that MAC anesthesia may be team members, both before and during the proce- transfemoral approaches, in some high-risk associated with improved outcomes. The largest dure, is particularly important to avoid prevent- patients, and when TEE guidance is used, such as observational TAVR study to date compared out- in patients with chronic kidney disease to help able complications. This “heart team” comes in patients who received general anesthesia minimize the use of x-ray contrast for procedure collaborative model has a Class I indication from or MAC anesthesia in all 10,997 patients who guidance. the AHA/ACC as it seeks to optimize patient underwent TAVR in the United States from April safety and clinical outcomes.7 Many high-volume centers now use almost 2014 through June 2015.14 The success of the proce- exclusively MAC anesthesia as part of a stream- dure was comparable between the two techniques; See “Aortic Valve,” Next Page APSF NEWSLETTER February 2017 PAGE 75

TAVR is Becoming More Commonplace in US

“Aortic Valve,” From Preceding Page We would like to acknowledge Ted Feldman, MD, 9. FDA News Release. August 18, 2016. http://www.fda. gov/NewsEvents/Newsroom/PressAnnouncements/ Director of the Cardiac Catheterization Laboratory, ucm517281.htm Summary NorthShore University HealthSystem and Michael 10. The safety and effectiveness of the SAPIEN 3 Transcath- TAVR has revolutionized the care of patients Salinger, MD, Clinical Assistant Professor of Cardiol- eter Heart Valve in low risk patients with aortic stenosis with severe aortic stenosis, proving in randomized ogy, NorthShore University HealthSystem for assis- (PARTNER 3). https://clinicaltrials.gov/ct2/show/ comparisons with standard surgery to be a supe- tance in review of the manuscript. Dr. Feldman has NCT02675114 rior treatment alternative to SAVR in patients that received research grants and has served as a consultant 11. Abdel-Wahab M, Neumann FJ, Mehilli J, et al. 1-Year outcomes after transcatheter aortic valve replacement are at prohibitive, high, and intermediate surgical for Abbott, Edwards, BSC and Gore. Dr. Salinger has with balloon-expandable versus self-expandable valves: risk. Recent data demonstrate MAC anesthesia served as proctor and consultant for Edwards Laborato- results from the CHOICE randomized clinical trial. J Am provides a similar rate of procedural success when ries Sapien TAVR valve and Boston Scientific Lotus Coll Cardiol 2015; 66: 791-800. compared to general anesthesia; however, whether TAVR valve. 12. Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison MAC anesthesia actually leads to improved of balloon-expandable vs. self-expandable valves in References patients undergoing transcatheter aortic valve replace- patient safety and better outcomes in these ment: the CHOICE randomized clinical trial. JAMA patients remains to be elucidated. While techno- 1. Vahl TP, Kodali SK, Leon MB. Transcatheter aortic valve 2014; 311: 1503-1514. replacement 2016: a modern-day “through the looking- logical advances and a low complication rate glass” adventure. J Am Coll Cardiol 2016;67:1472–1487. 13. Siontis GCM, Jüni P, Pilgrim T, et al. Predictors of perma- allowed for the introduction of the minimalist nent pacemaker implantation in patients with severe 2. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous aortic stenosis undergoing TAVR: a meta-analysis. J Am TAVR approach under MAC anesthesia, the anes- transcatheter implantation of an aortic valve prosthesis Coll Cardiol 2014; 64: 129-140. thesia provider must always be prepared to for calcific aortic stenosis: first human case description. Circulation 2002; 106:3006-8. 14. Giri, J. Moderate sedation vs. general anesthesia for address problems that may arise. A well-designed transcatheter aortic valve replacement: An STS/ACC and thoughtful anesthetic plan should always be 3. Mack MJ, Leon MB, Smith CR, et al. PARTNER 1 trial Transcatheter Valve Therapy Registry analysis. SCAI accompanied by an understanding of the sequence investigators. 5-year outcomes of transcatheter aortic Annual Meeting, May 2016. valve replacement or surgical aortic valve replacement 15. Motloch LJ, Rottlaender D, Reda S, et al. Local versus of steps involved in the TAVR procedure so that for high surgical risk patients with aortic stenosis (PART- general anesthesia for transfemoral aortic valve implan- NER 1): a randomised controlled trial. Lancet 2015; 385: hemodynamic perturbations and procedural com- tation. Clin Res Cardiol 2012; 101:45-53. plications can be anticipated and addressed 2477–2484. 16. Kasel AM, Shivaraju A, Schneider S, et al. Standardized appropriately. As TAVR moves toward use in low 4. Reardon MJ, Adams DH, Kleiman NS, et al. 2-Year out- methodology for transfemoral transcatheter aortic valve risk patients, the importance of readiness to comes in patients undergoing surgical or self-expanding replacement with the Edwards Sapien XT valve under transcatheter aortic valve replacement. J Am Coll Cardiol fluoroscopy guidance. J Invasive Cardiol 2014; 26: 451-461. manage catastrophic complications becomes even 2015;66:113–121. more important. There should be contingency 17. Abawi M, Nijhoff F, Agostino P, et al. Incidence, predic- 5. Thyregod HG, Steinbruchel DA, Ihlemann N, et al. tive factors, and effect of delirium after trancatheter plans for anything from major hemodynamic Transcatheter versus surgical aortic valve replacement in aortic valve replacement. JACC Cardiovasc Interv 2016; changes and catastrophic complications to intoler- patients with severe aortic valve stenosis: 1-year results 25;9:160-8 from the all-comers NOTION randomized clinical trial. J ance to MAC anesthesia. Am Coll Cardiol 2015;65:2184–2194. 18. Gauthier C, Astarci P, Baele P, et al. Mid-term survival after transcatheter aortic valve implantation: results with Todd Novak is an attending anesthesiologist at 6. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic- respect to the anesthetic management and to the access NorthShore University HealthSystem and Clinical valve implantation for aortic stenosis in patients who route (transfemoral versus transapical). Ann Cardiac Assistant Professor at the University of Chicago Pritz- cannot undergo surgery. N Engl J Med 2010; 363:1597-607. Anaesthesia 2015;18: 343-35. ker School of Medicine. 7. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ 19. Oguri A, Yamamoto M, Mouillet G, et al. Clinical out- ACC guideline for the management of patients with val- comes and safety of transfemoral aortic valve implanta- Suraj Parulkar is an attending anesthesiologist at vular heart disease: a report of the American College of tion under general versus local anesthesia. Circ Northwestern Memorial Hospital and Clinical Instruc- Cardiology/American Heart Association Task Force on Cardiovasc Interv 2014;7:602-610. Practice Guidelines. J Am Coll Cardiol 2014; 63: e57-e185. tor of Anesthesia at the Northwestern Feinberg School 20. Balanika M, Smyrli A, Samandis G, et al. Anesthetic of Medicine. 8. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or sur- management of patients undergoing transcatheter aortic None of the authors have any disclosures pertinent gical aortic-valve replacement in intermediate-risk valve implantation. J Cardiothoracic and Vasc Anesth 2014; patients. N Engl J Med 2016; 374: 1609-20. 28:285-289. to this manuscript.

