The FMEA I Wish I Did – Hurley Smith

The FMEA I wish I did
I failed again. This time it’s still too raw for me to embrace the learning quite yet. This will be my therapy: a thousand words or less to help me reflect, discern, and grow.

It was a “right care, right place, right time” project. The literature says that colon cancer screening with an at-home fecal immunochemical test (FIT) is just as effective as a colonoscopy. FITs are much less expensive and invasive for patients so, how do we influence patients to choose FIT? This was the scientific question at the heart of the project. To answer it, the team would mail out different forms of outreach in a randomized experiment to see which is most effective.

Reflection #1: This wasn’t a great project for A3 problem solving. I still made an A3 because, let’s face it, everyone wants to see everything on an A3. But what is my role going to be if we weren’t following the A3 process? I hardly do research projects nor massive outreach projects. I found myself on a project that wasn’t appropriate for the method I’m most comfortable with, so I let the team proceed with no method at all. Oof.

To be clear, this project team put a ton of work into preparation and planning. We process mapped, we made estimates for volume & TAKT time, and we collaborated with the key functional areas: lab, mailroom, population health, and or course clinic operations. Despite our best efforts, disaster struck.

The Problem:
The outreach requires patients use a FIT kit and mail it to our lab. It’s a relatively simple process that can be completely blown up by the smallest oversight: an incorrect address on the pre-labeled envelope. What’s more, the FIT test is time-sensitive which means enough delay in being delivered to the lab can result in a terminated test. There are even more downstream problems which have to do with after-hours notifications to providers about terminated tests which I won’t go into here.

In the aftermath of discovering the incorrect address problem, a relatively new team member commented that we should consider performing an FMEA the next time we do something like this.

Reflection #2: I felt defensive. We DID prepare, a LOT. No, we didn’t follow the FMEA method but so what? Would an FMEA have really caught the address problem? Wait, why am I on defense right now?

Suppose I had performed an FMEA with the team. It is almost a certainty that the patient mailing process would have been identified as a critical process to evaluate. It is also reasonable to assume that, had we brainstormed opportunities for the process to fail, someone on the team would have asked about the mailing address. They may also have asked about patient labeling: Does it matter what kind of pen they use? (spoiler-alert: it matters, it really matters).

Reflection #3: Hindsight is 20/20, which means we ought not try to hold ourselves accountable for having knowledge of the unknowable. Instead, let’s be kind to ourselves and one another and not let the learnings from our failures evaporate behind a smoke screen of our own defensiveness.

Also, let’s do more FMEAs… Here’s when the American Society for Quality Control (ASQ) says they’re most helpful:

ASQ Quality Resrouces

Written by Hurley Smith

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Brian T. Bateman, MD, MSc is the Stanford Medicine Professor of Anesthesiology, Perioperative and Pain Medicine and Chair of the Department of Anesthesiology, Perioperative, and Pain Medicine.

Before coming to Stanford, Dr. Bateman served as the Vice Chair for Faculty Development and Chief of the Division of Obstetric Anesthesia in the Department of Anesthesiology, Perioperative and Pain Medicine at the Brigham and Women’s Hospital/Harvard Medical School and as Co-Director of the Harvard Program on Perinatal and Pediatric Pharmacoepidemiology in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital.

Dr. Bateman’s scholarship focuses on the study of medication safety in pregnancy and on predictors and management of maternal morbidity. To address questions in these areas, Dr. Bateman and collaborators at Harvard helped pioneer the use of advanced epidemiological techniques applied to large, routinely collected healthcare utilization data. This research has been funded by multiple R01 grants from the NIH and by grants from the FDA and has been published in leading clinical journals including JAMA, NEJM, BMJ, Lancet, Annals of Internal Medicine, JAMA Pediatrics, JAMA Psychiatry, and Obstetrics and Gynecology. Dr. Bateman’s bibliography contains over 200 publications. This research is frequently cited in clinical reviews and guidelines and has prompted both the FDA and EMA to make labelling changes to medications regarding use in pregnancy. Dr. Bateman is also a founding member of the International Pregnancy Safety Study Consortium (InPress) which is a collaborative effort between investigators from the US and each of the five Nordic countries to pool data for studies evaluating the safety of medications.