Request for Applications (RFA) for the SAFETY SCIENTIST CAREER DEVELOPMENT AWARD (SSCDA) Application deadline: May 1, 2017

APSF is soliciting applications for training grants to develop the next generation of patient safety scientists. APSF will fund one ($150,000 over 2 years) Safety Scientist Career Development Award to the sponsoring institution of a highly promising new safety scientist. Recipients will be notified July 1, 2017, and awards will be scheduled for funding to begin October 1, 2017. Please contact [email protected] to request the SSCDA GRANT GUIDELINES AND APPLICATION. Anesthesia Patient Safety Foundation NONPROFIT ORG. Charlton 1-145 U.S. POSTAGE Mayo Clinic PAID WILMINGTON, DE 200 1st Street SW PERMIT NO. 1858 Rochester, MN 55905

APSF NEWSLETTER February 2017

Also in This Issue: APSF President Robert K. Stoelting, MD: A Tribute to 19 Years of Steadfast Leadership 2016 President’s Annual Report 2016 APSF BOD Workshop Report: Conflict in the OR Large Anesthesia Groups/Practice Management Companies Discuss the Impact of Production Pressures on Patient Safety with APSF Leaders Distractions in the Workplace Safety Issues in Transcatheter Aortic Valve Replacements 2016 National Geriatric Surgical Initiatives 2017 Grant Recipients