Dr. Bateman currently serves as Chairperson of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee after having previously served a 4-year term (2015-2019) as a voting member of this Committee. He was a technical advisor for the recent revision of the Joint Commission’s pain management standards. He has served on expert panels and workshops sponsored by the National Academy of Medicine, the FDA, the NIH, the CDC, and the Department of Health and Human Services, and on multiple grant review committees for the NIH and other funders. He is an Editor for the journal, Anesthesiology, and the textbook, Chestnut’s Obstetric Anesthesia: Principles and Practice.

Dr. Bateman’s work has been recognized by a number of awards including his selection in 2017 by the Society for Obstetric Anesthesia and Perinatology as the Gerard Ostheimer lecturer and in 2018 by the American Society of Anesthesiologists as the James E. Cottrell Presidential Scholar Awardee, which is given to one clinical-scientist each year within 10 years of initial faculty appointment for accomplishment in research.

Faculty development and mentorship has been a central focus of Dr. Bateman’s career. He has mentored numerous trainees who have gone on to outstanding academic careers. As Division Chief and Vice Chair for Faculty Development at the Brigham, he worked particularly hard to advance the careers of women and underrepresented minorities in the Department and to create an environment where everyone is welcomed and has an opportunity to advance.

Dr. Bateman is a Phi Beta Kappa graduate Yale College and received his MD from Columbia University College of Physicians & Surgeons, where he was a member of Alpha Omega Alpha and was awarded the Janeway Prize for the highest achievements and abilities in the graduating class. He completed an internship in internal medicine at Brigham and Women’s Hospital and residency and chief residency in anesthesiology at the Massachusetts General Hospital. He completed a Masters in Epidemiology at the Harvard School of Public Health.

Alice R. Georgitso, MPH, joins the SMCI Advisory Committee as our first Patient Partner. Alice has served as a Patient Partner with the Stanford Health Care (SHC) Patient & Family Partner Program for over 4 years and was appointed Chairperson of the Adult Congenital Heart Program Patient & Family Advisory Council in January 2020. She assisted in developing the Stanford Adult Congenital Heart Program’s Peer-to-Peer Program and serves as a Mentor to ACHD patients pre-and-post-organ transplantation. Alice has presented Stanford Health Care’s C-I-CARE framework for structuring best practice communications and developing relationship-based care approaches with patients and colleagues to 500+ Stanford Medicine Directors, Managers and Clinical Staff.

Alice is a Patient Relations Manager at Stanford Health Care. Within her role, she provides a channel for problem resolution to promote the highest quality of care and service excellence. Alice has also worked as an Unrelated Donor Search Coordinator with the Blood & Marrow Transplant at Stanford Health Care to coordinate allogeneic hematopoietic stem cell transplants through collaborative planning and partnership with the National Marrow Donor Program and SHC clinicians. Prior to her work with SHC, she was the Community Service Foundation Director at San Mateo County Medical Association where she partnered with local stakeholders and clinicians to expand county-wide community health programs to diverse populations. She has also delivered invaluable community health services through her work with the American Heart Association.

Alice earned her Bachelor of Arts in Sociology and Biology at Saint Bonaventure University in Olean, NY and her Master of Public Health from SUNY Buffalo in Buffalo, NY. Alice is a member of The Beryl Institute and Adult Congenital Heart Association professional associations, Donor Network West partner advocating for organ, eye, tissue, and blood donation, and remains an active volunteer with SHC. Alice continues to promote patient-and-family-centered care in both hospital and community settings to support precision health and improve the healthcare experience for patients, families, and clinicians.

John Shook learned about lean management while working for Toyota for 11 years in Japan and the U.S., helping it transfer production, engineering, and management systems from Japan to NUMMI and other operations around the world. While at Toyota's headquarters, he became the company's first American kacho (manager) in Japan. In the U.S., Shook joined Toyota’s North American engineering, research and development center in Ann Arbor, Michigan as general manager of administration and planning. His last position with Toyota was as senior American manager with the Toyota Supplier Support Center in Lexington, Kentucky, assisting North American companies adopt the Toyota Production System. Shook co-authored Learning to See, the book that introduced the world to value-stream mapping. He also co-authored Kaizen Express, a bi-lingual manual of the essential concepts and tools of the Toyota Production System. With Managing to Learn, Shook revealed the deeper workings of the A3 management process that is at the heart of Toyota’s management and leadership.
Shook is an industrial anthropologist with a master’s degree from the University of Hawaii, a bachelor’s degree from the University of Tennessee, and is a graduate of the Japan-America Institute of Management Science. At the University of Michigan, he was director of the Japan Technological Management Program and faculty member of the Department of Industrial and Operations Engineering.
Shook is the author of numerous articles, including "How to Change a Culture: Lessons from NUMMI"; Sloan Management Review, January 2010, which won Sloan’s Richard Beckhard Memorial Prize for outstanding article in the field of organizational development.

The Stanford Medicine Center for Improvement benefits from the diversity of its members and the richness of the experiences that they bring. Although the program continues to evolve from when it first launched in October 2019, we continue to reach out to improvers across Stanford Medicine in the School of Medicine, Stanford Health Care, Stanford Children’s Health, Stanford ValleyCare, UHA and PCHA. We welcome everyone from every discipline and recognize that we are stronger together as we value the contributions of every member of our teams.

Dr. Paul Maggio is the Chief Quality Officer of Stanford Health Care. Prior to being appointed the SHC CQO, he was Vice Chair of Surgery for Clinical Affairs, Associate Chief Medical Officer of Operational Effectiveness, and Associate Director of the Adult Intensive Care Unit. He trained in General Surgery at Brown University and obtained advanced training in Adult Surgical Critical Care and Trauma at the University of Michigan. He holds a Masters of Business Administration from the University of Michigan and is triple board certified in General Surgery, Critical Care, and Medical Informatics. In addition to being a clinician and surgeon, Dr. Maggio participates in the National Committee on Healthcare Engineering for the American College of Surgeons, and his research interests are focused on the delivery of high-value care.

Dr. Maggio received the SHC Board of Hospital Director’s Denise O’Leary Award for Clinical Excellence in 2013

Micah Duchesne joined Stanford Medicine in 2020 as a Principal Consultant project managing the deployment and operations of the Hospital Incident Command System (HICS) for COVID-19. He is now the Administrative Director of Performance Improvement at Stanford Health Care where he leads annual operations planning, improvement consulting, and capability development. Micah is also a Fellow at the Stanford Medicine Center for Improvement.

Before joining Stanford, Micah was an independent consultant for his company Silicon Valley Strategy Group, which partnered with Novartis and the Perelman School of Medicine at the University of Pennsylvania to commercialize cellular therapies. He led a team of clinicians from Europe, Japan, and Australia in designing a global logistics model and quality management system for Kymriah, the world's first approved CAR-T therapy, and helped create an international advisory board aimed at improving global capacity.

Prior to independent consulting, Micah was the Director of Performance Improvement at Kaiser's Santa Clara Medical Center, and he previously held improvement roles of increasing complexity within other health systems. Micah has both a Bachelor of Science in Accounting and Master of Health Services Administration from Mississippi College. He also holds certifications as a Lean Six Sigma Master Black Belt and Project Management Professional.

As a professional, Micah enjoys organizing complex stakeholder ecosystems, clarifying ambiguous goals, aligning visions, and driving high-stakes change. As a human, Micah just enjoys breaking a sweat. While he's not at work, he's at his very own gym in San Jose, CrossFit Moxie. You can find him there coaching olympic weightlifting or working out with his wife. He has a daughter in elementary school and two gym dogs.